En algunos casos, están inventando historias de muertes que nunca ocurrieron.
“Esto es exactamente lo que hacen los grupos antivacunas”, dijo el doctor Peter Hotez, especialista en enfermedades infecciosas y autor de “Preventing the Next Pandemic: Vaccine Diplomacy in a Time of Anti-Science”.
Los grupos antivacunas han afirmado falsamente durante décadas que las vacunas infantiles causan autismo, tejiendo fantásticas teorías de conspiración que involucran al gobierno, las grandes empresas y los medios de comunicación.
Ahora, los mismos grupos culpan a las vacunas de problemas médicos que estos pacientes ya tienen, incluso cuando está claro que la edad o las condiciones de salud subyacentes son las responsables, dijo Hotez.
A medida que más personas mayores reciben sus primeras dosis, muchas inevitablemente sufrirán ataques cardíacos, derrames cerebrales y otros problemas médicos graves, no relacionados con la vacuna sino, más bien, con su edad y deterioro de la salud, dijo el epidemiólogo Michael Osterholm, director del Centro de Investigación y Políticas de Enfermedades Infecciosas de la Universidad de Minnesota.
Por ejemplo, en un grupo de 10 millones de personas, aproximadamente la cantidad de estadounidenses que han sido vacunados hasta ahora, casi 800 personas de entre 55 y 64 años mueren típicamente de ataques cardíacos o enfermedades coronarias en una semana, explicó Osterholm.
Los funcionarios de salud pública “no están preparados” para la avalancha de noticias e historias de las redes sociales que se avecinan, advirtió.
“Los medios de comunicación escribirán una historia de que John Doe recibió su vacuna a las 8 am y a las 4 pm tuvo un ataque al corazón”, dijo Osterholm en su podcast semanal. “Harán suposiciones de que es causa y efecto”.
Los funcionarios de salud pública deben hacer un mejor trabajo comunicando los riesgos, reales e imaginarios, de las vacunas, opinó Osterholm, quien ha estado asesorando al presidente Joe Biden sobre la pandemia, desde su elección.
Los grupos antivacunas como el National Vaccine Information Center y el Children’s Health Defense, fundado por Robert F. Kennedy Jr., ya están avivando los temores sobre un puñado de muertes, principalmente en Europa, que han seguido al lanzamiento mundial de las inmunizaciones.
En un blog, Kennedy se burló de los resultados de la autopsia que concluían que la muerte de una mujer portuguesa no estaba relacionada con una vacuna. Puso en duda las declaraciones de las autoridades médicas de Dinamarca que dijeron que la muerte de dos personas después de vacunarse se debieron a la edad y a la enfermedad pulmonar crónica.
En una entrevista, Kennedy dijo que las muertes posteriores a la vacunación de algunos pacientes muy frágiles y con enfermedades terminales en Noruega, que vivían en hogares, son una señal de peligro. Los funcionarios noruegos han dicho que estos pacientes murieron por sus enfermedades subyacentes, no por la vacuna.
“La coincidencia está resultando ser bastante letal para los receptores de la vacuna contra COVID”, escribió Kennedy. Describió las muertes como sospechosas, acusando a los funcionarios médicos de seguir un “una guía de propaganda de vacunas demasiado familiar” y “artimañas estratégicas”.
Aquí en los Estados Unidos, los que se oponen a las vacunas se han aprovechado de la tragedia del doctor Gregory Michael, un obstetra-ginecólogo de Florida de 56 años, para sembrar dudas sobre la seguridad de las vacunas y la supervisión del gobierno.
Michael murió el 5 de enero después de sufrir una caída catastrófica de las plaquetas, elementos en la sangre que controlan el sangrado, lo que sugiere que pudo haber desarrollado trombocitopenia inmune.
Según una posteo en Facebook de su esposa, Heidi Neckelmann, los médicos probaron una variedad de tratamientos para salvar a su esposo, pero ninguno funcionó.
Un vocero de los Centros para el Control y Prevención de Enfermedades (CDC) dijo que la agencia está investigando la muerte de Michael, al igual que todos los problemas de salud sospechosos relacionados con las vacunas.
Las autoridades de California han recomendado interrumpir las vacunas de un lote particular de Moderna debido a una alta tasa de reacciones alérgicas.
“Tenemos que hacer un seguimiento de cada uno de estos casos”, dijo Osterholm. “No quiero que la gente piense que los estamos barriendo debajo de la alfombra”.
Muchos estadounidenses ya estaban nerviosos por las vacunas contra covid, y el 27% dijo que “probablemente o definitivamente” no recibirían una inyección, incluso si las inyecciones fueran gratuitas y los científicos las consideraran seguras, según una encuesta de diciembre de KFF. (KHN es un programa editorialmente independiente de KFF).
Estas personas pueden ser particularmente susceptibles a la información errónea sobre las vacunas, dijo Rory Smith, investigador de First Draft News, una organización sin fines de lucro que informa sobre noticias falsas que circulan por internet.
Una condición rara
Siete expertos en trastornos sanguíneos entrevistados por KHN dijeron que no hay suficiente información disponible para culpar a la vacuna del declive de Michael, y que los beneficios demostrados de las vacunas superan ampliamente cualquier riesgo potencial de hemorragia.
Incluso si los investigadores concluyen que la vacuna causó la muerte de Michael, aún sería un evento increíblemente raro, dado que se han administrado más de 21.8 millones de dosis.
“Nadie debería pensar en si la vacuna es segura o no”, dijo el doctor James Zehnder, hematólogo y director de patología clínica de Stanford Medicine.
El trastorno hemorrágico de Michael podría haberse desarrollado silenciosamente durante algún tiempo, dijo el doctor Adam Cuker, director del Penn Blood Disorders Center en el Hospital de la Universidad de Pennsylvania. Podría ser una coincidencia que Michael comenzara a mostrar síntomas poco después de la vacunación, agregó.
Aproximadamente 30 estadounidenses son diagnosticados con trombocitopenia inmunitaria cada día.
El momento de la enfermedad de Michael sugiere que tuvo otra causa, dijeron los médicos. Según la publicación de Facebook de su esposa, sus problemas de sangrado comenzaron tres días después de su primera vacuna de covid. El cuerpo necesita de 10 a 14 días después después de la vacunación para generar anticuerpos, que serían necesarios para causar trombocitopenia inmunitaria, explicó la doctora Cindy Neunert, hematóloga pediátrica del Centro Médico Irving de la Universidad de Columbia, en la ciudad de Nueva York.
En la mayoría de los casos, la causa de la trombocitopenia nunca se conoce, agregó el doctor Deepak Bhatt, director ejecutivo de programas cardiovasculares intervencionistas del Brigham and Women’s Hospital en Boston.
En raras, ocasiones, la trombocitopenia inmune está relacionada con ciertas vacunas, con aproximadamente 26 casos por cada millón de dosis de la vacuna contra el sarampión, las paperas y la rubéola.
Pero también puede ser causada por los propios virus, incluido el sarampión y el nuevo coronavirus, dijo el doctor Sven Olson, profesor asistente de hematología y oncología médica en la Escuela de Medicina de la Universidad de Salud y Ciencias de Oregon.
Muchos pacientes con trombocitopenia inmunitaria ahora se preguntan si deberían vacunarse contra covid, dijo Cuker.
Cuker dijo que insta a los pacientes ansiosos a que se vacunen, y señaló que cualquier problema podría manejarse monitoreando de cerca sus niveles de plaquetas y, si es necesario, ajustando la medicación.
Incluso en pacientes con afecciones hemorrágicas subyacentes, “sigue siendo más seguro vacunarse que contraer covid”, dijo Zehnder.
“Si administras una vacuna a un número suficientemente grande de personas, habrá eventos adversos raros, pero también habrá eventos que coinciden temporalmente, pero que no están relacionados con la vacuna”, dijo Cuker.
“Si un grupo antivacunas utiliza un solo caso, donde no se ha demostrado ningún vínculo, para disuadir a las personas de vacunarse, es terrible”.
Barbara Loe Fisher, presidenta del Centro Nacional de Información sobre Vacunas, dijo que su sitio brinda información equilibrada de fuentes de noticias de renombre, como CNN, CBS y el Miami Herald, así como Pfizer y los CDC.
En una entrevista con KHN, Kennedy dijo que cuestiona por qué los funcionarios del gobierno se han apresurado a descartar las conexiones entre las vacunas y las muertes.
“No desanimamos a nadie a que se vacune”, dijo Kennedy. “Todo lo que estamos haciendo es transmitir los datos, que es lo que debería hacer el gobierno. Imprimimos la verdad, que es lo que deberían hacer las agencias médicas”.
Los opositores a la vacunación han minimizado las preocupaciones sobre el nuevo coronavirus durante meses, oponiéndose a las máscaras y luchando contra las órdenes de quedarse en casa y el rastreo de contactos, dijo Richard Carpiano, profesor de políticas públicas y sociología en la Universidad de California-Riverside.
“Se han manifestado en contra de todas las medidas de salud pública para controlar la pandemia”, agregó Carpiano. “Han dicho que la salud pública es el enemigo público número 1”.
Recientemente, estos activistas han estado tan ansiosos por desacreditar las inmunizaciones que han culpado a covid por la muerte de personas que están muy vivas.
Los usuarios de las redes sociales editaron selectivamente un video de una enfermera de Tennessee, Tiffany Dover, para que pareciera que cayó muerta después de vacunarse, cuando en realidad simplemente se desmayó, dijo Dorit Reiss, profesora de la Escuela de Derecho de UC Hastings en San Francisco.
Aunque Dover se recuperó rápidamente, los usuarios publicaron en las redes sociales un certificado de defunción y un obituario falsos. Los activistas antivacunas también acosaron a Dover y a su familia por internet, dijo Reiss, quien relató la terrible experiencia en un blog.
Los activistas contra las vacunas son expertos en manipular videos, dijo Smith.
“Son conocidos por usar videos e imágenes que supuestamente muestran los efectos adversos de las vacunas, como el autismo en los niños y las convulsiones en otros receptores”, agregó Smith. “Cuanto más emotivos y gráficos sean los videos y las imágenes, independientemente de si están realmente vinculados a las vacunas o no, mejor”.
En diciembre, varias publicaciones de Facebook afirmaron falsamente que una enfermera de Alabama había muerto después de recibir una de las primeras dosis del estado. Un usuario de Twitter llegó a identificar a la enfermera como Jennifer McClung, quien trabajaba en el Hospital Helen Keller en Sheffield, Alabama.
De hecho, McClung murió de covid. Las publicaciones en las redes sociales se compartieron tanto que los funcionarios del Departamento de Salud de Alabama se comunicaron con todos los hospitales del estado para confirmar que ningún miembro del personal vacunado había muerto.
Los grupos anti vacunas a menudo construyen fábulas en torno a “una minúscula partícula de verdad”, dijo Smith. “Es por eso que la información errónea, específicamente la información errónea sobre vacunas, puede ser tan convincente… Pero esta información casi siempre se toma completamente fuera de contexto, lo que genera afirmaciones que son engañosas o completamente falsas”.
El Instituto Ron Paul para la Paz y la Prosperidad tergiversó una noticia sobre la muerte de 24 personas en un hogar de adultos mayores en el norte del estado de Nueva York, culpando incorrectamente a las vacunas para covid.
Sin embargo, el artículo original señaló que este hogar había sufrido un brote de covid a fines de diciembre, antes de que los residentes recibieran alguna vacuna. Las vacunas, que requieren dos dosis para una protección completa, no llegaron a tiempo para salvar la vida de los seniors.
En su blog, Kennedy repitió la información errónea, culpando incorrectamente de las muertes de los residentes a las vacunas.
Distorsionar los hechos para desalentar la vacunación es “muy irresponsable y perjudicial para la salud pública”, expresó Cuker.
USE OUR CONTENT
This story can be republished for free (details).
Merck & Co is to axe development of two COVID-19 vaccine candidates, focusing on development of two therapies instead following disappointing results in early trials.
US-based Merck & Co said the decision followed findings from phase 1 clinical studies of the vaccines codenamed V590 and V591.
The company – known as MSD outside North America – said that although the vaccines were well tolerated, the immune responses seen were weaker than natural immunity and those reported for other SARS-CoV-2 vaccines.
The World Health Organization’s regularly updated vaccine tracking webpage says there are 64 vaccines in clinical development, with several approved or close to the market.
With such tough competition, Merck made an easy call following the poor results and has decided to focus instead on advancing two therapies for COVID-19, MK-7110 and MK-4482 (molnupiravir).
The company is also continuing research into a measles-virus vector, which was added to its pipeline following its takeover of Themis last year.
It is also continuing to look at the vesicular stomatitis virus vector-based technology it developed in partnership with the not-for-profit International AIDS Vaccine Initiative (IAVI).
The company was more upbeat about the prospects for its two therapies, however.
MK-7110 (formerly CD24Fc) is a potentially first-in-class investigational recombinant fusion protein that modulates the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint.
Interim results from a phase 3 study showed a greater than 50% reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Full results from this study are expected in the first quarter of 2021.
In December, Merck announced a supply agreement with the U.S. government to advance the manufacturing and initial distribution of MK-7110.
Molnupiravir is being developed in collaboration with Ridgeback Bio and is an oral novel investigational antiviral agent in phase 2/3 clinical trials in both hospital and outpatient settings.
The phase 2/3 study is expected to be completed by May and the first efficacy data could be published in the first quarter if Merck deems it to be “clinically meaningful”.
Merck and its collaborators plan to submit the results of the phase 1 studies for V590 and V591 for publication in a peer-reviewed journal.
The post US Merck axes two COVID-19 vaccines, focuses on therapies instead appeared first on .
Pero existe mano de obra altamente calificada de médicos, enfermeras y otros trabajadores de salud, con formación en el extranjero, que no se aprovecha debido a las dificultades para la obtención de licencias y credenciales.
Según el Migrant Policy Institute de Washington D.C., unos 165,000 inmigrantes formados en el extranjero, que ya están en los Estados Unidos, tienen títulos en campos relacionados con la salud, pero están desempleados o subempleados en medio de la crisis.
Muchos de estos trabajadores cuentan con una enorme experiencia en epidemias, como el SARS, el Ébola o el VIH, en otros países, pero deben permanecer al margen de la pandemia de covid.
La pandemia pone de manifiesto las barreras para la concesión de licencias que ya existían, pero muchos creen que puede servir de llamada de atención para que las legislaturas estatales aborden la cuestión para esta crisis y las que vengan.
Ya hay cinco estados —Colorado, Massachusetts, Nevada, Nueva Jersey y Nueva York— que han adaptado sus normativas de concesión de licencias para permitir que los profesionales de salud, con formación internacional, presten sus servicios durante la crisis de personal provocada por la pandemia.
“Hay taxistas, dependientes, personas que pasean a tu perro, que también son médicos y enfermeros en sus países de origen, y no pueden integrarse en el sistema tal y como está establecido”, dijo Jina Krause-Vilmar, CEO de Upwardly Global, una organización sin fines de lucro que ayuda a los profesionales inmigrantes a incorporarse al mercado laboral.
Médicos como Sussy Obando, inmigrante colombiana de 29 años, tuvo que sortear todo tipo de trabas para que Estados Unidos le reconociera su título. En 2013, se graduó de seis años de la escuela de medicina en Colombia, y pasó un año tratando a pacientes en comunidades desatendidas. Pero cuando Obando llegó a los Estados Unidos, sus credenciales y experiencia no fueron suficientes.
Aunque las normativas para la obtención de estas certificaciones difieren de un estado a otro, los médicos formados en el extranjero suelen tener que aprobar un examen de licencia médica que cuesta más de $3,500 y, a continuación, completar al menos un año de formación en el puesto de trabajo, lo que en Estados Unidos se conoce como residencia.
Para muchos, incluida Obando, eso significa aprender inglés y la terminología médica pertinente. También se necesita experiencia clínica en los Estados Unidos para poder optar a una residencia, algo que los médicos formados aquí consiguen mediante rotaciones durante la carrera de medicina.
“Si no conoces a nadie en este campo, tienes que ir de puerta en puerta para encontrar a alguien que te dé la oportunidad de hacer rotaciones clínicas”, explicó Obando.
Envió correos electrónicos a los médicos hispanos que encontró en internet para ver si podía hacer una rotación clínica con uno de ellos. Acabó pagando para hacer una rotación de psiquiatría en la Facultad de Medicina McGovern de la Universidad de Texas, en Houston.
“Intenté dedicarme a la medicina interna”, contó Obando. “Pero como la psiquiatría era menos costosa, tuve que optar por eso”.
También trabajó durante casi un año como voluntaria en el Centro Oncológico MD Anderson de Texas, y ahora colabora en los ensayos clínicos de las vacunas contra covid en el Centro de Desarrollo de Medicamentos de Texas.
Ha solicitado una residencia a través de un programa nacional que pone en contacto a los graduados de las facultades de medicina con las plazas de residencia. Pero es difícil conseguir una plaza para los médicos formados en el extranjero, porque muchas están destinadas a graduados de las facultades de medicina estadounidenses. Y muchos programas de residencia sólo están abiertos a los recién licenciados, no a los médicos que llevan años ejerciendo en sus países de origen.
“Es competitivo para la gente que se ha formado en Estados Unidos acceder a un programa de residencia”, señaló Jacki Esposito de World Education Services, una organización sin fines de lucro que ayuda a los inmigrantes a encontrar trabajo. “Si te has formado fuera de Estados Unidos, es aún más difícil”.
Por eso, estados como Colorado han suavizado el requisito de residencia durante la emergencia declarada por covid.
Gracias a una orden ejecutiva del gobernador demócrata, Jared Polis, en abril, los funcionarios estatales crearon un programa de licencias temporales, permitiendo a los médicos comenzar a ejercer bajo supervisión durante seis meses, y luego lo extendieron hasta junio de 2021.
Los funcionarios crearon una vía similar hacia la licencia temporal para los graduados de escuelas de medicina internacionales que carecían del año mínimo de formación en residencia.
Colorado también creó licencias temporales para enfermeras formadas en el extranjero, auxiliares de enfermería certificados, asistentes médicos y muchos otros profesionales de salud. Todas estas licencias requieren la supervisión de un profesional autorizado y sólo son válidas mientras siga vigente la declaración de emergencia de salud pública del gobernador.
El estado relajó también las reglas para esos trabajadores de la salud, permitiéndoles realizar cualquier tarea que les asignen sus supervisores.
“Así que, si eres un terapeuta ocupacional, puedes administrar vacunas siempre que te lo asignen y estén seguros de que tienes la capacidad y el conocimiento”, indicó Karen McGovern, subdirectora de asuntos legales de la división de profesiones y ocupaciones del Departamento de Agencias Reguladoras de Colorado. “Durante la pandemia, un profesional puede ir más allá de su especialidad para ayudar en lo que pueda ser útil”.
Hasta mediados de diciembre, el estado había recibido 36 solicitudes de médicos formados en el extranjero que querían obtener licencias temporales, aunque sólo un solicitante ha cumplido todos los criterios hasta ahora.
Nueva Jersey, por su parte, recibió más de 1,100 solicitudes de licencias médicas temporales el año pasado. (Michigan también emitió una orden ejecutiva que permitía las licencias temporales, pero posteriormente fue anulada).
Muchos de los profesionales médicos que se han quedado al margen tienen habilidades y experiencia únicas que serían inestimables durante la pandemia. Victor Ladele, de 44 años, terminó la carrera de medicina en Nigeria y trató a pacientes durante una sequía en Níger en 2005, en medio del genocidio de Darfur en Sudán Occidental en 2007 y tras una guerra civil en Liberia en 2010.
Su familia se trasladó a Estados Unidos unos años después, pero Ladele fue reclutado para ayudar en el brote de ébola en África Occidental en 2014. Lo que pensó que sería una estancia de tres meses se convirtió en una misión de dos años.
Ahora, de vuelta en Edmond, Oklahoma, trabajando en un programa de la ONU que ayuda a nuevas empresas, Ladele ha descubierto que los retos de esta pandemia son parecidos a muchas de sus experiencias del pasado.
Ha visto cómo un programa de localización de contactos de ébola indicaba a las personas con tos o fiebre que llamaran a una línea de atención telefónica, y de ahí se los enviaba a un centro de salud.
Pero tan pronto como se puso en marcha la iniciativa, empezaron a correr rumores en las redes sociales de que los médicos europeos de los centros traficaban con órganos. Hicieron falta meses de contacto con los líderes tribales y religiosos de África Occidental para restablecer la confianza en el sistema.
También fue testigo de cómo se difundía información falsa sobre covid y las mascarillas durante la pandemia.
“Si en Oklahoma, los funcionarios de salud pública hubieran hecho una labor de divulgación entre los pastores de las iglesias y hubieran obtenido su apoyo para el uso de mascarillas, habría más gente usándolas”, aseguró Ladele.
Lo ideal para Ladele sería dedicar la mitad de su tiempo a atender pacientes, pero el proceso de concesión de licencias sigue siendo un reto.
“No es insuperable”, dijo. “Pero cuando pienso en todos los obstáculos para obtener la credencial aquí, no estoy seguro de que merezca la pena el esfuerzo”.
Upwardly Global, una organización sin fines de lucro con sede en Nueva York ha ayudado a profesionales de salud a navegar el sistema de solicitud y obtención de credenciales. Muchos profesionales formados en el extranjero nunca han tenido que redactar currículos o hacer entrevistas de trabajo.
Aunque la pandemia ha facilitado la entrada en unos pocos estados de forma temporal, Krause-Vilmar cree que podría ser un modelo para abordar la escasez de personal en zonas desatendidas de todo el país.
Hasta septiembre de 2020, la Administración Federal de Recursos y Servicios de Salud ha designado más de 7,300 zonas con escasez de personal donde se necesitan 15,000 profesionales de salud adicionales.
“Llevamos mucho tiempo con una crisis de acceso a la salud, especialmente en las zonas rurales del país”, señaló. “¿Por qué no empezamos a pensar en un futuro con más licencias permanentes para esta gente que nos está ayudando a recuperarnos y a reconstruir?”.
USE OUR CONTENT
This story can be republished for free (details).
- The companies sign a purchase agreement with Covax to supply 40M doses of the COVID-19 vaccine. First deliveries are expected in Q1’ 2021, subject to the execution of supply agreements under the Covax Facility structure
- Covax includes an Advanced Market Commitment (AMC) financial mechanism under which Pfizer and BioNTech will provide access COVID-19 vaccines at a not-for-profit price in 92 countries
- The Pfizer-BioNTech COVID-19 Vaccine has been authorized from EUA for active immunization to prevent COVID-19 in individuals 16 years of age and older
Click here to read full press release/ article | Ref: Businesswire | Image: Week
The post Pfizer and BioNTech Signs an Agreement with Covax for Advance Purchase of Vaccine to Help Combat COVID-19 first appeared on PharmaShots.
- The companies sign a purchase agreement with Covax to supply 40M doses of the COVID-19 vaccine. First deliveries are expected in Q1’ 2021, subject to the execution of supply agreements under the Covax Facility structure
- Covax includes an Advanced Market Commitment (AMC) financial mechanism under which Pfizer and BioNTech will provide access COVID-19 vaccines at a not-for-profit price in 92 countries
- The Pfizer-BioNTech COVID-19 Vaccine has been authorized from EUA for active immunization to prevent COVID-19 in individuals 16 years of age and older
Click here to read full press release/ article | Ref: Businesswire | Image: Week
The post Pfizer and BioNTech Signs an Agreement with Covax for Advance Purchase of Vaccine to Help Combat COVID-19 first appeared on PharmaShots.
In some cases, anti-vaccine activists are fabricating stories of deaths that never occurred.
“This is exactly what anti-vaccine groups do,” said Dr. Peter Hotez, an infectious diseases specialist and author of “Preventing the Next Pandemic: Vaccine Diplomacy in a Time of Anti-Science.”
Anti-vaccine groups have falsely claimed for decades that childhood vaccines cause autism, weaving fantastic conspiracy theories involving government, Big Business and the media.
Now, the same groups are blaming patients’ coincidental medical problems on covid shots, even when it’s clear that age or underlying health conditions are to blame, Hotez said. “They will sensationalize anything that happens after someone gets a vaccine and attribute it to the vaccine,” Hotez said.
As more seniors receive their first covid shots, many will inevitably suffer from unrelated heart attacks, strokes and other serious medical problems — not because of the vaccine but, rather, their age and declining health, said epidemiologist Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy.
For example, in a group of 10 million people — about the number of Americans who have been vaccinated so far — nearly 800 people ages 55 to 64 typically die of heart attacks or coronary disease in one week, Osterholm said. Public health officials “are not ready” for the onslaught of news and social media stories to come, he cautioned.
“The media will write a story that John Doe got his vaccine at 8 a.m. and at 4 p.m. he had a heart attack,” Osterholm said on his weekly podcast. “They will make assumptions that it’s cause and effect.”
Public health officials need to do a better job communicating the risks — real and imagined — from vaccines, said Osterholm, who has been advising President Joe Biden on the pandemic since his election.
“You get one chance to make a first impression,” Osterholm said. “Even if we come back later and say, “No, [the deaths] had nothing to do with vaccination, it was coronary artery disease,’ the damage has already been done.”
Anti-vaccine groups such as the National Vaccine Information Center and Children’s Health Defense, founded by Robert F. Kennedy Jr., are already inflaming fears about a handful of deaths — mostly in Europe — that have followed the worldwide rollout of immunizations.
In a blog post, Kennedy scoffed at autopsy results that concluded a Portuguese woman’s death was unrelated to a vaccine. He cast doubt on statements by medical authorities in Denmark who said the deaths of two people there after vaccination were due to old age and chronic lung disease. In an interview, Kennedy said the post-vaccination deaths of some very frail and terminally ill nursing home patients in Norway are a danger sign. Norwegian officials have said the elderly patients died of their underlying illnesses, not from the vaccine.
“Coincidence is turning out to be quite lethal to COVID vaccine recipients,” Kennedy wrote. Kennedy described the deaths as suspicious, accusing medical officials of following an “all-too-familiar vaccine propaganda playbook” and “strategic chicanery.”
Here in the U.S., vaccine opponents have pounced on the tragedy of Dr. Gregory Michael, a 56-year-old Florida obstetrician-gynecologist, to sow doubts about vaccine safety and government oversight. Michael died Jan. 5 after suffering a catastrophic drop in platelets — elements in the blood that control bleeding — suggesting he may have developed immune thrombocytopenia..
According to a Facebook post by his wife, Heidi Neckelmann, doctors tried a variety of treatments to save her husband, but none worked.
A spokesperson for the Centers for Disease Control and Prevention said the agency is investigating Michael’s death, as it does for all suspected vaccine-related health problems. California authorities have recommended pausing vaccinations with a particular batch of covid vaccines made by Moderna because of a high rate of allergic reactions.
“We’re going to see these events happen, and we have to follow up on every one of these cases,” Osterholm said. “I don’t want people to think that we’re sweeping them under the rug.”
Many Americans were already nervous about covid vaccines, with 27% saying they “probably or definitely” would not get a shot, even if the shots were free and deemed safe by scientists, according to a December survey by KFF. (KHN is an editorially independent program of KFF.)
These people may be particularly susceptible to vaccine misinformation, said Rory Smith, an investigator at First Draft News, a nonprofit that reports on misinformation online.
A Rare Condition
Seven experts in blood disorders interviewed by KHN said there’s not enough information available to blame Michael’s decline on a vaccine and that the demonstrated benefits of covid vaccinations vastly outweigh any potential risk of bleeding. Even if investigators conclude that Michael’s vaccine caused his death, it would still be an incredibly rare event, given that more than 12 million doses have been administered.
“It shouldn’t give anyone pause about whether the vaccine is safe or not,” said Dr. James Zehnder, a hematologist and director of clinical pathology at Stanford Medicine.
Michael’s bleeding disorder could have been developing silently for some time, said Dr. Adam Cuker, director of the Penn Blood Disorders Center at the Hospital of the University of Pennsylvania. It could be a coincidence that Michael started showing symptoms shortly after vaccination, he said. About 30 Americans are diagnosed with immune thrombocytopenia every day.
The timing of Michael’s illness suggests it had another cause, doctors said. According to his wife’s Facebook post, his bleeding problems began three days after his first covid shot. It takes the body 10 to 14 days after vaccination to generate antibodies, which would be needed to cause immune thrombocytopenia, said Dr. Cindy Neunert, a pediatric hematologist at the Columbia University Irving Medical Center in New York City.
In most cases, the cause of thrombocytopenia is never known, said Dr. Deepak Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital in Boston.
Immune thrombocytopenia is linked, rarely, to certain vaccines, with about 26 cases for every 1 million doses of measles-mumps-rubella vaccine.
But it can also be caused by viruses themselves, including measles and the novel coronavirus, said Dr. Sven Olson, an assistant professor of hematology-medical oncology at Oregon Health & Science University’s school of medicine.
Many patients with immune thrombocytopenia are now wondering if they should be vaccinated against covid, Cuker said. Cuker said he urges nervous patients to be vaccinated, noting that any problems could be managed by closely monitoring their platelet levels and adjusting medication if needed.
Even in patients with underlying bleeding conditions, “it’s still safer to get vaccinated than to get covid,” Zehnder said.
“If you give a vaccine to a large enough number of people, there are going to be rare adverse events but there are also going to be coincidental events unrelated to the vaccine,” Cuker said. “If an anti-vaccine group uses a single case, where no link has been proven, to discourage people from vaccination, that’s terrible.”
Barbara Loe Fisher, president of the National Vaccine Information Center, said her site provides balanced information from reputable news sources, including CNN, CBS and the Miami Herald, as well as Pfizer and the CDC.
In an interview with KHN, Kennedy said he questions why government officials have been so quick to dismiss connections between vaccinations and deaths. “How in the world do they know if it’s a vaccine injury or not?” he asked.
“We don’t discourage anybody from getting vaccinated,” Kennedy said. “All we’re doing is conveying the data, which is what the government should be doing. … We print the truth, which is what the medical agencies ought to do.”
Opponents of vaccination have belittled concerns about the novel coronavirus for months, opposing masks and fighting stay-at-home orders and contact tracing, said Richard Carpiano, a professor of public policy and sociology at the University of California-Riverside.
“They have come out against every public health measure to control the pandemic,” Carpiano said. “They have said public health is public enemy No. 1.”
Recently, anti-vaccine activists have been so eager to discredit immunizations that they have blamed covid for the deaths of people who are very much alive.
Social media users selectively edited a video of a Tennessee nurse, Tiffany Dover to make it appear as if she dropped dead after being vaccinated, when in fact she simply fainted, said Dorit Reiss, a professor at the UC Hastings College of Law in San Francisco. Although Dover quickly recovered, social media users posted a fake death certificate and obituary. Anti-vaccine activists also harassed Dover and her family online, said Reiss, who chronicled Dover’s ordeal in a blog post.
Anti-vaccine activists are adept at manipulating video, Smith said.
“They are notorious for using videos and images purportedly showing the adverse effects of vaccines, such as autism in children and seizures in other vaccine recipients,” Smith said. “The more emotive and graphic the videos and images — irrespective of whether it’s actually linked at all to vaccines or not — the better.”
In December, multiple Facebook posts falsely claimed that an Alabama nurse died after receiving one of the state’s first covid vaccines. One Twitter user went so far as to identify the nurse as Jennifer McClung, who worked at Helen Keller Hospital in Sheffield, Alabama. In fact, McClung died of covid. Social media posts spread so widely that Alabama health department officials contacted every hospital in the state to confirm that no vaccinated staff member had died.
Anti-vaccine groups often build fables around “a tiny, tiny grain of truth,” Smith said. “This is why misinformation, specifically vaccine misinformation, can be so convincing. … But this information is almost always taken completely out of context, creating claims that are either misleading or outright false.”
The Ron Paul Institute for Peace and Prosperity twisted a news story about the deaths of 24 people at an upstate New York nursing home, incorrectly blaming their deaths on covid vaccinations. The original article noted, however, that a covid outbreak at the nursing home began in late December, before residents received any vaccines. Covid vaccines, which require two doses for full protection, did not arrive in time to save the residents’ lives.
Distorting facts to discourage vaccination, Cuker said, is “very irresponsible and damaging to public health.”
USE OUR CONTENT
This story can be republished for free (details).
Use Our Content
It can be republished for free.
As hospitals nationwide struggle with the latest covid-19 surge, it’s not so much beds or ventilators in short supply. It’s the people to care for the sick.
Yet a large, highly skilled workforce of foreign-educated doctors, nurses and other health practitioners is going largely untapped due to licensing and credentialing barriers. According to the Migration Policy Institute think tank in Washington, D.C., some 165,000 foreign-trained immigrants in the U.S. hold degrees in health-related fields but are unemployed or underemployed in the midst of the health crisis.
Many of these workers have invaluable experience dealing with infectious disease epidemics such as SARS, Ebola or HIV in other countries yet must sit out the covid pandemic.
The pandemic highlights licensing barriers that predate covid, but many believe it can serve as a wake-up call for state legislatures to address the issue for this crisis and beyond. Already, five states — Colorado, Massachusetts, Nevada, New Jersey and New York — have adapted their licensing guidelines to allow foreign-trained health care workers to lend their lifesaving skills amid pandemic-induced staff shortages.
“These really are the cabdrivers, the clerks, the people who walk your dog,” said Jina Krause-Vilmar, CEO of Upwardly Global, a nonprofit that helps immigrant professionals enter the U.S. workforce. “They also happen to be doctors and nurses in their home countries, and they’re just not able to plug and play into the system as it’s set up.”
That’s left doctors such as Sussy Obando, a 29-year-old from Colombia, jumping through hoops to become physicians in the U.S. In 2013, she graduated after six years of medical school in Colombia, then spent a year treating patients in underserved communities. But when Obando arrived in the U.S., her credentials and experience weren’t enough.
While licensure guidelines vary by state, foreign-trained doctors typically must pass a medical licensing exam costing more than $3,500, and then complete at least a year of on-the-job training, known as a residency, in the U.S. For many, including Obando, that means brushing up on their English and learning the relevant medical terminology. She also needed U.S. clinical experience to qualify for a residency, something U.S.-trained doctors achieve through rotations during medical school.
“If you don’t know anyone in this field, you have to go door to door to find somebody to give you the opportunity to rotate,” Obando said.
She tried emailing Hispanic doctors she found online to ask if she could complete a rotation with one of them. She ended up paying $750 to enter a psychiatry rotation at the University of Texas McGovern Medical School in Houston.
“I tried to go into internal medicine,” Obando said. “But because psychiatry was less expensive, I have to go for that.”
She also worked for almost a year as a volunteer at Houston’s MD Anderson Cancer Center, and is now assisting with clinical trials for covid vaccines at the Texas Center for Drug Development. She’s applied for a residency through a national program that matches medical school graduates with residency slots. But it’s difficult for foreign-trained physicians to secure a spot, because many are earmarked for U.S. med school graduates. And many residency programs are open only to recent graduates, not those who finished medical school years ago.
“It’s competitive for people who trained in the United States to get into a residency program. If you’re trained outside the United States, it’s even harder,” said Jacki Esposito, director of U.S. policy and advocacy for World Education Services, a nonprofit that helps immigrants find jobs in the U.S. and Canada.
That’s why states such as Colorado have eased the requirement for a residency during the pandemic. Early on, Colorado officials realized they couldn’t license doctors and other health workers because covid lockdowns had canceled required licensing exams. Under an executive order from Democratic Gov. Jared Polis in April, state officials created a temporary licensing program allowing medical school graduates to begin practicing under supervision for six months, and then extended it through June 2021.
Officials created a similar pathway to temporary licensure for foreign medical school graduates who lacked the minimum year of residency.
Colorado also created temporary licenses for foreign-trained nurses, certified nurse’s aides, physician assistants and many other health professionals. All of those licenses require supervision from a licensed professional and are valid only as long as the governor’s public health emergency declaration remains in effect.
The state relaxed the scope-of-practice rules for those health workers, too, allowing them to perform any task their supervisors assign to them.
“So if you’re an occupational therapist, you can give vaccinations as long as they are delegating to you and they’re confident you have the skill and knowledge,” said Karen McGovern, deputy director of legal affairs for the professions and occupations division at the Colorado Department of Regulatory Agencies. “You can exceed your statutory skill and practice to what needs to be done during the pandemic.”
Through mid-December, the state had received 36 applications from foreign-trained doctors seeking temporary licenses, although only one applicant met all the criteria. New Jersey, on the other hand, received more than 1,100 applications for temporary medical licenses last year. (Michigan also issued an executive order allowing temporary licenses, but it was later rescinded.)
Many of the medical professionals stuck on the sidelines have unique skills and experience that would be invaluable during the pandemic. Victor Ladele, 44, finished medical school in Nigeria and treated patients during a drought in Niger in 2005, in the midst of the Darfur genocide in Sudan in 2007 and after a civil war in Liberia in 2010. His family moved to the U.S. a few years later, but Ladele was recruited to help with the Ebola outbreak in West Africa in 2014. What he thought would be a three-month stay turned into a two-year mission.
Now back in Edmond, Oklahoma, working with a U.N. program that helps new business ventures get off the ground, Ladele has found that the challenges of the covid pandemic parallel many of his past experiences. He saw how a program for Ebola contact tracing told people with a cough or fever to call a hotline, which would direct them to a care center. But as soon as the initiative went live, rumors began to spread on social media that European doctors at the care centers were harvesting organs. It took months of outreach to tribal and religious leaders to instill confidence in the system.
He’s seen similar misinformation spread about covid and masks.
“If, in Oklahoma, the public health officials had done outreach to all the pastors in the churches and gained their support for masking, would there be more people using masks?” Ladele said.
Ideally, he said, he would like to spend about half his time seeing patients, but the licensing process remains a challenge.
“It’s not unsurmountable,” he said. But “when I think of all the hurdles to credentialing here, I’m not really sure it’s worth the effort.”
Upwardly Global helps health professionals navigate that unfamiliar application and credentialing system. Many foreign-trained health workers have never had to write résumés or interview for jobs.
While the pandemic has temporarily eased entry in five states, Krause-Vilmar and others believe it could be a model to address workforce shortages in underserved areas across the country. As of September, the federal Health Resources and Services Administration had designated more than 7,300 health care shortage areas, requiring an additional 15,000 health care practitioners.
“We’ve had a crisis in access to health care, especially in rural areas, in this country for a long time,” she said. “How do we start imagining what that would look like in terms of more permanent licenses for these folks who are helping us recover and rebuild?”
USE OUR CONTENT
This story can be republished for free (details).
California Gov. Gavin Newsom, under growing pressure to jump-start a faltering covid-19 vaccine rollout, jetted to Los Angeles on Jan. 15 to unveil a massive new vaccination site at Dodger Stadium that is expected eventually to inoculate 12,000 people a day.
The city-run venue had been the biggest covid testing site in the U.S., administering over 1 million tests in its nearly eight months of operation — and over 10,000 a day during the recent surge. Its redeployment to the cause of vaccination, Newsom declared, provides “an extraordinary world-class site for a world-class logistics operation.”
That effort came with a trade-off: When the city of Los Angeles ended covid tests at Dodger Stadium and closed another testing site to help staff the new vaccination center, it removed, at least temporarily, about one-third of all government-run testing in Los Angeles County — the nation’s largest county, with a population of 10 million, and one of the biggest covid hot spots.
Sites operated by the city, county or state account for just over one-third of all covid tests in L.A. County, said Dr. Clemens Hong, who heads the county’s testing operations.
Diminished testing capacity could lead to longer waits for appointments, which means infected people could potentially expose others for a longer time before learning they have the virus.
But L.A. Mayor Eric Garcetti said that has not happened so far. In what he called an instance of “perfect timing,” infection rates in L.A. County have declined since Dodger Stadium switched to vaccinations, and demand for tests has dropped by half to two-thirds, the mayor said Thursday. “We are meeting the need — actually exceeding the need.”
Still, he acknowledged that converting the stadium had been a risk – one the city took because “the vaccines will prevent and heal and finally resolve this.”
Many health experts agree that prioritizing vaccination over testing is the right move.
“The best way out of our current crisis is masks, few contacts per day and vaccines, so it makes sense to create lots more access points for vaccinations even if it means a bit less testing,” said Dr. Bob Kocher, a senior fellow at the University of Southern California’s Schaeffer Center for Health Policy & Economics and a former member of the state’s COVID-19 Testing Task Force.
But with covid caseloads still high despite their recent decline from peak levels, and mutant strains of the virus threatening to fuel new outbreaks, some senior public health officials say testing remains an equally vital part of the effort to contain — and ultimately suppress — the pandemic.
And it could become even more important in the coming months, as the inoculation campaign gains steam, since the tests could prove a valuable tool for assessing how well the vaccines are working.
“It’s hard to say right now, given how many people are sick with covid, that vaccine is more important,” said Hong. “It’s hard to balance those two against each other, because we really just need a lot of both.”
Balancing vaccinations with testing and other covid-related tasks is a significant challenge for public health officials across California and the nation, because those functions draw on many of the same resources — especially the staff needed for administration and record-keeping.
At vaccination sites, keeping good records is essential for planning from day to day how many doses to pull out of the freezer. “It’s got to be done right, or else you screw up when the second dose is,” said Dr. George Rutherford, an epidemiologist at the University of California-San Francisco.
Sara Bosse, public health director of Madera County, noted that counties across the state have asked Newsom for $400 million in the current budget year to help defray the costs of setting up vaccination sites, including facility costs, security, data entry staffers and clinicians to give the shots and watch for adverse side effects. They are also seeking $280 million for covid testing and $440 million for contact tracing and non-group housing to protect covid-vulnerable residents.
“I think that many counties are prioritizing vaccination, and based on the resources they have, they may pull from various parts of the covid response such as contact tracing or testing,” Bosse said. The funding, she said, would help county health officials avoid “those difficult decisions where we have to pull from one part of the covid response to prop up the next.”
In Madera County, a poor rural area of 160,000 people that stretches from the Central Valley into the Sierra Nevada, the state has largely taken over covid testing, allowing the county to focus its resources on vaccinations, Bosse said.
The big challenge on that front, she said, is having enough trained health personnel to run the vaccination sites. The county recently heard from 85 trained clinicians willing to volunteer for the vaccine effort, “which is going to be a game changer for us,” Bosse said.
In Los Angeles, the city has the means to add testing capacity elsewhere and beef up mobile testing, Garcetti said. It had been considering a testing site at Pierce College in the San Fernando Valley, “which it looks like we won’t need to open,” the mayor said.
The city, county and state are also discussing the possibility of a partnership to expand testing at Exposition Park in South L.A.
In San Diego County, health officials expect to face a challenge due to the competition for staffing between vaccination and testing, and they are hiring to meet the need, said Sarah Sweeney, a spokesperson for the county’s Health and Human Services Agency. The county hasn’t yet converted testing venues to vaccination sites but expects to do so after vaccine supplies increase, she said.
San Bernardino County health officials are committed to maintaining testing at current volumes even as they ramp up vaccinations, said Corwin Porter, the director of public health. But he conceded that doing both at the same time “is a struggle” because “we don’t have enough vaccine and we don’t have enough staff.”
The county is holding hiring events every week and working with multiple partners to find additional resources, “because we are trying not to pull anything out of testing or contact tracing,” Porter said.
Beyond the resource question, another big challenge confronts health officials: “There is an issue of divided attention,” said L.A. County’s Hong. “Now we have two big things to deal with — three if you include contact tracing. I think we will have to be thoughtful about our strategy.”
Once a broad swath of the population has been vaccinated, which could take many months, testing volume will likely drop off sharply, said UCSF’s Rutherford.
“I don’t see hundreds of thousands of tests a day anymore once we get well up on vaccinations,” he said. “You’ll be testing thousands of people to find tens of cases.”
In the meantime, L.A. County will likely add questions to its testing appointment website asking people about their vaccination status, Hong said. “That way we can track what’s happening in people who are vaccinated.”
Ongoing covid outbreaks may require increased testing, particularly in poorer communities of color, which have been hit hardest by the pandemic — and where hesitancy to be vaccinated is likely to be more widespread, said Hong. “So the bottom line is that testing is not going away.”
USE OUR CONTENT
This story can be republished for free (details).
As Joe Biden takes the reins at the White House, pharmaphorum asks experts how his presidential tenure may influence the global healthcare industry.
“I think the Biden administration will have only an incremental impact on the healthcare industry as a whole,” said Maxim Jacobs, CFA, managing partner and director of research at Edison Group.
“With a slim majority in the House and an evenly divided Senate it will be tough for him to get anything radical through Congress. He ran on protecting and expanding Obamacare and I think that is probably what he will try to do. He’ll be able to protect it but I’m not sure about his ability to expand it or enact things like the public option.”
Given other challenges in the US that need to be dealt with first – such as the COVID-19 response, additional Medicaid funding and economy and tax reform – dramatic changes are unlikely, said Mark Brewer, life sciences research director for finnCap.
“Sweeping healthcare reform, in the way that it was prioritised in the Obama administration, is unlikely to be top of the agenda, partly also due to the narrow majority that the Democrats have in the House of Representatives and the Senate and the time/effort that would be required to try and push through such legislation without any guarantee of success. We don’t believe there will be draconian price cuts, for the same reason.
“The industry should continue to prosper with innovation driving new product introductions and consequently valuations. Post-COVID recovery in global healthcare systems should also drive the broader healthcare sector, which should benefit device companies and those focused on elective surgery rates,” said Brewer.
Biden could put additional scrutiny on drug prices but more drastic measures, such as allowing Medicare to negotiate with pharma companies directly, are still unlikely, according to Tim Xu, investment associate at Boston, US-based Arix Bioscience.
“Policy-wise, President Biden will aim to protect and restore Obamacare, which to many remains a band-aid solution to the US’ healthcare problem. It is quite likely that cornerstones of the Affordable Care Act will be found unconstitutional by the Supreme Court, such as the individual mandate.
“As ever, it takes a “supermajority” of over 60 votes to get any major legislation through the Senate, so longer-term Democratic wishlist items like a public option or single payer are unlikely. What this means for the pharma industry is likely business as usual, at least until the midterm elections in 2022.”
Generic and opioid-alternative companies could benefit from expanded coverage, if Biden changes policy, according to analysts at Jefferies. In the EU, pharmaceutical companies like Roche could have the largest exposure to Medicare Part B drug reforms due to the proportion of its products that are either IV infused or administered in the physician’s office.
“Some of this apparent threat is already de-risked, given biosimilar erosion of Rituxan, Herceptin and Avastin which have wider pricing disparities ex-US than the newer launches at more competitive prices such as Ocrevus, Hemlibra and Tecentriq. Ex-US stocks with less Part B exposure are Novo Nordisk, Novartis and GSK,” said Jefferies’ Peter Welford.
One area where Biden might be able to make a big difference is pandemic preparation, according to Jacobs. “COVID has been a global disaster and unfortunately there are other pathogens that can be as or more deadly. He’ll probably want greater investment in biodefense so the country can increase its stockpile ahead of the next pandemic event, which may increase industry focus on vaccines, antivirals and antibiotics.”
While Donald Trump had a strained relationship with the scientific community, Biden is keen to strengthen its position. This support could help the US preserve its reputation for being at the forefront of research, science and innovation. “It is very clear that Biden is using science and not public opinion to drive change,” ImaginAb CEO, Ian Wilson told pharmaphorum.
“He has publicly stated he expects newly appointed presidential science adviser and the director of the Office of Science and Technology Policy (OSTP), Eric Lander and his team to address questions about the future of science and technology and recommend how his administration can combat public health threats, mitigate the impact of climate change, keep the country a world leader in innovation, use science to improve social equity, and strengthen the US research enterprise.
“This is the first time in history the science adviser will be a cabinet-level position. That, along with the 100 day promise to immunise 100 million people, increased stimulus packages to ensure biotech companies and smaller businesses can ride out the pandemic, and a focus on making the US a leader once again in medical science, gives hope for a new beginning.”
The post Biden administration – What can the healthcare industry expect? appeared first on .
Gilead Sciences says its antiviral Veklury should be effective against the new, more contagious COVID-19 variants discovered in the UK and South Africa.
According to the US biopharma company, genetic analyses of publicly available sequences for the new variants of SARS-CoV-2 suggest the mutations in the viral spike protein that have made them more transmissible shouldn’t affect the way Veklury (remdesivir) works.
The UK strain – known as B.1.1.7 or VOC 202012/01 – has already been reported in dozens of countries around the world and is estimated to be somewhere between 50% and 70% more infectious than the original strain of SARS-CoV-2.
Last week, the Centers for Disease Control and Prevention (CDC) warned of rapid growth of the variant in coming weeks and said it could become the dominant strain in the US within weeks.
The South African variant B.1.351 (also known as 501Y.V2) meanwhile is also spreading around the world and is estimated to be 50% more transmissible.
So far, neither variant seems to be associated with more severe COVID-19 symptoms, although there has been some preliminary research suggesting the SA strain could allow reinfection with SARS-CoV-2, and also be less susceptible to vaccines. This week, Pfizer and BioNTech said their Comirnaty shot seemed to retain efficacy against the UK variant.
“The mutations identified in these new variants have not significantly altered the part of the virus that remdesivir targets or have any association with known mutations conferring reduced susceptibility of coronaviruses to remdesivir in vitro,” said Gilead in its statement.
“We continue to conduct additional research to evaluate newly emerging variants and to further understand their potential impact on remdesivir,” it added.
Veklury is currently the only antiviral drug licensed for the treatment of COVID-19 and works by interfering with a polymerase enzyme central to the production of viral RNA particles.
There has been no evidence of resistance to the drug in SARS-CoV-2, although that was observed in experiments involving Ebola, the viral disease for which it was originally developed.
Scientists have suggested that – theoretically at least – SARS-CoV-2 could see similar changes in polymerase that could reduce Veklury’s efficacy.
The post Gilead says Veklury should work against COVID-19 variants appeared first on .
The ongoing COVID-19 pandemic has affected the routines of many practicing physicians, including an impact on their prescribing decisions. New research from CRA shows that for many physician practices, prescribing has shifted based on route of administration. These changes, initially presumed to be temporary, may continue beyond the pandemic.
As several COVID-19 vaccine candidates progress to patients and with more than 150 other vaccines in clinical development, global communities look forward to returning to “normal life,” but it is also increasingly likely that what we return to will be a “new normal”.
For many practicing physicians, changes presumed to be temporary just a few months ago may in fact become part of more permanent changes to their practice structure. As the COVID-19 pandemic continues, personal protective equipment (PPE) requirements, social distancing, increased telehealth and fewer in-person doctor visits have become common.
Many physicians are also now reporting affordability issues among their patients. In this article, we focus in particular on how COVID-19 may be changing prescribing decisions using market research and claims data.
Together with research partner Dynata, Charles River Associates (CRA) conducted a recent survey of 140 physicians to better understand their perceptions of the pandemic’s effects on their daily practice, including current and potential future changes.
The survey focused on oncologists and neurologists, two specialties that regularly see immunocompromised patients receiving long-term treatment, and also surveyed pulmonologists and urologists to gauge the wider impact on prescribing habits. The findings (both self-reported by physicians and observed in claims) suggest that the pandemic is affecting the therapies that patients receive, as healthcare providers (HCPs) look to reduce the risk of their patients contracting COVID-19.
Analysis of prescribing changes
Based on the survey results, the majority of HCPs (61%), especially oncologists, report changing their prescribing decisions in some way as a result of COVID-19 (see Figure 1). The proportion of physicians who reported changing prescribing decisions varied, ranging from 77% for oncologists to 46% for urologists (pulmonologists and neurologists reported changing their prescribing decisions 54% and 65% of the time, respectively). Ways in which physicians changed their prescribing decisions include:
- Shifting prescribing toward therapies with less frequent dosing (reported most often by oncologists [40%] followed by neurologists [26%])
- Moving toward more established therapies (reported most often by neurologists [37%])
- Moving toward therapies with fewer side effects (reported most often by pulmonologists [26%])
- Most commonly, moving toward therapies that require less in-person contact, such as subcutaneous or oral medicines versus intravenous medicines (reported most often by oncologists [43%] and neurologists [37%])
Figure 1. Changes in Prescribing by Specialty
Source: CRA market research (conducted June 2020)
Each of these changes may offer potential benefits for both HCPs and patients. For example, prescribing more established therapies or therapies with more robust efficacy and safety data may make it easier for HCPs to titrate dosing or manage adverse events. Shifting prescribing toward therapies that require less frequent dosing and less in-person contact (such as moving from an intravenous therapy administered in an infusion centre to a subcutaneous therapy that can be administered conveniently at home) has clear potential benefits as a result of reducing interaction that may spread COVID-19.
There are also special considerations for immunocompromised patients including those with cancer or autoimmune disorders such as multiple sclerosis (MS) who are shown to be at increased risk of complications and death from COVID-19. Given their susceptibility to contracting COVID-19 and its associated complications, oncologists and neurologists may be especially motivated to look for opportunities to reduce the risk to immunocompromised patients, including reducing the amount of in-person contact and hands-on management. Switching to therapeutic options that involve less in-person contact may also be more amenable for patients who feel uncomfortable or have difficulty traveling to an infusion centre safely during the pandemic. Fewer patients coming in and out of an infusion centre may help infusion nurses and other staff to also reduce their potential exposure to COVID-19.
Overview of patient claims data
To further explore the impact of COVID-19 on prescribing decisions among neurologists and oncologists specifically, including the proportion of infused therapies prescribed, CRA worked with data from Compile to analyse claims data from patients with MS and HER2+ breast cancer (see Figure 2). These data cover about 30% of US pharmacy claims and about 50% of US medical claims for these conditions.
More than 100,000 MS patients were included in the data set, defined as patients with two or more MS-related medical claims or one or more MS-related medical claims plus a related pharmacy claim identified between January 2019 and June 2020. Focusing on the subset of MS patients shown to have received treatment from neurologists during this time period, infusion therapies (specifically Lemtrada, Ocrevus, and Tysabri) showed a decline of 19% in terms of the total number of claims from February to June 2020.
Our team also reviewed claims data for more than 280,000 HER2+ breast cancer patients during the same observation period (January 2019 to June 2020) and using the same parameters for claims data (two or more HER2+ breast cancer-related medical claims or one or more HER2+ breast cancer-related medical claims plus a related pharmacy claim). Similar to MS patient data, we observed a marked decrease in use of infusion therapies among the subset of HER2+ breast cancer patients shown to have received treatment from oncologists during the observation period. In fact, the claims data suggest that oncologists may be even more likely to shift away from infused therapies to other routes of administration (such as oral or subcutaneous) compared to neurologists. Among HER2+ breast cancer patients in this claims analysis, there was a significant decline of about 41% in terms of the total number of claims using infusion treatment (including Enhertu, Herceptin, Herzuma, Kadcyla, Ogivri, Perjeta, and Trazimera) from oncologists from February to June 2020.
Figure 2. Changes in Prescribing by Specialty
Source: CRA claims data analysis (using claims through June 2020)
Our analysis represents a preliminary review of the impact of COVID-19 on prescribing habits among physicians including specialists. Given the specialised focus in the analysis and the nature of the data, there are caveats associated with using this data source; these may include under-representation of in-patient claims, limited coverage of certain mail-order channels and specialty pharmacies, and the uncertainty of claims capturing for some patient populations.
Impact on patients
Physicians are also adjusting to the impact of COVID-19 on their patients, including patient anxiety and personal finances. More than half of the surveyed physicians in the market research data reported higher patient anxiety due to COVID-19, and most pulmonologists (77%) and oncologists (66%) also reported that patients often contact them with COVID-19-related concerns or questions. They indicate that financial anxiety is likely exacerbating patient anxiety. Many physicians also reported seeing an increase in issues related to financial difficulties among their patients, such as:
- discontinuing or skipping medications due to cost (45% of physicians)
- no longer being able to afford prescribed medications (41% of physicians)
- losing insurance (e.g. through non-employment) (40% of physicians)
- requesting cheaper medications such as generics (35% of physicians)
As the pandemic’s toll on the economy continues, physicians will likely see themselves having more difficult conversations with their patients surrounding medication management and affordability. Being aware of these trends can help physicians prepare their practices to better address such issues. For example, practices may collaborate with pharmaceutical companies to make it easier to help patients find and enroll in financial support programmes.
Taken together, all findings thus far indicate that COVID-19 may be affecting the way physicians prescribe medication and interact with patients, among other impacts. Based on our survey, physicians also cite likely trends such as increased virtual medical conferences and fewer visits with sales representatives, with both outlets possibly becoming less predominant sources of product development information.
In recognition of potential systemic changes in the delivery and access of healthcare services, physicians will continue to adapt their practices to the new environment to address both internal and patient concerns. This may require education from and communication with pharmaceutical companies and other industry stakeholders moving forward. Acknowledging that temporary changes including prescribing changes may become permanent and preparing for this shift can better position HCPs and their practices to succeed in the post-COVID-19 era.
About the authors
Kristen Backor, PhD, is director of the market research Center of Excellence at CRA, providing guidance and oversight for projects concerning customer insights and qualitative and quantitative research assessments.
Eddie Li is director of the Analytics Center of Excellence at CRA, where he specialises in market assessment, promotional response modelling, customer segmentation and patient finding.
Jing Li is a senior associate in the Analytics Center of Excellence at CRA with significant experience in analysis of pharmaceutical claims data.
Elizabeth Rountree is a vice president at CRA with 20+ years of customer insights experience (data analytics, primary market research) in biopharmaceuticals as well as in-depth expertise in neurology and oncology.
Billy Wang is an associate at CRA who has been helping clients define COVID-19 focused strategies since the beginning of the pandemic.
The views expressed herein are the authors’ and not those of Charles River Associates (CRA) or any of the organisations with which the authors are affiliated.
The post Assessing physician practices and expectations in the post-COVID era appeared first on .
President Biden now faces major challenges in accomplishing his health care agenda; among the biggest will be bridging partisan divides in both Congress and the nation at large.
Even with the Democrats’ newfound majority in the Senate — the result of victories by the Rev. Raphael Warnock and Jon Ossoff in Georgia’s runoff elections — differences in health policy between the party’s moderate and progressive wings will persist.
“With razor-thin Democratic majorities in both the House and the Senate and many other priorities in addition to health care, Biden is unlikely to succeed in accomplishing all of his health agenda,” said Larry Levitt, executive vice president for health policy at the KFF. (KHN is an editorially independent program of KFF.)
Still, Democratic control of the Senate will allow Biden to pursue some of his health care priorities “using a two-pronged strategy of legislation and executive actions,” Levitt said.
PolitiFact and KHN teamed up to analyze Biden’s promises during the 2020 presidential campaign and will monitor his policies over the next four years to see which ones materialize. But, for now, as Biden settles into the West Wing, what are his chances of making progress on health care?
The Covid Pandemic
In his first 100 days in office, Biden has promised to get 100 million doses of covid vaccine in the arms of Americans and — if Congress provides the funds to do so — get all kids back into schools safely. He asked people to wear face masks in public for those 100 days. He also has repeatedly promised he would get the covid pandemic under control.
Other covid promises include a pledge to double the number of drive-thru testing sites and create a national pandemic testing board. He said he wants to invest $25 billion in covid vaccine distribution and to ensure that every American has access to the vaccine at no cost. He’s also promised to use the Defense Production Act to ramp up personal protective equipment supplies and restore national stockpiles.
During his first two days in office, Biden took steps to accomplish these goals, using executive orders to put in place masking mandates regarding federal buildings and interstate travel — for example, in airports and on commercial aircraft, trains, ferries and intercity bus services — and re-engaging the United States with the World Health Organization. He also issued orders to create a covid response coordinator who will lead the federal government’s efforts for providing vaccination, testing and supplies, set up a national pandemic testing board, establish international travel protocols, use the Defense Production Act to provide necessary supplies and ensure minority communities are provided resources to combat the disease. The White House released a 200-page plan on Thursday that outlines the Biden administration’s strategy to address the covid-19 pandemic.
Some members of his covid leadership team — such as Jeff Zients, tapped to coordinate the White House’s covid response, and Dr. Rochelle Walensky, who will lead the Centers for Disease Control and Prevention — don’t require Senate confirmation, meaning they can get to work right away. But Biden’s pick for Health and Human Services secretary, Xavier Becerra, will need approval by the Senate, a step that will likely be eased because of Democrats’ Georgia victories. Still, how his nomination plays out — as well as Biden’s other selections for posts that require confirmation — could be an early sign of whether the new administration will face strong partisan resistance.
While the executive orders are strong signals of what Biden hopes to accomplish, he will need Congress to fund his plans to expand testing and vaccine distribution. Biden outlined the week before his inauguration in a $1.9 trillion proposal to address covid and the economy. However, the president could face difficulty in getting bipartisan agreement on this plan, with some Republicans criticizing it as too expensive. It took Congress seven months to pass a second covid relief bill in December.
Other limiting factors include whether the supply of vaccine is adequate to reach 100 million doses and whether organized efforts are put in place to increase testing and ramp up production, said Dr. Georges Benjamin, executive director of the American Public Health Association.
One area in which Biden could face pushback: mask-wearing. Even though he has already issued executive orders regarding mask use in federal buildings, for instance, broader mask mandates fall under individual governors’ authority, and some Republican state executives remain resistant.
Even if Biden makes inroads on that front, Americans will have to accept this step as part of their daily lives. A December KFF survey showed that while most Americans, regardless of party, wear a mask whenever they leave their house, there is still a lag among Republicans.
“I think Biden’s biggest challenges in fulfilling his covid goals are in bringing a divided country together with the bully pulpit of the presidency,” said Levitt. “If testing and the vaccine and mask-wearing are successful in only blue America, then it will be hard to succeed overall.”
As Barack Obama’s vice president, Biden was instrumental in the enactment of the Affordable Care Act, which expanded health insurance coverage to millions of people but has drawn fierce Republican opposition.
Biden’s health agenda promises to expand the ACA and undo many of the steps taken by President Donald Trump to dismantle it.
“I’ll not only restore Obamacare, I’ll build on it. You can keep your private insurance. If you like it, you can choose a Medicare-like public option,” Biden said during a campaign event in Pittsburgh on Nov. 2.
Adding a government-run public option to other ACA health care plans is one of Biden’s most ambitious pledges. It’s a controversial idea even within the Democratic caucus, where some members want instead to move to a single-payer health plan like “Medicare for All.” Remember the debates during the Democratic presidential primary?
Health policy experts we consulted said implementing a public option seems extremely unlikely in the current environment. So does lowering the Medicare eligibility age from 65 to 60, another divisive idea among Democrats. But both moderates and progressives — even lawmakers across the aisle — might be able to come together on initiatives that could shore up the ACA and make coverage more affordable, such as expanding eligibility for premium subsidies.
Biden doesn’t need Congress to restore parts of the ACA that were changed via regulations issued by the Trump administration. He can instruct agencies to issue new rules that would reverse such Trump initiatives as allowing states to implement work requirements for some adults who gained Medicaid coverage in the ACA expansion of that program. Still, regulatory changes take time. And, in some cases, altering them can be complicated.
Take, for instance, the Trump administration’s rules promoting short-term or association health plans. That metaphorical cat is already out of the bag, said Joseph Antos, a health care scholar at the American Enterprise Institute.
“There are a lot of people insured through those plans and so [changing that policy is] a very tricky thing,” said Antos. “I don’t think it would be wise for him to do anything to reverse that [rule] even though there has been a lot of noise from the left.”
In Antos’ view, the main advantage in gaining Senate control will be helping speed confirmation for key nominations, “which opens the door to new thinking on regulations.”
On the campaign trail, Biden made clear his intent to bring down prescription drug prices. He promised to lower costs by 60%. Among the related policy ideas he floated: repealing the law that bars Medicare from negotiating lower drug prices and allowing the importation of prescription drugs from other countries.
But details of these proposals aren’t yet available, leaving some experts to question their feasibility.
Of course, the pharmaceutical lobby won’t be enthusiastic about any drug pricing legislation and would likely mount an aggressive campaign to defeat it. And just as with any other proposal, there will be the hurdle of getting Congress to agree on what to include in a drug pricing bill. Plus, given the rapid development of covid vaccines, Capitol Hill may be more sympathetic to the drug industry.
But Stacie Dusetzina, an associate professor of health policy at Vanderbilt University, said it’s possible Biden could succeed in lowering drug prices by limiting drug price increases to the rate of inflation and capping out-of-pocket spending for seniors covered by Medicare.
Both the House and Senate included similar proposals in past drug pricing bills, she said, and “those are both things I think could legitimately move forward, if anything moves forward.”
USE OUR CONTENT
This story can be republished for free (details).
- The P-III BLAZE-2 COVID-19 prevention trial involves assessing bamlanivimab (4,200mg) vs PBO in residents and staff at skilled nursing and assisted living facilities. The 965 &132 COVID-19 negative & positive participants were included in the analysis of 1EPS & 2EPs for assessing prevention & in exploratory analyses respectively
- The results demonstrated an 80% reduction in risk of contracting COVID-19 in residents. Results for all 2EPs also reached statistical significance in both the overall and resident populations
- Results from the exploratory analyses showed viral load is consistent with the previous studies
Click here to read full press release/ article | Ref: Lilly | Image: Reuters
Use Our Content
It can be republished for free.
Over a month into a massive vaccination program, most older Americans report they don’t know where or when they can get inoculated for covid-19, according to a poll released Friday.
Nearly 6 in 10 people 65 and older who have not yet gotten a shot said they don’t have enough information about how to get vaccinated, according to the KFF survey. (KHN is an editorially independent program of KFF.)
Older Americans are not the only ones in the dark about the inoculation process. About 55% of essential workers —designated by public health officials as being near the front of the line for vaccinations — also don’t know when they can get the shots, the survey found. Surprisingly, 21% of health workers said they are unsure about when they will get vaccinated.
Black and Hispanic adults, as well as those in low-income households, are among the groups struggling most to find vaccine information. Within each of those groups, at least two-thirds said they do not have enough information about when they can get vaccinated, the survey found.
The covid vaccines, which were first distributed in mid-December to health care workers and people living in nursing homes or assisted living centers, are now available for other older adults in most states, though age restrictions vary. Ohio, for example, opened up vaccinations to all residents 80 and older. In Virginia, the minimum age for the second wave of shots is 65. In Indiana, it’s 70; Maryland, 75. Some states, such as Florida and Texas, started vaccinating anyone 65 and up in December, though many states did not begin vaccinating all seniors until January.
Limited doses have left many seniors scrambling to get an inoculation appointment.
For example, at 9 a.m. Thursday, Washington, D.C., opened 2,200 covid vaccine appointment slots for people 65 and older in several hard-hit neighborhoods. Within 20 minutes, they were all filled.
To date, more than 15 million Americans have been vaccinated for covid, which has infected 24 million and killed more than 400,000. The two covid vaccines authorized for emergency use by the Food and Drug Administration require two doses either three or four weeks apart.
Despite the rocky rollout of vaccines, two-thirds of respondents were “optimistic” that things will get better.
Sixty-five percent of adults said they believe the distribution of the vaccines is being done fairly, but half of Black adults said they were concerned that the efforts are not adequately considering the needs of the Black community.
The KFF survey of 1,563 adults was conducted Jan. 11-18. The margin of sampling error is plus or minus 3 percentage points.
USE OUR CONTENT
This story can be republished for free (details).
President Joe Biden wasted no time getting down to work. Among the raft of executive orders he signed on Inauguration Day were several aimed at curtailing the covid crisis, including one requiring mask-wearing by federal employees and anyone on federal property for the next 100 days.
Meanwhile, with the inauguration of Vice President Kamala Harris and the swearing-in of two new Democratic senators from Georgia, Democrats took over the majority in the Senate, albeit with a 50-50 tie. That leaves Democrats in charge of both the legislative and executive branches for the first time since 2010, but with such narrow majorities it could be difficult to advance many of Biden’s top health agenda items, starting with an expansion of the Affordable Care Act.
This week’s panelists are Julie Rovner of KHN, Alice Miranda Ollstein of Politico, Tami Luhby of CNN and Sarah Karlin-Smith of the Pink Sheet.
Among the takeaways from this week’s podcast:
- Although Biden can make certain changes to the federal policies in the fight against covid-19, much of what he has detailed in his plan will require congressional action, and Senate Republicans do not appear willing to support a major legislative package just yet.
- Many of the efforts against covid that Biden has said he wants to put in place are initiatives that have been recommended by public health officials over the past year and not acted upon. But the discovery of new, more contagious variants of the coronavirus may necessitate faster efforts to distribute vaccine and other actions.
- Wearing masks and other simple public health practices can have a big impact on slowing the spread of covid, but much of the public is looking to a vaccine for help. Those supplies remain limited and it’s not clear whether Biden’s interest in using the Defense Production Act to force industry to help will increase vaccine production.
- Vaccination success is hampered by unreliable estimates of the amount of supplies states can expect to receive and a patchwork of sign-up methods and eligibility criteria.
- Among the actions Biden and a Democratic Congress could take to reverse policies instituted by the Trump administration are ramping up workplace enforcement of covid rules to help keep employees from spreading the disease, restoring a penalty for not having insurance so that the lawsuit threatening the Affordable Care Act would become moot, and overturning rules requiring reviews of federal scientists.
- The Senate has not yet scheduled a confirmation hearing for Xavier Becerra, Biden’s choice for Health and Human Services secretary. Before a mob stormed the U.S. Capitol this month, it was thought that establishing a new federal health team would be the president’s priority, but national security took precedence after the violence.
- Controlling drug prices is an issue with huge popular support, but Congress is divided over how to do it. The broad measure that passed the House in 2019 is again unlikely to fly in the Senate, but senators may try to produce a more modest proposal along the lines of a bipartisan measure offered previously by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore).
- Drugmakers have generally fought most efforts to implement price controls, but there may be growing interest within the industry to work out a bipartisan deal that they have a hand in, rather than waiting to see what Democrats can push through.
Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:
Julie Rovner: The Atlantic’s “Pramila Jayapal Is ‘Next-Level’ Angry,” by Elaine Godfrey
Alice Miranda Ollstein: The New York Times’ “Emerging Coronavirus Variants May Pose Challenges to Vaccines,” by Apoorva Mandavilli
Sarah Karlin-Smith: Vanity Fair’s “A Tsunami of Randoms”: How Trump’s COVID Chaos Drowned the FDA in Junk Science,” by Katherine Eban
Tami Luhby: KHN’s “Black Americans Are Getting Vaccinated at Lower Rates Than White Americans,” by Hannah Recht and Lauren Weber
To hear all our podcasts, click here.
USE OUR CONTENT
This story can be republished for free (details).
Scientists at the Alderley Park Lighthouse Lab in Cheshire have revealed the speed and scale at which the new variant of the COVID virus is spreading through communities across the country.
The Lighthouse, operated by Medicines Discovery Catapult (MDC) and launched last April, plays a key role in the UK Government’s national COVID testing programme. It can process more than 50,000 samples a day and has recently completed its 6 millionth test.
Its scientists have identified the new COVID variant in the lab’s PCR test and have been able to use this new science to track the spread of the new COVID variant across England and Wales.
The ThermoFisher PCR test, used at many of the Lighthouse Lab sites, measures 3 genetic markers of SARS-CoV-2. Lighthouse scientists have shown that the new variant exhibits ‘S-gene dropout’, whereby one of the markers – the S-gene – fails to amplify, but the other two genetic markers (ORF1ab and N) are found, confirming a positive COVID result.
The Lighthouse data shows the rise and geographical distribution of these S-gene target dropout cases from the 1st to the 21st of December 2020. The data shows rapidly increasing numbers of cases of the new variant across London, East-South East, parts of the North West, South West regions and West Midlands.
Areas with the highest incidence in the study correlate with areas now reporting high NHS load and hospitalisation. This dramatic timeline view validates the national level of concern, concurrent with the imposition of the recent lockdown. Ongoing vigilance of the data may also indicate regions that in future will see high infection and hospitalisation rates.
Professor Chris Molloy, CEO of MDC and founding director of the Lighthouse Lab network believes it demonstrates the quality of the science that underpins what is the largest diagnostics project in UK history.
Prof. Chris Molloy, said:
“Today’s high-quality data from the MDC Lighthouse team shows the excellence of its science at a national scale. The Lighthouses are high-powered beacons into the darkness of this disease, combining industrial scientific rigour and close coordination with NHS and PHE in the service of the nation.”
Dr Mark Wigglesworth, Site Director at the Alderley Park Lighthouse Lab and senior author of the report, comments:
“Although the speed of the spread is shocking, we’re working really closely with the government to share our scientific discoveries and advancements, which in-turn informs decision making across the devolved nations, so that we can be in the best position to beat the virus.
“While a new national lockdown is not what anyone would have wanted, our scientists’ work in discovering the spread of the new variant will be pivotal in informing government policy, protecting the NHS and saving lives.”
For more information on the findings, read the paper at medRxiv >
The post Testing Lab Data Reveals Spread of New Covid Variant Across the Country appeared first on .
The state-owned backers of Russia’s Sputnik V coronavirus vaccine have ruled out a US filing, as talks began in earnest with European regulators over a review.
Following a press conference on Thursday morning, the Russian Direct Investment Fund (RDIF), which has been bankrolling the vaccine developed by a team in Moscow, said it had already had enough orders for the vaccine.
RDIF, which is Russia’s sovereign wealth fund, said that with 2.4 billion doses already ordered worldwide, enough for 1.2 billion people, there is no interest in supplying a US market of 328 million people.
“Why should we?” said an RDIF spokesperson when pharmaphorum asked if there were plans to file the vaccine developed by the Gamaleya Research Institute with the FDA.
Supplies of the vaccine are due to begin shipment to Hungary, where the national regulator has independently approved it in a move that has caused tension with the rest of the EU.
The spokesperson’s comments came after CEO Kirill Dmitriev focused on the importance of keeping politics out of the vaccine approval process in today’s briefing.
A major peer-reviewed study of the vaccine is due for publication next week, Dmitriev said, who made the case for the vaccine’s safety, efficacy and easy storage and transport requirements.
Praising regulators that had approved the vaccine so far, such as Hungary and the United Arab Emirates, Dmitriev said: “A non-political approach will save the world. We believe it will be one of the most widely accepted vaccines in the world.”
He also referred to press reports from Israel raising concerns about the efficacy of the initial Pfizer vaccine shot, while claiming that Sputnik V can produce 73% efficacy after its first dose.
To get the shot approved across Europe RDIF must get Sputnik V centrally authorised by the European Medicines Agency (EMA), following guidance announced earlier in the pandemic.
There have already been preliminary “Scientific Advice” talks with the EMA ahead of a potential rolling review beginning next month, although the RDIF gave no further guidance on timelines.
The RDIF is to receive support from the German regulator to get the vaccine reviewed by the EMA, the spokesperson.
Chancellor Angela Merkel said today that Germany’s regulator the Paul Ehrlich Institute, can provide assistance in the process.
The first shot to win the backing of a national regulator last summer, Sputnik V only needs to be stored at conventional refrigerator temperatures instead of the ultra-cool temperatures required to maintain the integrity of delicate mNRA vaccines from Pfizer/BioNTech and Moderna.
Study data so far suggest that at 90% effectiveness it provides protection that is almost on par with the mRNA vaccines, while AstraZeneca’s rival is only 62% effective in its approved formulation.
RDIF was established in 2011 by the Russian government to make investments in leading companies and high-growth sectors of the country’s economy, looking for co-investment from large institutional investors.
The post Russia asks for “non-political” treatment of Sputnik V shot, then rules out US filing appeared first on .
The COVID-19 pandemic has brought healthcare guidelines and scientific advances front-of-mind on a global scale, in the process highlighting long-standing gaps in health literacy as well as an opportunity for pharma.
It’s long been known that many people struggle to access, understand and use health information and services to make decisions about their health.
As the WHO noted in 2013: “Knowledge societies in the 21st century confront a health decision-making paradox. People are increasingly challenged to make healthy lifestyle choices and manage their personal and family journeys through complex environments and health care systems but are not being prepared or supported well in addressing these tasks.”
Just how unprepared people are has been laid bare time after time. According to the 2012 European Health Literacy Survey, 29% to 62% of people across eight EU member states had inadequate or problematic health literacy.
And that’s before national television briefings began on COVID’s ‘R number’, an ever-mutating set of restrictive rules and an evolving understanding of the science behind a novel coronavirus first identified on 7 January 2020.
Alongside COVID’s devastating effects, 2020 also saw a raging misinformation pandemic as fake science and conspiracy theories spread rampantly online, often peddled by those in power, such as the former US president Donald Trump.
A challenge to self-care
The spread of health misinformation at a time when we are increasingly expected to practice self-care wherever possible has been a particularly pernicious modern development and has turbo-charged dangerous ‘anti-vax’ ideas.
Filippo Lanzi is EMEA regional head for GSK Consumer Healthcare. His company is one of those in pharma looking to help improve health literacy and support people to manage their everyday health.
“In times of uncertainty and ‘fake news’, it is our responsibility to provide guidance and clarity to our patients and consumers,” he said.
“If we want to overcome misinformation and improve health literacy, we need to explain science to people in a way they understand, using the right channel, at the right time, so they can make informed decisions and find the products and sources of information they know they can trust.”
However, a GSK-commissioned study on the health-economic benefits of self-care in Europe published last month found that poor health literacy continues to pose a major challenge to self-care.
It revealed that 80% of Europeans accept that it is their responsibility to manage their own health and are willing to do so, but only 2 in 10 feel very confident in managing their own health.
Discussing the study’s findings Professor Lieven Annemans, senior full professor health economics at Ghent University, said: “Better health literacy creates empowered individuals who can take better control of their own health and make the right choices. There is a clear opportunity for governments, health systems, regulators and healthcare professionals to work together to remove this barrier in order to enable people to engage in self-care with confidence.”
An ‘infodemic’ of misinformation and fake news
Alongside pharma efforts to highlight the scale of the health literacy problem and work towards solutions, it’s clear that the problem of misinformation requires action from both governments and the tech giants that have allowed it to spread almost unchecked.
Facebook said in March it had been “taking aggressive steps to stop misinformation and harmful content from spreading” ever since the WHO declared COVID-19 to be a global public health emergency at the beginning of 2020.
In a sign that more concerted action was needed, in April the social network started displaying messages in people’s News Feeds if they had interacted with COVID-related posts subsequently deemed to have violated its policies. In June it started providing more context to COVID-related links and in September it introduced a forwarding limit to its Messenger service.
Those steps were followed in October with a new global policy that banned any adverts that would discourage people from getting vaccinated, whether for COVID, the flu or anything else. “We don’t want these ads on our platform,” the company noted, somewhat belatedly.
Meanwhile, Google started this year with the launch of a $3 million fund to tackle misinformation about COVID-19 vaccines.
Alexios Mantzarlis, news and information credibility lead at Google News Lab, said: “The uncertainty and developing nature of the coronavirus pandemic continues to generate related misinformation. The global rollout of COVID-19 vaccines is exacerbating a perennial problem of misinformation about immunisation.”
The company’s new fund is global in scope and open to news organisations with a proven track record in fact-checking and debunking activities as it aims to broaden the audience of fact checks, particularly to those who may be disproportionately affected by misinformation.
Individuals too have an important role to play, and the WHO has seven tips to help people flatten what it calls the ‘infodemic’ curve.
Pharma’s chance to help
Starting with prescribing information and packaging leaflets, there is a huge opportunity to make health information clearer and easier to understand.
Efforts are afoot to do so and it’s something the Patient Information Forum (PIF) aims to support through the health information accreditation scheme it launched last year.
“One of the things that COVID-19 has really highlighted is how important health literacy is. Materials don’t just need to be evidence based, they also need to be easy to use and understand,” Sophie Randall, PFI’s head of strategy and partnership told pharmaphorum.
“Industry has been under pressure from the EMA to improve the health literacy of prescribing information and packaging leaflets. We know that is complicated because of regulation, but we also think they can rise to the challenge.”
Beyond that pharma companies could be looking to harness their decades of experience in disease awareness for health literacy materials or easy-to-understand vaccine information. This could build on the industry’s already sterling efforts in working against COVID – and there’s certainly a clear need for it.
About the author
Dominic Tyer is a journalist and editor specialising in the pharmaceutical and healthcare industries. He is currently pharmaphorum’s interim managing editor and is also creative and editorial director at the company’s specialist healthcare content consultancy pharmaphorum connect. Connect with Dominic on LinkedIn or Twitter
The post Health literacy needs support, now more than ever appeared first on .
Between them, Royal Philips and Thermo Fisher have been driving a mini M&A spree in the medical technology sector, snapping up three companies in the last few weeks.
Dutch electronics giant Philips’ latest move is to acquire Capsule Technologies, which provides software to link data from medical devices and electronic medical records (EMR) within hospitals, for $635 million in cash.
That agreement comes a few weeks after Philips signed a $2.8 billion deal to buy BioTelemetry – a developer of wearable heart monitors – and also follows an alliance just this week with Merck & Co. to develop a digital approach to personalised fertility treatment.
Capsule’s software is already used by more than 2,800 healthcare organisations around the world for device integration, vital signs monitoring and clinical surveillance services, including in intensive care units. It can be used to analyse data at the patient’s bedside, helping to guide treatment, and generated sales of around $100 million last year.
The platform is designed to work with a wide range of medical devices and equipment – regardless of the manufacturer – and according to Capsule “increases patient visibility, improves collaboration between care teams, simplifies clinical workflows, and gives caregivers more time with patients.”
The company slots neatly into Philips’ current medical device and digital health range, which includes real-time patient monitoring, medical imaging, therapeutic devices, telehealth, health informatics and interoperability software.
“The acquisition of Capsule will further expand our patient care management offering,” said Roy Jakobs, who heads the connected care division at Philips, which will absorb Capsule and its 300 employees based in Massachusetts, US.
Thermo Fisher meanwhile has added to its stable in the last week with the $550 million takeover of Californian firm Mesa Biotech, which has developed a portable diagnostic device for infectious diseases.
That includes SARS-CoV-2 – the virus that causes COVID-19 – as well as influenza A and B, respiratory syncytial virus (RSV) and strep A. Mesa has emergency use authorisation from the FDA for the COVID-19 application and full approvals for the other diseases. Based on a rapid form of polymerase chain reaction (PCR) technology, the unit can deliver a result in 30 minutes.
Thermo is paying $450 million upfront for Mesa with another $100 million on offer if the device meets certain development and sales targets. The San Diego company has 500 employees and made revenues of around $45 million last year.
“The addition of Mesa Biotech’s easy-to-use, rapid PCR-based test is highly complementary to our existing offering and will further help us meet the continuing demand for COVID-related testing while we work to rapidly scale and develop point-of-care tests for other infectious diseases in the future,” said Mark Stevenson, Thermo’s chief operating officer.
The post Philips makes another digital buy, as Thermo adds COVID-19 test maker appeared first on .
Yurts, greenhouses, igloos, tents and all kinds of partly open outdoor structures have popped up at restaurants around the country. Owners have turned to these as a lifeline to help fill some tables by offering the possibility at least of a safer dining experience.
“We’re trying to do everything we can to expand the outdoor dining season for as long as possible,” said Mike Whatley with the National Restaurant Association.
Dire times have forced the industry to find ways to survive. Whatley said more than 100,000 restaurants are either “completely closed or not open for business in any capacity.”
“It’s going to be a hard and tough winter,” Whatley said. “As you see outdoor dining not being feasible from a cold-weather perspective or, unfortunately, from a government regulations perspective, you are going to see more operators going out of business.”
In recent months, many cities and states have imposed a raft of restrictions on indoor dining, given the high risk of spreading the virus in these crowded settings.
Many have capped occupancy for dine-in restaurants. Some halted indoor dining altogether, including Michigan and Illinois. Others have gone even further. Los Angeles and Baltimore have halted indoor and outdoor dining. Only carryout is allowed.
Those who can serve customers outdoors, on patios or sidewalks, are coming up with creative adaptations that can make dining possible in the frigid depths of winter.
Embrace the ‘Yurtiness’
Washington state shut down indoor dining in mid-November and has kept that ban in place as coronavirus cases continue to surge.
On a blustery December evening, servers at the high-end Seattle restaurant Canlis huddled together in the parking lot, clad in flannel and puffy vests, while their boss Mark Canlis gave a pep talk ahead of a busy night.
“The hospitality out here is exactly the same as it is in there,” Canlis said, gesturing to his restaurant, which overlooks Lake Union. “But that looks really different, so try to invite them into the ‘yurtiness’ of what we are doing.”
Canlis has erected an elaborate yurt village in the parking lot next to his family’s storied restaurant.
It includes an outdoor fireplace and wood-paneled walkways winding between small pine trees and the circular tents. The assemblage of yurts, with their open window flaps, is the Canlis family’s best effort to keep fine dining alive during the pandemic and a typically long and wet Seattle winter (referred to locally as the “Big Dark”).
Arriving guests are greeted with a forehead thermometer to take their temperature and a cup of hot cider.
“It gives us an excuse to think differently,” Canlis said of the outdoor dining restrictions.
The yurts are meant to shield diners from the elements and from infectious airborne particles that might otherwise spread from table to table.
Dining inside such structures is not risk free: Guests could still catch the virus from a dining companion as they sit near each other, without masks, for a prolonged period. But Canlis said there is no easy way to determine whether every member of a dining group is from the same household.
“I’m not the governor or the CDC,” he said. “I’m assuming if you are there at the table, you’re taking your health into your own hands.”
New rules for outdoor dining structures in Washington require Canlis to consider issues such as how to ventilate the yurts properly and sanitize the expensive furniture.
“What is the square inch of yurt volume space? What is the size of the door and the windows? How many minutes will we allow the yurt to ‘breathe?’” Canlis said.
The structures get cleaned after each dining party finishes a meal and leaves; during the meal service the waiters enter and leave quickly, wearing N95 masks.
Igloos, Domes, Tents: Just How Safe Are They?
Another, more modern-looking take on outdoor dining involves transparent igloos and other domelike structures that have become popular with restaurant owners all over the country.
Tim Baker, who owns the Italian restaurant San Fermo in Seattle, had to order his igloos from Lithuania and assemble them with the help of his son.
His restaurant’s policy is that only two people are allowed in an igloo at a time, to cut down on the risk of those from different households gathering together.
“You’re completely enclosed in your own space with somebody in your own household. These domes protect you from all the people walking by on the sidewalk, and the server doesn’t go in with you,” he said.
Baker said he consulted with experts in airflow and decided to use an industrial hot air cannon after each party of diners leaves the igloo and before the next set enters — aiming to clear the air inside the structure of any lingering infectious particles.
“You fire this cannon up, and it just pushes the air through really aggressively,” quickly dispersing the particles, Baker said.
His restaurant’s igloos have become a big attraction.
“I’m particularly proud of anything that we can do to get people excited right now, because we need it,” he said. “We’re all getting crushed by this emotionally.”
Not all outdoor dining structures are created equally, said Richard Corsi, an air quality expert and dean of engineering and computer science at Portland State University in Oregon.
“There’s a wide spectrum,” Corsi said. “The safest that we’re talking about is no walls — a roof. And then the worst is fully enclosed — which is essentially an indoor tent — especially if it doesn’t have really good ventilation and good physical distancing.”
In fact, Corsi said, some outdoor dining structures that are enclosed and have lots of tables near each other end up being more dangerous than being indoors, because the ventilation is worse.
Dining that is truly outdoors, with no temporary shelter at all, is much safer because there are “higher air speeds, more dispersion and more mixing than indoors,” Corsi said, which means respiratory droplets harboring the virus don’t accumulate and are less concentrated when people are close to one another.
“If they have heaters, then you’re going to actually have pretty good ventilation,” Corsi said. “The air will rise up when it’s heated, and then cool air will come in.”
He said private “pods” or “domes” can be fairly safe if they are properly ventilated and cleaned between diners. That also assumes that everyone eating inside the structure lives together, so they have already been exposed to one another’s germs.
But Corsi said he is still not going out for a meal in one of the many new outdoor dining creations — “even though I know they’ve got a much lower risk” of spreading covid-19 than most indoor alternatives.
This story comes from NPR’s health reporting partnership with Kaiser Health News.
USE OUR CONTENT
This story can be republished for free (details).
86% of respondents to a recent Veeva survey of pharma and biotech professionals said they are creating a greater volume of content now, compared to six months ago. Yet while many pharma companies are creating more content than ever before, they also face increased pressure to quickly deliver highly personalised – and compliant – content to HCPs.
The proliferation of digital channels – and the COVID-promoted shift to remote working – have focused attention on speed and quality, so further work is needed to make the content creation process more efficient and less prone to error.
At a time when pharma marketing materials are often recreated and reapproved multiple times, and when regional teams can struggle to reuse assets across different regions, a dramatic shift in how to draft, review and distribute assets is needed. Modular content can provide a new foundation for creating relevant commercial content faster and at scale.
To assist executives in life sciences with scaling marketing assets in a virtual world Veeva has published a new eBook, Powering Omnichannel Strategies with Modular Content.
Acknowledging that life science companies are on a continuing journey with their use of modular marketing content, the eBook looks at how speed, personalisation and compliance will define the future of the content ecosystem – from creation all the way through to omnichannel delivery.
The publication provides:
- A clear process for creating pharma modular content
- A roadmap for bringing modular content to life
- The key questions sales and marketing executives should ask of their content
- An outline of the metrics for success that can be applied
- A way to approach change management in modular content
The post Plugging modular content into pharma’s omnichannel strategies appeared first on .
Little Havana is a neighborhood in Miami that, until the pandemic, was known for its active street life along Calle Ocho, including live music venues, ventanitas serving Cuban coffee and a historic park where men gather to play dominoes.
But during the pandemic, a group called Healthy Little Havana is zeroing in on this area with a very specific assignment: persuading residents to get a coronavirus test.
The nonprofit has lots of outreach experience. It helped with the 2020 census, for example, and because of the pandemic did most of that work by phone. But this new challenge, community leaders say, needs a face-to-face approach.
The group’s outreach workers have been heading out almost daily to walk the quiet residential streets, to persuade as many people as possible to get tested for covid-19. On a recent afternoon, a group of three — Elvis Mendes, María Elena González and Alejandro Díaz — knocked on door after door at a two-story apartment building. Many people here have jobs in the service industry, retail or construction; most of them aren’t home when visitors come calling.
Lisette Mejía did answer her door, holding a baby in her arms and flanked by two small children.
“Not everyone has easy access to the internet or the ability to look for appointments,” Mejía replied, after being asked why she hadn’t gotten a test. She added that she hasn’t had any symptoms, either.
The Healthy Little Havana team gave her some cotton masks and told her about pop-up testing planned for that weekend at an elementary school just a short walk away. They explained that people might lack symptoms but still have the virus.
Testing Is Still Too Difficult
The nonprofit organization is one of several receiving funding from the Health Foundation of South Florida. The foundation is spending $1.5 million on these outreach efforts, in part to help make coronavirus testing as accessible and convenient as possible.
A number of social and economic reasons make it difficult for some Miamians to get tested or treated, or isolate themselves if they are sick with covid. One big problem is that many people say they can’t afford to stay home when they’re sick.
“People usually rather go to work than actually treat themselves — because they have to pay rent, they have to pay school expenses, food,” said Mendes.
This part of Miami is home to many Cuban exiles, as well as people from all over Latin America. Some lack health insurance, while others are undocumented immigrants.
So Mendes and his team try to spread the word among residents here about programs like Ready Responders, a group of paramedics that now has foundation funding to give free coronavirus tests at home in areas like this one, regardless of immigration status.
“Our mission is for all these people to get tested — regardless if they have a symptom or not — so we can diminish the level of people getting covid-19,” Mendes said. According to the Centers for Disease Control and Prevention, people who are infected but presymptomatic or asymptomatic account for more than 50% of transmissions.
The Health Foundation of South Florida’s coronavirus-related grants have ranged from $35,000 to $160,000; other recipients include the South Florida chapter of the National Medical Association, Centro Campesino and the YMCA of South Florida.
The foundation is focusing on low-income neighborhoods where some residents might not have access to a car or be able to afford a coronavirus test at a pharmacy. Their focus includes residential areas near agriculture work sites. In Miami-Dade County, the foundation is working with county officials directly to increase testing. In neighboring Broward County, the foundation is collaborating with public housing authorities to bring more testing into people’s homes.
Soothing Fears, Offering Options in Spanish
It’s time-consuming to go door to door, but worthwhile: Residents respond when outreach teams speak their language and make a personal connection.
Little Havana resident Gloria Carvajal told the outreach group that she felt anxious about whether the PCR test is painful.
“What about that stick they put all the way up?” Carvajal asked, laughing nervously.
González jumped in to reassure her it’s not so bad: “I’ve done it many times, because obviously we’re out and about in public and so we have to get the test done.”
Another outreach effort is happening at Faith Community Baptist Church in Miami. The church hosted a day of free testing back in October, with help from the foundation.
“You know us. You know who we are,” said pastor Richard Dunn II. “You know we wouldn’t allow anybody to do anything to hurt you.”
Dunn spoke recently in nearby Liberty City, a historically Black neighborhood, at an outdoor memorial service for Black residents who have died of covid. To convey the magnitude of the community’s losses, hundreds of white plastic tombstones were set up behind the podium. They filled an entire field in the park.
“Thousands upon thousands have died, and so we’re saying to the Lord here today, we’re not going to let their deaths be in vain,” Dunn said.
Dunn is also helping with a newly launched effort to build trust in the covid vaccines among Black residents, by participating in online meetings during which Black church members can hear directly from Black medical experts. The message of the meetings is that the vaccines are safe and vital.
“It’s taken over 300,000 lives in the United States of America,” Dunn said at the end of the meeting. “And I believe to do nothing would be more of a tragedy than to at least try to do something to prevent it and to stop the spreading of the coronavirus.”
Churches will play a big role in the ongoing outreach efforts, and Dunn is committed to doing his part. He knows covid is an extremely contagious and serious disease — this past summer, he caught it himself.
USE OUR CONTENT
This story can be republished for free (details).
Use Our Content
It can be republished for free.
Joe Biden on Wednesday took the oath to become the 46th president of the United States, vowing to bring the nation together in the midst of an ongoing pandemic that has claimed more than 400,000 lives, enormous economic dislocation and civil unrest so serious that the U.S. Capitol steps where he took his oath were surrounded not by cheering crowds, but by tens of thousands of armed police and National Guard troops.
In his inaugural address, given outside despite concerns for his physical security, Biden emphasized unity, the driving theme of his campaign. “My whole soul is in this, bringing America together, uniting our nation,” he said. “And I ask every American to join me in this cause.”
On health care, Biden made it clear that combating the covid-19 pandemic will be his top priority. “We must set aside politics and finally face this pandemic as one nation,” he said. “We will get through this together.”
Last week, Biden unveiled a covid plan that includes using the Defense Production Act to speed the manufacture of syringes and other supplies needed to administer vaccines; creating federal vaccination centers and mobilizing the Federal Emergency Management Agency, the National Guard and others to administer the vaccines, and launching a communications campaign to convince reluctant members of the public that the vaccine is safe. Details on his vaccination plan followed his unveiling the day before of a $1.9 trillion covid emergency relief package.
Biden got a separate boost earlier in the day with the swearing in of two new Democratic senators from Georgia, fresh off their victories in a Jan. 5 runoff election. The additions of Sen. Jon Ossoff and Raphael Warnock, plus a tie-breaking vote from new Vice President Kamala Harris, gives Democrats 51 votes in the Senate and effective control of both chambers of Congress for the first time since 2010.
With such narrow majorities in the House and Senate, it seems unlikely Biden will be able to make good on some of his more sweeping health-related campaign promises, including creating a “public option” to help expand insurance coverage and lowering the Medicare eligibility age from 65 to 60.
But even the barest of control will make it substantially easier for Biden to get his appointees confirmed in the Senate, and the possibility is open to use a fast-track process called budget reconciliation to make health-related budget changes, perhaps including modifications of the Affordable Care Act that might make coverage less expensive for some families.
Beyond covid, health is likely to take a back seat in the early going of the administration as officials deal with more pressing problems like the economy, immigration and climate change.
Biden health aides are expected to begin to unwind many of the changes made by Trump that do not require legislation, such as restoring anti-discrimination protections for transgender people and reversing the Trump administration’s decision to allow some states to implement work requirements for adults covered by Medicaid. But even that could take weeks or months.
USE OUR CONTENT
This story can be republished for free (details).
Overcoming Anxiety in the pandemic times!!
The year has been a tough journey for all of us. It has taught us many lessons that are going to stay with us for the whole of our lives. Thus, DelveInsight has decided to take you all on a ride full of experiences – some bitter and some sweet – yet with the power to impact lives positively and assure everyone that “We’re all in this together!”
So, Let’s hear from our COO.
Last year has been so full of stress and anxiety for most of us in some or the other way. I realized the depth of the situation more when I connected virtually with all of my employees on a one-to-one basis where we could not just hear each other voices after so long, but also could feel each other’s emotions. Few were freshers who joined during the pandemic, few who attended the office in person for a few months, and our dear old folks.
Each one seemed to be waiting for this doomsday scenario to end. For most of them, someone in their immediate family, or they appeared to be anxious. And the prolonged situation, without a doubt, made it worse for many. However, connecting helped all of us in more than one way. We could feel that we are not alone, there are similar people out there going through the same and were willing to lend an ear, and extend a helping hand to those who needed it.
Honestly, this unprecedented situation taught us several things. Now that I turn back and think of it, there is so much to talk on mental health, anxiety and depression. Here, I would take this opportunity to pen down my journey through the situation and share my learnings with you.
Even though I could not just stop writing about it, still I have tried to keep it crisp and relatable so that I could connect with you. While writing, my intent was to share the information, but my purpose was also to connect with you emotionally.
Just like we can feel happiness, sadness, anger, and anguish. Similarly, anxiety is also a feeling. All of us go through it at one point or another, and it is perfectly normal to feel it. For instance, let us talk about stage-fright. Howsoever well prepared we might be, just before going on the stage and facing the audience, we all feel a bit of nervousness, don’t we?
Similarly, let us rewind to our good old school days. Before a day of any exam, we all feared results. Talking about current times, what about heebie-jeebies that we feel while talking to managers regarding appraisals. By now, I am pretty sure directly, you can relate to what exactly I am trying to say.
So, friends, what exactly is anxiety? Anxiety feels different depending on the person experiencing it. Feelings can range from butterflies in your stomach to a racing heart. You might feel out of control like there’s a disconnect between your mind and body. Or you may have nightmares or panic attacks. And sometimes, painful thoughts or memories resurface that may be beyond your control. You may have a general feeling of fear and worry, or you may fear a specific place or event. If I talk about myself, I hesitate to use the lift, flight or be in any closed space. Symptoms of general anxiety may include:
- Increased heart rate
- Rapid breathing
- Trouble concentrating
- Difficulty falling asleep
Because, ultimately, prolonged anxiety can lead a sane person to experience depression. Knowing anxiety the way I do, I know that we need to work on it. Whosoever can deal with it emerges as a winner, others struggle. Those who struggle, all of their wisdom or intellect fail to help them.
Putting it scientifically, we have two kinds of the nervous system, sympathetic and parasympathetic. The sympathetic nervous system prepares the body for intense physical activity and is often referred to as the fight-or-flight response. On the other hand, the parasympathetic nervous system has almost the exact opposite effect and relaxes the body and inhibits or slows down many high energy functions.
No doubt both are very much required for our existence, but just imagine if all the time, we start gearing up our nervous system? What would happen to our body? Imagine a car is given the amount of petrol needed to reach Chennai from Delhi and it moves just fine if handled with the right gear, functional brakes and accurate acceleration, as required. If we start rushing it by accelerating unnecessarily on the top-most gear – the one which is meant to pull through the steeps, what would happen then? We would finish our fuel halfway through our journey.
Same happens with our lives. People in early days were calm, peaceful and much contented with what they had; therefore, they did not worry much about anything. They used to remain on their parasympathetic infrastructure, contrary to what happens today when most of us run on sympathetic most of the time, exhausting our energy much too soon. So, friends, activate your sympathetic nervous system for a war-like situation to fight emergency, because do remember your body in that mode cut supplies to all other vital organ and sends its resources more to heart and muscles to fight that situation. Also, do not forget to switch off the machine when the need is over.
Anxiety is the result of worry. Often, we cannot identify the actual reason behind it; however, identifying the cause is as important as addressing the issue itself. Suppose you are not well or tired, you would feel the pain somewhere in the body, you would take proper medicine/rest for that. Similarly, have you ever thought, that if our mind or brain is not feeling that well, how would it notify you?
Yes, it sends apparent signals in sadness, mood swings, and anxiety; we need to pick them fast before it gets more difficult for us. Stop everything and first work on maintaining your mind, because it is the boss of your body and believe me, our mind is just like a small child who also needs a break from the daily stressful, mundane routine.
Do what you love, sing out loud, listen to some lovely music, chill with friends, meditate, do whatever you love to. It is imperative. Our positivity can help us overcome anxiety very well. This is why we are told to develop hobbies. Hobbies are something where we tend to forget about, but we need to pick them up along with the rest of the things and spend time on what we love, and that brings us back to our real self, which is meant to be cheerful, happy and relaxed.
So, guys, it is OK to be NOT OK. But unfortunately, many of us do not understand this language. Some feel confused, or to be precise, shy about it. Few are not comfortable talking about it to anyone. If we immediately seek medical attention for physical ailments, then why not for emotional/mental stress? Instead, this is more important. It is a massive taboo in a society that needs serious attention. It is high time we start to talk about it.
I will dig deeper into my case. My claustrophobia was well handled by a psychologist. I was able to travel several countries, and each was a separate win for me, travelling for so long in flights, encouraged by my partner who supported me at each level and celebrated all of my small and big wins.
What I am trying to say is, situations change if we learn to do something about it. If we do not, then our sufferings will continue to pile up. We need to find ways to overcome it.
Now you ask, how? Right? Build a strong network of friends and family, love them unconditionally, strengthen the bond, and the happiness you get in return would not be more comfortable to explain.
Okay! Stretch your muscles now for a small activity. List down the names of at least 3 people whom you could connect and open your heart without thinking twice at any hour of the day, could share your lows, your weaknesses, in short, you can be your true self.
Keep it in your front-most drawer, and during an emotional emergency, take a look, you are the luckiest if you have even one. Just pour your heart out. If you don’t have any name, for now, become one.
There is sometimes a loop of thoughts which becomes difficult to break.
Few rules to be followed which, I have learnt with experience:
- Learn to pick the signals your mind sends.
- Check whether you are running on sympathetic or parasympathetic. For immediate relief, control your breaths because that is the one which gets disturbed first. It gets faster when you are anxious. Close your eyes, sit at a peaceful place, try to slow down its pace for 5 minutes and experience the result.
- Identify the activity which soothes you, relaxes you. Switch to that when you need. It can be anything… stitching, painting, singing, yoga, dancing… the list is endless.
- It’s never too late to develop a hobby, which is the best escape route from mundane life.
- Identify the people with whom you are close, invest in building rich relationships. When I say rich, friends are the richness we all should strive for with all our might. If you have even one who understands you truly, who can listen to you tirelessly, with whom you can be yourself, you have won the world. Talk your heart out, do not give it a thought, express your genuine emotions, and not hesitate.
- It’s perfectly ok not to be okay, seek medical help if needed, take medicine if advised, shake off the taboo, life is far more precious than these petty things, enjoy it, live it to the fullest.
- Follow a healthy routine, it elevates the mood. Inculcating the habit to exercise releases endorphin – the happiness hormone- which helps our mind reduce stress.
- Take a break without applying logic, have fun, this is only one life that we have got. Be yourself.
- Meditation is one of the most helpful tools, just imbibe it within. Your subconscious mind can do wonders, just keep repeating and reminding it that you are a beautiful soul, powerful soul and perfectly fine. What we say, we ultimately become. Sit quietly by yourself for at least 10 minutes. I am not a meditation expert, just have begun but felt the wonders.
- Last but not least, become a true friend of someone as you wish for yourself, you never know you might be his/her only trustworthy friend. Believe me, happiness doubles when spread.
That’s all my friend, I won’t say thank you, instead I would express my gratitude for giving your precious time to read, which at the first place empowered me to express myself.
Our COO, Preeti Agrawal, is a market research consultant with around 16 years of experience. She is a science graduate and has done her masters in computer application. Prior to joining DelveInsight, she worked with Toluna (GreenField), Kadence, and Internationallinx. She was actively engaged in client interaction, handling client queries, providing them with feasible solutions & building healthy relationships thereby achieving high customer satisfaction. She has mastered the art of maintaining relationships with customers to achieve repeat/referral business.
Esa promesa se cumplió, pero muchas otras no, como la de Bill Clinton de lograr una atención médica universal o la George H.W. Bush de no generar nuevos impuestos.
Ahora, durante una pandemia que ocurre una vez en un siglo, Joe Biden ha prometido proporcionar 100 millones de dosis de vacunas contra covid-19 en sus primeros 100 días de mandato.
“Este equipo ayudará a que 100 millones de dosis lleguen a los brazos de los estadounidenses en los primeros 100 días”, dijo Biden en la conferencia de prensa del 8 de diciembre en la que presentó a su equipo de salud.
Luego de esa afirmación, la campaña de Biden aclaró que se había referido a que 50 millones de personas recibirían sus dos dosis. Más tarde aclararon que distribuirían las dosis a medida que estuvieran disponibles, en vez de retener suministros para las segundas dosis.
De cualquier manera, la meta de Biden parece difícil de alcanzar.
“Creo que es un objetivo posible. Pero también un gran desafío”, dijo Claire Hannan, directora ejecutiva de la Association of Immunization Managers.
“Mientras que el ritmo de 1 millón de dosis al día es en alguna medida un aumento con respecto a lo que estamos haciendo ahora, será necesaria una tasa mucho más alta de vacunación para frenar la pandemia”, dijo Larry Levitt, vicepresidente ejecutivo para políticas de salud de la Kaiser Family Foundation (KFF).
“La administración Biden planea racionalizar la distribución de vacunas, pero aumentar el suministro rápidamente podría ser una tarea difícil”, agregó.
Bajo la administración Trump, el despliegue de vacunas ha sido mucho más lento que el plan de Biden. El lanzamiento comenzó el 14 de diciembre. Desde entonces, se han administrado 12 millones de dosis y se han distribuido 31 millones, según el monitoreo de vacunación de los Centros para el Control y Prevención de Enfermedades (CDC).
Esta lentitud se ha atribuido a la falta de comunicación entre el gobierno federal y los departamentos de salud estatales y locales. También a la falta de fondos para una vacunación a gran escala, y a la confusa orientación del gobierno federal sobre la distribución.
La administración Biden podría tener los mismos problemas, según expertos. Los estados aun no están seguros de cuántas vacunas recibirán y si habrá un suministro suficiente, dijo el doctor Marcus Plescia, director médico de la Association of State and Territorial Health Officials, que representa a las agencias de salud pública estatales.
“Se nos ha proporcionado poca información sobre la cantidad de vacunas que recibirán los estados en el futuro cercano y puede que no haya un millón de dosis disponibles cada día en los primeros 100 días de la administración”, dijo Plescia.
Otro problema ha sido la falta de dinero: los estados han tenido que iniciar campañas de vacunación con presupuestos esqueléticos a causa de la pandemia. “Los estados deben pagar por crear los sistemas, identificar al personal y capacitarlos, el rastreo de contactos, las campañas de información, todo lo que necesitan para terminar vacunando a una persona”, explicó Jennifer Kates, directora de política global y VIH de KFF. “Tienen que crear un programa de vacunación masiva si precedentes sobre una base inestable”, observó.
El último estímulo para covid, promulgado en diciembre, asignó $9 mil millones en fondos a los CDC para esfuerzos de vacunación. Se supone que la mitad, unos $45 mil millones se destinarán a estados, territorios y reservas indígenas.
Pero cuando la vacunación se amplíe a más grupos, no está claro si las campañas se puedan sostener con ese nivel de financiamiento.
La semana del 11 de enero, Biden lanzó un plan de $1.9 mil millones para abordar los problemas de la economía y covid. Incluye dinero para crear programas nacionales de vacunación y pruebas, pero también para asistencia financiera a individuos, ayuda a gobiernos locales, extensión del seguro de desempleo y dinero para que las escuelas reabran de manera segura.
Aunque el Congreso tardó casi ocho meses en aprobar el último proyecto de ley de ayuda tras las objeciones republicanas, Biden parece optimista de que logrará que algunos republicanos se unan a su plan. Pero aún no está claro que funcione. También está la cuestión de si el juicio político del presidente saliente Donald Trump se interpondrá en el camino de las prioridades legislativas de Biden.
Además, los estados se han quejado de la falta de orientación e instrucciones confusas sobre a qué grupos se les debe dar prioridad para la vacunación, un tema que la administración Biden deberá abordar.
El 3 de diciembre, los CDC recomendaron que el personal de atención médica, los residentes de centros de atención a largo plazo, las personas de 75 años o más y los trabajadores esenciales de primera línea se vacunaran primero.
Pero el 12 de enero, los CDC cambiaron de rumbo y recomendaron que todas las personas mayores de 65 años debían vacunarse. Biden dijo que seguiría esta recomendación.
El secretario saliente de Salud y Servicios Humanos, Alex Azar, también dijo el 12 de enero que los estados que muevan su suministro de vacunas más rápido tendrán prioridad para recibir más envíos.
Aún no se sabe si los CDC de la administración de Biden se apegarán a esta guía. Los críticos han dicho que podría hacer que la distribución de vacunas sea menos equitativa. En general, asumir el control con una visión sólida y una comunicación clara será clave para aumentar la distribución de vacunas, dijo Hannan.
“Todos deben comprender cuál es el objetivo y cómo va a funcionar”, agregó.
Un desafío para Biden será frenar las expectativas de que la vacuna es todo lo que se necesita para poner fin a la pandemia. En todo el país, hay más casos de covid que nunca y en muchos lugares los funcionarios no pueden controlar la propagación.
Los expertos en salud pública dijeron que Biden debe intensificar los esfuerzos para aumentar las pruebas en todo el país, como ha sugerido que hará al prometer establecer una junta nacional de pruebas de pandemias.
Con el fuerte enfoque en la distribución de vacunas, es importante que esta parte de la ecuación no se pierda.
En este momento, “está en todo el mapa”, dijo Kates de KFF, y agregó que el gobierno federal necesitará tener un claro sentido de las áreas del país en donde se están haciendo las pruebas y en las que no, para “arreglar” esa capacidad de salud pública.
USE OUR CONTENT
This story can be republished for free (details).
Laboratory studies have confirmed that antibodies stimulated by Pfizer and BioNTech’s COVID-19 vaccine can neutralise the new, more transmissible variant of SARS-CoV-2 identified in the UK.
The results of the study – published online prior to peer review – are among the first data to indicate that any of the approved coronavirus vaccines can effectively target the mutated spike protein in the UK strain, known as B.1.1.7 lineage or VOC 202012/01.
According to the World Health Organization (WHO) the variant has now been seen in at least 60 countries worldwide. It is estimated to be somewhere between 50% and 70% more infectious than the original strain of SARS-CoV-2, but as yet there’s no evidence that it causes more severe COVID-19.
Pfizer and BioNTech previously showed that their BNT162b2 vaccine – now known as Comirnaty – was able to generate antibodies against one of the key mutations (N501Y) in the UK strain, which also appears in the South African variant, also raising concern worldwide.
VOC 202012/01 has an unusually high number of genetic changes however, with 10 mutations affecting the spike protein.
To test its activity further, Pfizer and BioNTech scientists created a non-replicating pseudovirus – featuring the full range of mutations in the UK strain’s spike protein – to test in the lab and found that BNT162b2 generated neutralising antibodies against it in the same range as seen with the unmutated virus.
“While the pseudovirus system used is a surrogate for authentic SARS-CoV-2, previous studies have shown excellent concordance between pseudotype neutralisation and SARS-CoV-2 neutralisation assays,” they said.
The paper suggests it is “unlikely” that the UK variant differs sufficiently from the original virus that recognition by neutralising antibodies generated by BNT162b2 will be affected, according to the authors.
“Unlike for influenza vaccines, the reduction in neutralisation that might indicate the need for a strain change has not been established for COVID-19 vaccines,” it goes on.
That is good news, but a less encouraging study has just been reported by South African researchers that the variant that was first discovered in their country – known as 501Y.V2 – does exhibit mutations that could make it evade immunity from a prior coronavirus infection.
The team led by Professor Penny Moore, from the National Institute for Communicable Diseases found that 48% of blood samples from 44 people who had been infected in the past did not show neutralising activity at all, while in the other half it was reduced.
That suggests that patients could get SARS-CoV-2 twice, but also that the current crop of vaccines may not be as effective. Once again, that study hasn’t yet been subjected to peer review.
The post Pfizer/BioNTech say COVID-19 vaccine works against UK variant appeared first on .
UK biotech ConserV Bioscience has joined with California’s Lawrence Livermore National Laboratory to develop broad-spectrum coronavirus vaccines as concerns mount over potentially more infectious strains emerging in the UK, South Africa and Brazil.
This collaboration brings together ConserV’s expertise in identifying antigens and Lawrence Livermore National Laboratory’s (LLNL) nanolipoprotein particle technology (“NLP”) delivery system.
The vaccine has been designed to provide broad-spectrum protection against coronavirus pathogens of human and animal origin, including but not limited to MERS, SARS and SARS-CoV-2.
A genomic analysis of the SARS-CoV-2 coronavirus, which causes COVID-19, shows that the virus accumulates around two mutations a month.
The new variant identified in the UK in December shows significant mutations in the Spike protein and receptor binding domain that increase its infectivity.
The variant that originated in South Africa carries a mutation in the Spike protein that has been shown to reduce antibody recognition and could therefore affect efficacy of new vaccines.
Meanwhile the variant that originated in Brazil is thought to be more infectious and a virus closely resembling it was found in a patient reinfected with SARS-CoV-2.
The partnership aims to develop a vaccine consisting of regions of genetical material from each coronavirus that causes an immune reaction.
These will be encoded in messenger RNA (mRNA) formulated with the laboratory’s NLP technology before injection.
This will allow freeze drying of both components separately, improving storage and transport conditions compared to other mRNA vaccines – Pfizer and Moderna’s shots require ultra-cool temperatures to maintain their integrity.
Vaccine formulation was funded by the Department of Health and Social Care through an SBRI programme managed by Innovate UK.
The collaboration aims to demonstrate the immunogenicity and protective responses in pre-clinical studies with clinical studies following quickly if results are supportive.
Kimbell Duncan, CEO of ConserV Bioscience, said: “Our mission is to develop safe and effective vaccines which offer broad protection against infections from viruses that mutate frequently.
“We are pleased to be working with Lawrence Livermore National Laboratory to develop our broad-spectrum coronavirus vaccine candidate. We have identified regions within the proteins of the virus that are not susceptible to change and, if effective, the vaccine promises to protect against a broad spectrum of current circulating coronavirus strains and future emergent ones.”
NLPs are water-soluble molecules that are 6 to 30 billionths of a meter in size, resembling high-density lipoprotein (HDL) particles, which are associated with playing a role in regulating the human body’s ‘good’ cholesterol. LLNL scientists are working to use this nanotechnology, also known as nanodiscs, as a delivery platform for tularemia and chlamydia vaccines that are under development.
Feature image courtesy of Rocky Mountain Laboratories/NIH
The post ConserV Bioscience works on mutation-proof coronavirus shots with US lab appeared first on .
One in 11 adults aged over 65 have reported a lack of willingness to receive a COVID-19 vaccine, according to a US-based survey.
The findings are concerning given that adults in this group are at highest risk for complications from the disease.
Recruitment to the study began in February last year and it was initially set up to test whether wearable and custom-built mobile apps could enable earlier detection and better treatment of atrial fibrillation in patients aged 65 and older.
Willingness to vaccinate against COVID-19 was assessed through an optional survey through the Johnson & Johnson app between 6th and 20th November last year,
The assessment included questions on beliefs about vaccines in general, beliefs about COVID-19 and the COVID-19 vaccine, and opinions on vaccine dosing and potential side effects.
Shortly after the survey was offered, Pfizer announced first interim analysis results showing the vaccine it developed with BioNTech had an efficacy of around 90% and authors compared answers before and after this event to gauge its impact on opinions.
Of the 7,402 people who responded, 63.6% of participants reported they were very willing to receive a COVID-19 vaccine, 27.8% were somewhat willing, 6.0% were not very willing, and 2.6% were not at all willing.
Overall, authors said that 91.3% were “willing” to be immunised and 8.7% were “unwilling”.
Analysing different demographic groups, the study found participants identifying as Black or African American were least likely to want to take COVID-19 vaccines.
A total of 26.8% of Black or African American participants noted they were not very willing or not at all willing to vaccinate, compared with 8.0% of white participants.
Study author Janeta Nikolovski, director of the World Without Disease Accelerator at Johnson & Johnson’s Janssen pharma unit, told pharmaphorum in an emailed interview that she not surprised about vaccine hesitancy in older age groups.
“Several prior published studies have shown those trends as well,” said Nikolovski, who said further work is being done to understand why older people are more likely to be sceptical about vaccines.
She added: “Among those who said they were unwilling to get vaccinated, the majority stated that they would discuss their decision with their healthcare provider, providing an important opportunity for education.”
Further work is also needed to identify why different demographic groups have differing attitudes to the vaccine.
She added: “We agree that further study is needed and a one-size-fits all approach in communication will not be ideal to address specific concerns.”
Nikolovski is hopeful that as vaccine campaigns are rolled out, attitudes to vaccines could change for the better.
“Given that we found vaccine safety and efficacy to be a strong predictor of willingness to vaccinate, I think as people get vaccinated and share their experience with others, trust will grow.
“We saw an increased vaccine willingness after the trial results were released, suggesting that public willingness to vaccinate may continue to rise as additional positive data are released.”
Conversely, negative news stories about vaccines, including reports about adverse events, may have a negative impact.
“In general however, I believe transparency with research results is important, whatever the results, as it is important to realistically manage expectations, “ she concluded.
Janssen is working on a single shot COVID-19 vaccine, which has shown promise in early trials with phase 3 data possibly due by the end of the month.
The post One in 11 over-65s unwilling to take COVID-19 shot appeared first on .
California’s telemetry nurses, who specialize in the electronic monitoring of critically ill patients, normally take care of four patients at once. But ever since the state relaxed California’s mandatory nurse-to-patient ratios in mid-December, Nerissa Black has had to keep track of six.
And these six patients are really sick: Many of them are being treated simultaneously for a stroke and covid-19, or a heart attack and covid. With more patients than usual needing more complex care, Black said she’s worried she’ll miss something or make a mistake.
“We are given 50% more patients and we’re expected to do 50% more things with the same amount of time,” said Black, who has worked at the Henry Mayo Newhall Hospital in Valencia, California, for seven years. “I go home and I feel like I could have done more. I don’t feel like I’m giving the care to my patients like a human being deserves.”
As covid patients continue to flood California emergency rooms, hospitals are increasingly desperate to find enough staffers to care for them all. The state is asking nurses to tend to more patients simultaneously than they typically would, watering down what many nurses and their unions consider their most sacrosanct job protection: a law existing only in California that puts legal restrictions on the nurse-to-patient ratio.
“We need to temporarily — very short-term, temporarily — look a little bit differently in terms of our staffing needs,” said Gov. Gavin Newsom, after he quietly allowed hospitals to adjust their nurse-to-patient ratios on Dec. 11. Usually, California law requires a hospital to first get approval from the state before tinkering with those ratios; Newsom’s move gave hospitals presumptive approval to work outside the ratio rules immediately.
Since then, 188 hospitals, mainly in Southern California, have been operating under the new pandemic ratios: They can require ICU nurses to care for three patients instead of two. Emergency room and telemetry nurses may now be asked to care for six patients instead of four. Medical-surgical nurses are looking after seven patients instead of five.
Nurses have taken to the streets in protest, holding physically distanced demonstrations across the state, shouting and carrying posters that read: “Ratios Save Lives.” The union, the California Nurses Association, says the staffing shortage is a result of bad hospital management, of taking a reactive approach to staffing rather than proactive — laying nurses off over the summer, then not hiring or training enough for winter.
“What we’re seeing in these hospitals is their just-in-time response to a pandemic that they never prepared for — just-in-time staffing, just-in-time resources, not staffing up, calling nurses in on a shift at the very last minute — to boost profits,” said Stephanie Roberson, government relations director for the California Nurses Association. “And we’re seeing how nurses are being stretched even thinner.”
But hospitals say this is an unprecedented crisis that has spiraled beyond their control. In the current surge, four times as many Californians are testing positive for the coronavirus compared with the summer’s peak. As many as 7,000 new patients could soon be coming to California hospitals every day, according to Carmela Coyle, who heads the California Hospital Association.
“This is catastrophic and we cannot dodge this math,” she said. “We are simply out of nurses, out of doctors, out of respiratory therapists.”
The state has asked the federal government for staff, including 200 medical personnel from the Department of Defense, and it’s tried to reactivate the California Health Corps, an initiative to recruit retired health workers to come back to work. But that has yielded few people with the qualifications needed to care for hospitalized covid patients.
Hiring contract nurses from temporary staffing agencies or other states is all but impossible right now, Coyle said.
“Because California surged early during the summer and other parts of the United States then surged afterward,” she said, “those travel nurses are taken.“
The next step for hospitals is to try “team nursing,” Coyle said — pulling nurses from other departments, like the operating room, for example, and partnering them with experienced critical care nurses to help care for covid patients.
Joanne Spetz, an economics professor who studies health care workforce issues at the University of California-San Francisco, said hospitals should have started training nurses for team care over the summer, in anticipation of a winter surge, but they didn’t, either because of costs — hospitals lost a lot of revenue from canceled elective surgeries that could have paid for that training — or because of excessive optimism.
“California was doing so well,” she said. “It was easy for all of us to believe that we kind of got it under control, and I think there was a lot of belief that we would be able to maintain that.”
The California Nurses Association has good reason to be defensive regarding the integrity of the patient-ratio law, Spetz said. It took 10 years of lobbying and activism before the bill passed the state legislature in 1999, then several more years to overcome multiple court challenges, including one from then-Gov. Arnold Schwarzenegger.
“I’m always kicking their butt, that’s why they don’t like me,” Schwarzenegger famously said of nurses, drawing broad ire from the nurses union and its allies.
Nurses prevailed in the court of public opinion and in law; rules that put a legal cap on the number of patients per nurse finally took effect in 2004. But the long battle made nurses fiercely protective of their win. They’ve even accused hospitals of using the pandemic to try to roll back ratios for good.
“This is the exercise of disaster capitalism at its finest, where [hospital administrators] are completely maximizing their opportunity to take advantage of this crisis,” Roberson said.
Hospitals deny they want to change the ratio law permanently, and Spetz said it’s unlikely they’d succeed if they tried. The public can see that nurses are overworked and burned out by the pandemic, she said, so there would be little support for cutting back their job protections once it’s over.
“To go in and say, ‘Oh, you clearly did so well without ratios when we let you waive them, so let’s just eliminate them entirely,’ I think, would be just adding insult to moral injury,” Spetz said.
USE OUR CONTENT
This story can be republished for free (details).
His scratchy throat had turned to a dry cough, headache, joint pain and fever — all warning signs to Herritz, who underwent liver transplant surgery in 2012, followed by a rejection scare in 2018. He knew his compromised immune system left him especially vulnerable to a potentially deadly case of covid.
“The thing with transplant patients is we can crash in a heartbeat,” said Herritz, 39. “The outcome for transplant patients [with covid] is not good.”
On Twitter, Herritz had read about monoclonal antibody therapy, the treatment famously given to President Donald Trump and other high-profile politicians and authorized by the Food and Drug Administration for emergency use in high-risk covid patients. But as his symptoms worsened, Herritz found himself very much on his own as he scrambled for access.
His primary care doctor wasn’t sure he qualified for treatment. His transplant team in Wisconsin, where he’d had the liver surgery, wasn’t calling back. No one was sure exactly where he should go to get it. From bed in Pascagoula, Mississippi, he spent two days punching in phone numbers, reaching out to health officials in four states, before he finally landed an appointment to receive a treatment aimed at keeping patients like him out of the hospital — and, perhaps, the morgue.
“I am not rich, I am not special, I am not a political figure,” Herritz, a former community service officer, wrote on Twitter. “I just called until someone would listen.”
Months after Trump emphatically credited an experimental antibody therapy for his quick recovery from covid and even as drugmakers ramp up supplies, only a trickle of the product has found its way into regular people. While hundreds of thousands of vials sit unused, sick patients who, research indicates, could benefit from early treatment — available for free — have largely been fending for themselves.
Federal officials have allocated more than 785,000 doses of two antibody treatments authorized for emergency use during the pandemic, and more than 550,000 doses have been delivered to sites across the nation. The federal government has contracted for nearly 2.5 million doses of the products from drugmakers Eli Lilly and Co. and Regeneron Pharmaceuticals at a cost of more than $4.4 billion.
So far, however, only about 30% of the available doses have been administered to patients, federal Department of Health and Human Services officials said.
Scores of high-risk covid patients who are eligible remain unaware or have not been offered the option. Research has shown the therapy is most effective if given early in the illness, within 10 days of a positive covid test. But many would-be recipients have missed this crucial window because of a patchwork system in the U.S. that can delay testing and diagnosis.
“The bottleneck here in the funnel is administration, not availability of the product,” said Dr. Janet Woodcock, a veteran FDA official in charge of therapeutics for the federal Operation Warp Speed effort.
Among the daunting hurdles: Until this week, there has been no nationwide system to tell people where they could obtain the drugs, which are delivered through IV infusions that require hours to administer and monitor. Finding space to keep covid-infected patients separate from others has been difficult in some health centers slammed by the pandemic.
“The health care system is crashing,” Woodcock told reporters. “What we’ve heard around the country is the No. 1 barrier is staffing.”
At the same time, many hospitals have refused to offer the therapy because doctors were unimpressed with the research federal officials used to justify its use.
Monoclonal antibodies are lab-produced molecules that act as substitutes for the body’s own antibodies that fight infection. The covid treatments are designed to block the SARS-CoV-2 virus that causes infection from attaching to and entering human cells. Such treatments are usually prohibitively expensive, but for the time being the federal government is footing the bulk of the bill, though patients likely will be charged administrative fees.
Nationwide, nearly 4,000 sites offer the infusion therapies. But for patients and families of people most at risk — those 65 and older or with underlying health conditions — finding the sites and gaining access has been almost impossible, said Brian Nyquist, chief executive officer of the National Infusion Center Association, which is tracking supplies of the antibody products. Like Herritz, many seeking information about monoclonals find themselves on a lone crusade.
“If they’re not hammering the phones and advocating for access for their loved ones, others often won’t,” he said. “Tenacity is critical.”
Regeneron officials said they’re fielding calls about covid treatments daily to the company’s medical information line. More than 3,500 people have flooded Eli Lilly’s covid hotline with questions about access.
As of this week, all states are required to list on a federal locator map sites that have received the monoclonal antibody products, HHS officials said. The updated map shows wide distribution, but a listing doesn’t guarantee availability or access; patients still need to check. It’s best to confer with a primary care provider before reaching out to the centers. For best results, treatment should occur as soon as possible after a positive covid test.
Some health systems have refused to offer the monoclonal antibody therapies because of doubts about the data used to authorize them. Early studies suggested that Lilly’s therapy, bamlanivimab, reduced the need for hospitalization or emergency treatment in outpatient covid cases by about 70%, while Regeneron’s antibody cocktail of casirivimab plus imdevimab reduced the need by about 50%.
But those studies were small, just a few hundred subjects, and the results were limited. “A lot of doctors, actually, they’re not impressed with the data,” said Dr. Daniel Griffin, an infectious disease expert at Columbia University who co-hosts the podcast “This Week in Virology.” “There really is still that question of, ‘Does this stuff really work?’”
As more patients are treated, however, there’s growing evidence that the therapies can keep high-risk patients out of the hospital, not only easing their recovery but also decreasing the burden on health systems struggling with record numbers of patients.
Dr. Raymund Razonable, an infectious disease expert at the Mayo Clinic in Minnesota, said he has treated more than 2,500 covid patients with monoclonal antibody therapy with promising results. “It’s looking good,” he said, declining to provide details because they’re embargoed for publication. “We are seeing reductions in hospitalizations; we’re seeing reductions in ICU care; we’re also seeing reductions in mortality.”
Banking on observations from Mayo experts and others, federal officials have been pushing for wider use of antibody therapies. HHS officials have partnered with hospitals in three hard-hit states — California, Arizona and Nevada — to set up infusion centers that are treating dozens of covid patients each day.
One of those sites went up in late December at El Centro Regional Medical Center in California’s Imperial County, an impoverished farming region on the state’s southern border that has recorded among the highest covid infection rates in the state. For months, the medical center strained to absorb the overwhelming influx of patients, but chief executive Dr. Adolphe Edward said a new walk-up infusion site has already put a dent in the covid load.
More than 130 people have been treated, all patients who were able to get the two-hour infusions and then recuperate at home. “If those folks would not have had the treatment, they would have come through the emergency department and we would have had to admit the lion’s share of them,” he said.
It’s important to make sure people in high-risk groups know to seek out the therapy and to get it early, Edward said. He and his staff have been working with area doctors’ offices and nonprofit groups and relying on word-of-mouth.
“On multiple levels, we’re saying, ‘If you’ve tested positive for the virus, come and let us see if you are eligible,’” Edward said.
Greater awareness is a goal of the HHS effort, said Dr. John Redd, chief medical officer for the assistant secretary for preparedness and response. “These antibodies are meant for everyone,” he said. “Everyone across the country should have equal access to these products.”
For now, patients like Herritz, the Mississippi liver transplant recipient, say reality is falling well short of that goal. If he hadn’t continued to call in search of a referral, he wouldn’t have been treated. And without the therapy, Herritz believes, he was just days away from hospitalization.
“I think it’s horrible that if I didn’t have Twitter, I wouldn’t know anything about this,” he said. “I think about all the people who have died not knowing this was an option for high-risk individuals.”
USE OUR CONTENT
This story can be republished for free (details).
It’s in the nature of presidential candidates and new presidents to promise big things. Just months after his 1961 inauguration, President John F. Kennedy vowed to send a man to the moon by the end of the decade. That pledge was kept, but many others haven’t been, such as candidate Bill Clinton’s promise to provide universal health care and presidential hopeful George H.W. Bush’s guarantee of no new taxes.
Now, during a once-in-a-century pandemic, incoming President Joe Biden has promised to provide 100 million covid-19 vaccinations in his first 100 days in office.
“This team will help get … at least 100 million covid vaccine shots into the arms of the American people in the first 100 days,” Biden said during a Dec. 8 news conference introducing key members of his health team.
When first asked about his pledge, the Biden team said the president-elect meant 50 million people would get their two-dose regimen. The incoming administration has since updated this plan, saying it will release vaccine doses as soon as they’re available instead of holding back some of that supply for second doses.
Either way, Biden may run into difficulty meeting that 100 million mark.
“I think it’s an attainable goal. I think it’s going to be extremely challenging,” said Claire Hannan, executive director of the Association of Immunization Managers.
While a pace of 1 million doses a day is “somewhat of an increase over what we’re already doing,” a much higher rate of vaccinations will be necessary to stem the pandemic, said Larry Levitt, executive vice president for health policy at KFF. (KHN is an editorially independent program of KFF.) “The Biden administration has plans to rationalize vaccine distribution, but increasing the supply quickly” could be a difficult task.
Under the Trump administration, vaccine deployment has been much slower than Biden’s plan. The rollout began more than a month ago, on Dec. 14. Since then, 12 million shots have been given and 31 million doses have been shipped out, according to the Centers for Disease Control and Prevention’s vaccine tracker.
This sluggishness has been attributed to a lack of communication between the federal government and state and local health departments, not enough funding for large-scale vaccination efforts, and confusing federal guidance on distribution of the vaccines.
The same problems could plague the Biden administration, said experts.
States still aren’t sure how much vaccine they’ll get and whether there will be a sufficient supply, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, which represents state public health agencies.
“We have been given little information about the amount of vaccine the states will receive in the near future and are of the impression that there may not be 1 million doses available per day in the first 100 days of the Biden administration,” said Plescia. “Or at least not in the early stages of the 100 days.”
Another challenge has been a lack of funding. Public health departments have had to start vaccination campaigns while also operating testing centers and conducting contact tracing efforts with budgets that have been critically underfunded for years.
“States have to pay for creating the systems, identifying the personnel, training, staffing, tracking people, information campaigns — all the things that go into getting a shot in someone’s arm,” said Jennifer Kates, director of global health & HIV policy at KFF. “They’re having to create an unprecedented mass vaccination program on a shaky foundation.”
The latest covid stimulus bill, signed into law in December, allocates almost $9 billion in funding to the CDC for vaccination efforts. About $4.5 billion is supposed to go to states, territories and tribal organizations, and $3 billion of that is slated to arrive soon.
But it’s not clear that level of funding can sustain mass vaccination campaigns as more groups become eligible for the vaccine.
Biden released a $1.9 trillion plan last week to address covid and the struggling economy. It includes $160 billion to create national vaccination and testing programs, but also earmarks funds for $1,400 stimulus payments to individuals, state and local government aid, extension of unemployment insurance, and financial assistance for schools to reopen safely.
Though it took Congress almost eight months to pass the last covid relief bill after Republican objections to the cost, Biden seems optimistic he’ll get some Republicans on board for his plan. But it’s not yet clear that will work.
There’s also the question of whether outgoing President Donald Trump’s impeachment trial will get in the way of Biden’s legislative priorities.
In addition, states have complained about a lack of guidance and confusing instructions on which groups should be given priority status for vaccination, an issue the Biden administration will need to address.
On Dec. 3, the CDC recommended health care personnel, residents of long-term care facilities, those 75 and older, and front-line essential workers should be immunized first. But on Jan. 12, the CDC shifted course and recommended that everyone over age 65 should be immunized. In a speech Biden gave last week detailing his vaccination plan, he said he would stick to the CDC’s recommendation to prioritize those over 65.
Outgoing Health and Human Services Secretary Alex Azar also said Jan. 12 that states that moved their vaccine supply fastest would be prioritized in getting more shipments. It’s not known yet whether the Biden administration’s CDC will stick to this guidance. Critics have said it could make vaccine distribution less equitable.
In general, taking over with a strong vision and clear communication will be key to ramping up vaccine distribution, said Hannan.
“Everyone needs to understand what the goal is and how it’s going to work,” she said.
A challenge for Biden will be tamping expectations that the vaccine is all that is needed to end the pandemic. Across the country, covid cases are higher than ever, and in many locations officials cannot control the spread.
Public health experts said Biden must amp up efforts to increase testing across the country, as he has suggested he will do by promising to establish a national pandemic testing board.
With so much focus on vaccine distribution, it’s important that this part of the equation not be lost. Right now, “it’s completely all over the map,” said KFF’s Kates, adding that the federal government will need a “good sense” of who is and is not being tested in different areas in order to “fix” public health capacity.
Today marks the launch of The Biden Promise Tracker, which monitors the 100 most important campaign promises of President Joseph R. Biden. Biden listed the coronavirus and a variety of other health-related issues among his top priorities. You can see the entire list – including improving the economy, responding to calls for racial justice and combating climate change – here. As part of KHN’s partnership with PolitiFact, we will follow the health-related issues and then rate them on whether the promise was achieved: Promise Kept, Promise Broken, Compromise, Stalled, In the Works or Not Yet Rated. We rate the promise not on the president’s intentions or effort, but on verifiable outcomes. PolitiFact previously tracked the promises of President Donald Trump and President Barack Obama.
USE OUR CONTENT
This story can be republished for free (details).
In the U.S., someone now dies of covid every 26 seconds. And the disease is claiming more American lives each week than any other condition, ahead of heart disease and cancer, according to the Institute for Health Metrics and Evaluation at the University of Washington.
“It didn’t have to be like this, and it shouldn’t still be like this,” said Kristin Urquiza, whose father, Mark, died of covid in June, as the virus was sweeping through Phoenix.
Urquiza described it as “watching a slow-moving hurricane” tear apart her childhood neighborhood, where many people have no choice but to keep going to work and risking their health.
“I talk to dozens of strangers a day who are going through what I did in June, but the magnitude and the haunting similarities between our stories six months later is really hard,” said Urquiza, who addressed the Democratic National Convention in August. She co-founded Marked By COVID, to organize grieving families and supporters. The group calls for a faster government response and a national memorial for pandemic victims.
Given its large population, the U.S. death rate from covid remains lower than the rate in many other countries. But the death toll of 400,000 now exceeds any other country’s count — close to double what Brazil has recorded, and four times the toll in the United Kingdom.
“It’s very hard to wrap your mind around a number that is so large, particularly when we’ve had 10 months of large numbers assaulting our senses and really, really horrific images coming out of our hospitals and our morgues,” said Dr. Kirsten Bibbins-Domingo, chair of epidemiology at the University of California-San Francisco.
Scientists had long expected that wintertime could plunge the country into the deadliest months yet, but even Bibbins-Domingo wasn’t ready for the sheer pace of deaths, or the scale of the accumulated losses. The mortality burden has fallen heavily on her own state of California, which was averaging fewer than 100 deaths a day for long stretches of the pandemic, but has ranged up to more than 500 in recent days.
She said California followed the science with its handling of the pandemic, yet the devastation unfolding in places like Los Angeles reveals just how fragile any community can be.
“It’s important to understand virology. It’s important to understand epidemiology. But ultimately, what we’ve learned is that human behavior and psychology is a major force in this pandemic,” she said.
The U.S. in mid-January has averaged more than 3,300 deaths a day — well above the most devastating days of the early spring surge, when daily average deaths hovered around 2,000.
“At this point, looking at the numbers, for me the question is: Is there any way we can avoid half a million deaths before the end of February?” said Dr. Ashish Jha, dean of the Brown University School of Public Health.
“I think of how much suffering as a nation we seem to be willing to accept that we have this number of people getting infected and dying every day.”
How Did U.S. Go From 300,000 Deaths to 400,000?
The path to 400,000 deaths was painfully familiar, with patterns of sickness and death repeating themselves from earlier in the pandemic.
Deaths linked to long-term care account for more than a third of all covid deaths in the U.S. since the beginning of the pandemic. In a handful of states, long-term care contributed to half the total deaths.
Certain parts of the country have a disproportionately high death rate. Alabama and Arizona, in particular, have experienced high rates, given their populations. The virus continues to kill Black and Indigenous Americans at much higher rates than whites.
The chance of dying of covid remains much higher in rural America than in the urban centers.
People over 65 make up the overwhelming majority of deaths, but Jha said more young people are dying than earlier in the pandemic, simply because the virus is so widespread.
In this newest and grimmest chapter of the pandemic, the virus has preyed upon a public weary of restrictions and rules, and eager to mix with family and friends over the holiday season.
Like many other health workers, Dr. Panagis Galiatsatos at Johns Hopkins Hospital is now witnessing the tragic consequences in his daily rounds.
“My heart breaks, because we could have prevented this,” said Galiatsatos, an assistant professor of medicine who cares for covid patients in the intensive care unit.
“A lot of what we saw during the holiday travel was the inability to reach our loved ones or family members — not like a public service announcement, but one on one, talking to them [about the exposure risks]. … I really felt like we failed.”
Galiatsatos still recalls a grandmother who was transported six hours from her home to his hospital — because there were no beds anywhere closer. On the phone, he heard her family’s shock at her sudden passing.
“They said, ‘But she was so healthy. She cooked us all Thanksgiving dinner and we had all the family over,’” he said. “They were saying it with sincerity, but that’s probably where she got it.”
Light at the End of a Very Long Tunnel
The enormous loss of life this winter has happened, paradoxically, at a time that many hope marks the start of the final chapter of the pandemic.
A quarter of all covid deaths have happened during the five weeks since the Food and Drug Administration authorized the first vaccine.
Markel, who has written about the 1918-19 flu pandemic, said it’s estimated it killed upward of 700,000 Americans.
Of the covid pandemic, he said, “I hope we’re not talking … 600,000 or more.”
At this point, about 3 in 100 people have been vaccinated, placing America ahead of many other countries but behind the optimistic promises made in the early days of the rollout. Given the current pace of vaccination, experts warn, Americans cannot depend solely on the vaccine to prevent a crushing number of additional deaths in the coming months.
UCSF’s Bibbins-Domingo worries that the relief of knowing a vaccine will eventually be widely available — the light at the end of the tunnel — may actually lull millions more Americans into a false sense of safety.
“This tunnel is actually a very long tunnel, and the next few months, as the last few months have been, are going to be very dark times,” she said.
The emergence of more contagious variants of SARS-CoV-2, the covid virus, complicates the picture and makes it all the more imperative that Americans spend the coming months doubling down on the very same tactics — masks and physical distancing — that have kept many people safe so far.
But Jha, of Brown University, says the country now faces a different task from that of the fall, when “big behavioral changes and large economic costs” were required to prevent deaths.
“Right now what is required is getting people vaccinated with vaccines we already have,” he said. “The fact that’s going super slow still is incredibly frustrating.”
It is this dichotomy — the advent of lifesaving vaccines as hospitals are filled with more dying patients than ever before — that makes this moment in the pandemic so confounding.
“I can’t help but feel this immense somberness,” said Kristin Urquiza. “I know that a vaccine isn’t going to make a difference for the people that are in the hospital right now or who will be in the hospital next week or even next month.”
This story is from a reporting partnership with NPR.
USE OUR CONTENT
This story can be republished for free (details).
A survey by rare disease patient network Raremark found that 86% of the community members asked were interested in taking part in clinical trials. CEO Jeremy Edwards looks at how decentralised trial models can solve some of the challenges for clinical trial recruitment in rare disease.
With low and geographically dispersed patient populations in rare disease, deciding where best to place trial sites can be a headache for sponsors. Sites need to be close enough for travel, and the number of site visits and trial appointments must also be manageable for people living with the complications of having little-known and rarely-researched orphan diseases.
Decentralising trials, a topic revitalised by the COVID-19 pandemic, seems like a no-brainer, but would people with rare diseases be open to them? In fact, how do rare disease patients even feel about clinical trials? A survey of members of the Raremark community found that 86% of respondents were interested in taking part in a clinical trial now or in the future. The people who took part were from across the world, living with hemophilia, idiopathic pulmonary fibrosis, myasthenia gravis, and sickle cell disease.
Research and development will always be important to rare disease patients
This finding may come as a surprise to anyone who read this CISCRP report last year. The report found that people’s willingness to take part in clinical trials in 2020 fell dramatically compared to previous years – however that survey was conducted with the wider public while the Raremark survey focused specifically on people with rare diseases.
Progress in research and development for better treatments will always be a priority for rare disease patients. There are around 7,000 known rare diseases and only a fraction of those have treatments available.
Getting a diagnosis is not always easy; people have to battle many years because rare diseases are not as extensively researched or known about as more common ailments. Common experiences heard from people with rare diseases can be things like:
“It took me a full 10 years [to get a diagnosis]! I experienced my first symptoms when I was 12, they progressed at 13 and I got a correct diagnosis at 22.”
“No one ever knows what to do with you! It’s a pure guessing game!”
“Never heard of it before my mum was diagnosed, also nothing was actually explained to us, we found out most information on the internet!”
“I had to suffer hours of excruciating pain before I could be taken seriously.”
This illustrates the toll that having a rare disease can have on the individual and their family’s lives. This is a key reason why patients view the continued progress of research and development as important. For those participants that did not want to take part in a clinical trial, reasons given included not knowing where to start looking for information as well as the COVID-19 pandemic, hesitance about traveling and not wanting to disrupt their medication plans.
Positive patient feedback for decentralised trials
While the idea of decentralised and virtual trial methods – i.e. taking the trial to the patient, rather than the patient to the trial – has been a topic of interest for some time, COVID-19 has brought it to the forefront.
Investment into companies that offer decentralised and virtual trial solutions increased dramatically in 2020 and this is translating into practical discussions regarding the implementation of decentralised trials. With all of this in mind, Raremark was interested to learn what people with rare diseases think about them.
We asked people where they would prefer to receive their trial medication and monitoring appointments if they decided to take part in a clinical trial. 57% of participants said they would like to receive the trial medication through a mix of clinic, home, and nearby hospital visits, and 45% would like the same mix for how they are monitored during trials.
Only a few people surveyed said they wanted to have all their appointments only at the clinic or only at their home.
We also asked participants if they would have any concerns about taking part in a trial that would not require them to travel to the clinic for all their appointments – 87% of survey participants expressed no concerns about this approach to trials.
When asked about features of decentralised trial designs that people found most attractive, the top reasons given were the convenience of having more of the study take place at home and less time traveling, as well as the use of technology, both to communicate with research staff and to have their health monitored.
For the 13% of participants who did have some concerns about these types of trials, the reasons they gave for their reservations included possible adverse reactions to the drug, and not having specialists there to help them. A few others said they would struggle to comprehend all the trial literature on their own.
What does this mean for clinical trials in the future?
The COVID-19 pandemic has turned many aspects of clinical research upside down; however it will also be a powerful agent for change in the way the pharma industry conducts clinical trials. One of the barriers to uptake of virtual trials in the past has been the assumption that it requires a fully decentralised approach. We’re now seeing a shift in focus towards hybrid models where sponsors identify aspects of a trial that could be done virtually or at locations closer to patients’ homes.
Clearly, face-to-face visits will still be necessary, but through a decentralised approach these can be limited and balanced with home visits from nurses or by engaging local clinics and hospitals so some appointments can be conducted at the patient’s regular doctor’s office.
There are already tools available and more being developed that can help make decentralised trials a possibility, including software that capture patient consent easily, at home video consultation tools that make staying in contact with patients straightforward, apps for nurses to use when they’re making home visits, and even integrated wearable devices that collect the relevant data needed for a trial such as biomarker data, physical activity and motor symptoms.
Adopt a person-first approach to increase engagement and retention
The best way to keep people engaged in trials and reduce trial dropouts is taking a person-first, approach.
It is essential to remember that the people who take part in clinical trials may have jobs, work or childcare commitments, or the nature of their disease may mean certain tasks take priority over others.
To keep people living with rare diseases engaged, clinical trials must adapt to fit as seamlessly as possible into people’s lives. Decentralised and hybrid trial models can help by removing obstacles that people may find disruptive to their everyday life when taking part in a trial, such as the burden of traveling to trial sites multiple times.
Additionally, there are several ways to keep the people who opted to participate interested and engaged, whether a decentralised approach is adopted. These include access to information and keeping communication lines open before, during and after a trial.
Participants should always feel comfortable asking questions and voicing concerns, so it is important to use every opportunity to keep people informed and treat their time and commitment with respect.
A few simple ways to achieve this include:
- Replying to patient emails and call-backs promptly – there’s nothing worse than spending lots of time looking for patients only to lose them because of a missed call
- Catering for work schedules, planning calls and screening appointments accordingly – remember patients have lives too.
- Addressing any anxieties patients and caregivers have, including coming off existing medication, as well as questions regarding the trial drug or the tests and procedures involved in the trial.
Shifting towards decentralised trial designs can help solve some of the challenges around recruiting patients for orphan drug trials. Designing trials where participants do not have to travel as often and where some appointments can be done virtually will make them more convenient and cause less disruption to people’s lives. Rare disease patients are open to these trial types but still need some in-person appointments, therefore a hybrid approach with a mix of in-person and virtual appointments is desirable.
Ultimately, by understanding the world that rare disease patients are living in and designing trials accordingly, sponsors can significantly improve clinical trial engagement and participation.
You can learn more about our findings and the opinions around clinical trials in rare disease here.
About the author
Jeremy Edwards is the CEO of Raremark. He has been focused on aiding the biopharmaceutical and health sciences industry in the development of key compounds and new therapies for over 25 years. His background includes executive leadership positions across the clinical development continuum; from full-service CROs, to highly specialised imaging modalities, to niche patient-focused service providers.
The post Unlocking the potential in rare disease research with decentralised trials appeared first on .
Supplies of COVID-19 vaccines are in the spotlight as countries across the world step up their immunisation campaigns against the pandemic.
As vaccine manufacturers face unprecedented demand for their newly approved products, the race is on to provide enough shots for billions of people across the world.
Pfizer and BioNTech have responded to this by upgrading their manufacturing facility in Puurs, Belgium.
The companies said that this will result in a temporary reduction in the number of doses delivered in the upcoming week in the European Union.
Normal production will resume next week, while deliveries will increase from the week of 15th February.
This will allow the companies to deliver the quantities of vaccine doses the company has committed to in the first quarter and “significantly more” in the second quarter.
They will announce further updates about European vaccine supplies and the companies said they are planning to add more vaccine suppliers and contract manufacturers to boost worldwide capacity.
Meanwhile, the World Health Organization (WHO) has slammed the unequal distribution of coronavirus vaccines, where richer countries have been prioritised over poorer countries.
WHO director general Tedros Adhanom Gehbreyesus said in a briefing that vaccine policies had resulted in a “catastrophic moral failure”.
Over 39 million doses have been distributed across 49 high-income countries, but just 25 doses have been administered in only one of the lowest-income countries.
For those participants that did not want to take part in a clinical trial, reasons given included not knowing where to start looking for information as well as the COVID-19 pandemic, hesitance about traveling and not wanting to disrupt their medication plans.
Vaccines have been developed by companies based in China, India, Russia, the UK and the US, often with help from government funding.
Those countries have prioritised distribution to their own population, scrambling to place millions of orders with various manufacturers as the pandemic took hold last year.
Dr Tedros said this approach would result in increased prices and encourage hoarding.
He said: “I need to be blunt: the world is on the brink of a catastrophic moral failure – and the price of this failure will be paid with lives and livelihoods in the world’s poorest countries.”
“Ultimately, these actions will only prolong the pandemic, the restrictions needed to contain it, and human and economic suffering,” he added.
He called for a full commitment to the global vaccine-sharing scheme Covax, which is due to kick in next month.
More than 180 countries have signed up to the initiative, which is supported by the WHO and a group of vaccine advocacy group.
It will fund vaccinations for 92 low or middle-income countries and two billion doses are already on order.
In Europe, roll-out of COVID-19 vaccine has been criticised for being too slow.
Writing in the Guardian, Hans-Werner Sinn, professor of economics at the University of Munich, said that the EU had failed to buy enough shots of the Pfizer/BioNTech vaccine early in the pandemic because of “institutional inflexibility”.
Feature image courtesy of Rocky Mountain Laboratories/NIH
The post COVID-19 vaccine supplies in spotlight as immunisation campaigns kick in appeared first on .
- The company to initiate the clinical trial assessing the safety and efficacy of its COVID-19 drug based on the Grifols’ immunoglobulin Gamunex-C and containing anti-SARS-CoV-2 polyclonal Abs from plasma donors who have recovered from the disease
- The study is expected to be initiated in Feb’2021. The treatment will be administered in primary care centers in people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination
- The Grifols immunoglobulin Gamunex-C (IV, IM, SC) has proven to be safe and efficacious in the prevention of diverse infectious diseases in an immunocompromised patient
Click here to read full press release/ article | Ref: PRNewswire | Image: Yicai Global
The post Grifols to Evaluate New Immunoglobulin Therapy Against COVID-19 in Spain first appeared on PharmaShots.
One key factor, is that we should the vaccine to the people most at risk for the disease. In this case, our ranking (R) is just a function of people’s mortality risk conditional on getting COVID-19. Older individuals and those in nursing homes are at much higher risk. Thus, we should vaccinate based on how likely people are to die if they get COVID
R = f[mortality]
However, fairness is also important. Front line health care workers are putting their lives on the line to treat patients with COVID and should also be prioritized. Let’s make sure that fairness considerations are included. I’ll update our prioritization as follows: where both mortality and fairness matter. Of course we’ll have to weigh these priorities, but we can worry about that later. The relative weighting coefficient’s I’ll include with the vector θ.
R = f[mortality, fairness; θ]
Getting back to mortality, previously, we (implicitly) noted that older people are at higher risk of dying if they get COVID. But so are younger people such as those with comoribidities such as asthma or COPD. Thus, let’s be a bit more specific on the factors that affect mortality.
R = f[mortality(age, nursing home, comorbidities),fairness; θ]
We focus on the risk of people dying conditional on getting COVID-19. In practice, however, the chance of getting COVID-19 may depend on individual behavior. Older people may be more cautious and less likely to leave the house or travel than younger individuals., especially if they are retired and do not need to work As younger individuals have less health risk and will need to work as they have less savings, they may be more likely to engage in risky behaviors and spread COVID-19. Thus, we’ll want to focus on likelihood of getting COVID-19 or the cost of staying at home. We will update the scoring to incorporate COVID-19 incidence and cost of isolation as follows:
R = f[mortality(age, nursing home, comorbidities), fairness,incidence,cost of isolation; θ]
Now we’re getting closer. However, the vaccinating people in rural areas may be more challenging than those in urban areas. Those in urban areas come into contact with more people and are more likely to spread the disease. Let’s add that dimension to our ranking formula.
R = f[mortality(age, nursing home, comorbidities), fairness,incidence,cost of isolation, urban; θ]
Now we have the perfect system…once we figure out θ.
But wait! The cost of figuring out each individuals risk score will require an army of statisticians at each vaccination site or at a minimum a data entry team that can feed each individual’s characteristics into a computers algorithm to calculate each person’s priority score.
Hmmm, this is becoming become problematic. In fact, California experienced problems with vaccination due to their complex tiering structure. Perhaps our focus on prioritization is missing the point: let’s get people vaccinated fast! Maybe the Israeli approach of vaccinating everyone 65 and older first, and then everyone else is the right way to go. Perhaps we should follow Voltaire’s advice:
Dans ses écrits, un sage Italien
Dit que le mieux est l’ennemi du bien.
[In his writings, a wise Italian
says that the best is the enemy of the good]
Public health authorities in California are seeking a halt on dosing of one lot of Moderna’s COVID-19 vaccine after reports of allergic reactions at one immunisation clinic.
According to state epidemiologist Dr Erica Pan, there were a higher-than-expected number of suspected allergic reactions at a community clinic being used to administer the shot, with some people needing medical attention in a 24-hour period.
For now there is little information about the Moderna vaccine reactions, other than they are centred around a specific manufacturing lot – number 041L20A – and that “fewer than 10” cases of allergic reactions were reported.
More than 330,000 doses from that lot have already been administered in California since the start of the vaccine roll-out, according to state department of public health. The clinic in question switched to another lot of Moderna vaccine after closing for a few hours.
There were also reports of allergic reactions during the initial roll-out of the Pfizer/BioNTech vaccine, including some cases of anaphylaxis, which also resulted in a temporary pause in dosing at some centres.
Last week, the Centers for Disease Control and Prevention (CDC) published new data which identified 21 cases of anaphylaxis after administration of a reported 1.9 million first doses of the Pfizer/BioNTech shot, mainly within 15 minutes of the injection.
That was equivalent to 11 cases per million doses, according to the agency, which says the reactions can be managed using patient screening for allergies, observation periods after dosing and having epinephrine injections on hand as a precaution.
Both the Pfizer/BioNTech and Moderna vaccines are based on mRNA and use an excipient – called polyethylene glycol (PEG) – that some scientists suggest could be responsible for the allergic reactions, according to a report in the journal Science.
“Our goal is to provide the COVID vaccine safely, swiftly and equitably,” said Dr Pan in a statement.
“Out of an extreme abundance of caution and also recognising the extremely limited supply of vaccine, we are recommending that providers use other available vaccine inventory and pause the administration of vaccines from Moderna lot 041L20A until the investigation by the CDC, FDA, Moderna and the state is complete.
While no vaccine or medical procedure is without risk, the risk of a serious adverse reaction is very small, according to the department. At last count, California had recorded almost 3 million COVID-19 cases, with just over 33,000 deaths, placing it among the worst affected states in the US.
The post Allergic reactions prompt Moderna COVID vaccine pause in California appeared first on .
Karina Malhotra from Acumentice explores how digital tech and data could help address the NHS elective care backlog in 2021 and beyond.
The repercussions of the COVID-19 pandemic are going to take a considerable time to repair and nowhere is this more pertinent than in NHS elective care.
The impact on elective care has been considerable. Reports have shown that the number of people waiting more than a year for an operation has reached its highest level since 2008. According to NHS figures, in September 2020 139,545 patients in England had been waiting more than 12 months for surgery such as a hip and knee replacement or cataract removals. These waits have worsened with the winter period and some hospitals are already cancelling planned operations. Under the NHS constitution, everyone needing non-urgent treatment should get it within 18 weeks. This has posed two challenges – clearing the existing and growing backlog and instigating better systems and processes in doing so to prevent the same problem repeating in the future.
While extended waiting times have sometimes been pitched as a problem created by COVID, but that is only partially true. Even before the pandemic, there were around 4.4m people on the NHS waiting list and although the majority – around 80% – of patients were treated within the 18 week constitution, it had been falling short of the 92% target set by the government for some time.
There are many factors at play driving this. We’ve seen extreme seasonal cycles of weather for several years now, which has upped demand for all services like ambulance, A&E and mental health care. Services used, in some regard, by pretty much every societal section. This has been compounded with the looming spectre of Brexit, which has meant the NHS lost some of its valuable workforce from overseas. Fast forward to March 2020 and the vast majority of elective activity was suspended due to COVID, massively adding to an existing backlog.
While the pandemic exacerbated historical issues, it also underlined that NHS can respond to a crisis and isn’t static, as is the widely-held perception. In moving into Phase III, it was asked to reach 80% of previous activity levels by the end of September, and in some areas they exceeded those targets.
The bluntness of targets
The answer to the capacity issue has, historically, been to increase efficiency and throughput – more people, smaller space, shorter time. Of course, in a world of social distancing and infection prevention and control, we’re now doing exactly the opposite. This, combined with the fact that existing metrics and processes for monitoring elective care performance may no longer be fit for purpose means a new approach is required.
Reverting to type is not an option and both clinicians and healthcare providers must find ways of treating those patients at most risk of harm in sufficient numbers to make a difference without simply working down a checklist to hit a target. It’s something the Royal College of Surgeons has called for – to not look at targets but look at the patients and what they need as individuals. As an example, Professor Catherine Urch has taken this approach and enhanced it at Imperial NHS Trust to include a measure for retrospective and prospective harm that may arise as a result of awaiting time to guide the decision further.
The key principle being that there’s huge variation between patients that need to be seen very quickly versus those that can wait and that the healthcare sector as a whole has to be mature and realistic about managing the huge numbers of diagnostics interventions, outpatients and treatments. The culmination of which is a very different lens to look at the clinical picture. It would mean not trying to meet a generic population within a given time period but instead, match the individual patient need against a population-driven set of priorities.
Critical to the success of this approach will be to engage clinicians in what is traditionally perceived to be an administrative function. We must enable them to bring their expertise and knowledge of their patient to the table, and allow them greater jurisdiction over the movement of patients rather than a next-cab-off-the-rank scenario. We have to be focusing on using our limited resources for the maximum value for those individual patients and a more clinically driven approach to doing that can only be a good thing.
Dealing in data quality
Thankfully, the NHS has proven itself to be an incredible innovator. We’ve seen more collaboration and adoption of new tools and technologies than ever before. That said, one area that remains ripe for disruption isn’t the waiting list process itself, but the quality of data on it. These lists contain thousands of names and if some of those are inaccurate or no longer required, it places much greater significance on the coveted appointment slots for the patients that genuinely need them.
However, unlike sweeping changes to attitudes and the core process of prioritising patients, improving data quality by using digital tools such that the manual work is reduced is something of a no-brainer. There are many examples where this is happening already. For instance, our partners at Imperial are using a ‘smart’ software (Qubit) to automate data quality correction and validation saving 35,000 manual hours of work annually. It is also worth noting that the clinical prioritisation and review process that we’ve supported implementation of at Imperial has seen an improvement in clinical engagement, which has resulted in improved data quality on waiting lists. Clinicians can decide what’s important for their patients, and how long they should wait whilst addressing any inaccurate waiting list entries of patients not requiring treatment, leading to a 10% to 15% improvement in waiting list data quality.
All of these innovations are key because losing patients in the system or increasing the number of incorrect entries on the waiting list are the worst thing that could happen at this time. The balancing item is ensuring we have full-scale engagement with the patients – the people who ultimately pay for and are the beneficiaries of the services that we provide.
Capitalising on the rest opportunity
There is no doubt COVID has brought major challenges to the NHS but it has simultaneously exposed valuable learnings and it is critical we use the reset opportunity that has been given to us. It is clear that change is needed and we have to do things more efficiently, more effectively and more innovatively because even if we combine capacity in the NHS and independent sector, we still don’t have the capacity to achieve the current targets.
The last 12 months have highlighted that we’ve got to have transparent and honest relationships with the people that we are actually here to serve. This has to be the bedrock of a future where lengthy elective care waiting lists are a thing of the past.
About the author
Acumentice founder Karina Malhotra is a former NHS director and senior leader, with extensive experience and subject matter expertise in all aspects of elective care management. She has provided expert advisory support to executive teams at some of the UK’s largest Trusts. Karina founded Acumentice in 2014, with a view to share this expertise through the development of clear and sustainable methodologies and frameworks.
The post The elective care conundrum – can digital innovation help? appeared first on .
A promise by president-elect Joe Biden to carry out 100 million coronavirus vaccinations in his first 100 days in power is “absolutely doable”, according to the US leading infectious diseases expert Dr Anthony Fauci.
Biden has announced ambitious initiatives to fight COVID-19 ahead of his inauguration, which is due to take place on Wednesday.
While Biden’s team acknowledges that it is a steep challenge, it’s received the backing of Fauci, who is optimistic that two new vaccines from AstraZeneca and Johnson & Johnson could be approved in the US in the next few weeks.
So far only 12 million people have received vaccines in the US.
This would add to the Pfizer/BioNTech and Moderna mRNA-based shots that already have emergency approval in the US.
The US has been severely affected by the pandemic, with figures recorded on Sunday morning showing 23,760,523 cases and 395,855 deaths had been recorded by Johns Hopkins University in the US.
Fauci, director of the US-government funded National Institute of Allergy and Infectious Diseases (NIAID), told NBC’s Meet the Press that “it’s going to take a while to turn this around.”
He added: “I can tell you one thing that’s clear is that the issue of getting 100 million doses in the first 100 days, is absolutely a doable thing.”
Biden can invoke the Defense Production Act to boost supplies of the vaccine, Fauci added.
“But the feasibility of his goal is absolutely clear, there’s no doubt about it. That can be done.”
On the vaccines from J&J and AZ, Fauci said: “I would imagine within a period of a week or so, or at the most a couple of weeks, they’re going to be getting their data together and showing it to the [FDA].
“They’re going to have to get their data and safety monitoring board to look at it to see if it is appropriate to start, you know, essentially putting the package together to get an Emergency Use Authorization. But we’re weeks away, not months away, for sure.”
The post Fauci backs Biden’s plan for 100 million COVID-19 shots appeared first on .
The post ‘It’s not too bad to miss Canadian winter:’ Voluntourism adapting to pandemic appeared first on Healthy Debate.
One solution to this issue would be to increase vaccination rates across the board. However, according to a survey in November, minorities are less interested in getting COVID-19 vaccinations compared to Whites.
Much progress is needed to get people vaccinated quickly. Israel’s success may provide some learnings on how to get more people vaccinated, fast!
About 3% of Americans have received at least one dose of a coronavirus vaccine so far. But in 16 states that have released data by race, white residents are being vaccinated at significantly higher rates than Black residents, according to the analysis — in many cases two to three times higher.
In the most dramatic case, 1.2% of white Pennsylvanians had been vaccinated as of Jan. 14, compared with 0.3% of Black Pennsylvanians.
The vast majority of the initial round of vaccines has gone to health care workers and staffers on the front lines of the pandemic — a workforce that’s typically racially diverse made up of physicians, hospital cafeteria workers, nurses and janitorial staffers.
If the rollout were reaching people of all races equally, the shares of people vaccinated whose race is known should loosely align with the demographics of health care workers. But in every state, Black Americans were significantly underrepresented among people vaccinated so far.
Access issues and mistrust rooted in structural racism appear to be the major factors leaving Black health care workers behind in the quest to vaccinate the nation. The unbalanced uptake among what might seem like a relatively easy-to-vaccinate workforce doesn’t bode well for the rest of the country’s dispersed population.
Black, Hispanic and Native Americans are dying from covid at nearly three times the rate of white Americans, according to a Centers for Disease Control and Prevention analysis. And non-Hispanic Black and Asian health care workers are more likely to contract covid and to die from it than white workers. (Hispanics can be of any race.)
“My concern now is if we don’t vaccinate the population that’s highest-risk, we’re going to see even more disproportional deaths in Black and brown communities,” said Dr. Fola May, a UCLA physician and health equity researcher. “It breaks my heart.”
Dr. Taison Bell, a University of Virginia Health System physician who serves on its vaccination distribution committee, stressed that the hesitancy among some Blacks about getting vaccinated is not monolithic. Nurses he spoke with were concerned it could damage their fertility, while a Black co-worker asked him about the safety of the Moderna vaccine since it was the company’s first such product on the market. Some floated conspiracy theories, while other Black co-workers just wanted to talk to someone they trust like Bell, who is also Black.
Dose 2 is in! Just some mild arm soreness that will probably be worse tomorrow. I’ll check in tomorrow to give an update. h/t: @gradydoctor for the T-shirt idea#RightToBareArms 💪🏾 💉 #ShotOfHope#BlackMenInMedicine pic.twitter.com/56jAu0V5zy
— Dr. Taison Bell (@TaisonBell) January 5, 2021
But access issues persist, even in hospital systems. Bell was horrified to discover that members of environmental services — the janitorial staff — did not have access to hospital email. The vaccine registration information sent out to the hospital staff was not reaching them.
“That’s what structural racism looks like,” said Dr. Georges Benjamin, executive director of the American Public Health Association. “Those groups were seen and not heard — nobody thought about it.”
UVA Health spokesperson Eric Swenson said some of the janitorial crew were among the first to get vaccines and officials took additional steps to reach those not typically on email. He said more than 50% of the environmental services team has been vaccinated so far.
A Failure of Federal Response
As the public health commissioner of Columbus, Ohio, and a Black physician, Dr. Mysheika Roberts has a test for any new doctor she sees for care: She makes a point of not telling them she’s a physician. Then she sees if she’s talked down to or treated with dignity.
That’s the level of mistrust she says public health officials must overcome to vaccinate Black Americans — one that’s rooted in generations of mistreatment and the legacy of the infamous Tuskegee syphilis study and Henrietta Lacks’ experience.
A high-profile Black religious group, the Nation of Islam, for example, is urging its members via its website not to get vaccinated because of what Minister Louis Farrakhan calls the “treacherous history of experimentation.” The group, classified as a hate group by the Southern Poverty Law Center, is well known for spreading conspiracy theories.
Public health messaging has been slow to stop the spread of misinformation about the vaccine on social media. The choice of name for the vaccine development, “Operation Warp Speed,” didn’t help; it left many feeling this was all done too fast.
Benjamin noted that while the nonprofit Ad Council has raised over $37 million for a marketing blitz to encourage Americans to get vaccinated, a government ad campaign from the Health and Human Services Department never materialized after being decried as too political during an election year.
“We were late to start the planning process,” Benjamin said. “We should have started this in April and May.”
And experts are clear: It shouldn’t merely be ads of famous athletes or celebrities getting the shots.
“We have to dig deep, go the old-fashioned way with flyers, with neighbors talking to neighbors, with pastors talking to their church members,” Roberts said.
Speed vs. Equity
Mississippi state Health Officer Dr. Thomas Dobbs said that the shift announced Tuesday by the Trump administration to reward states that distribute vaccines quickly with more shots makes the rollout a “Darwinian process.”
Dobbs worries Black populations who may need more time for outreach will be left behind. Only 18% of those vaccinated in Mississippi so far are Black, in a state that’s 38% Black.
It might be faster to administer 100 vaccinations in a drive-thru location than in a rural clinic, but that doesn’t ensure equitable access, Dobbs said.
“Those with time, computer systems and transportation are going to get vaccines more than other folks — that’s just the reality of it,” Dobbs said.
In Washington, D.C, a digital divide is already evident, said Dr. Jessica Boyd, the chief medical officer of Unity Health Care, which runs several community health centers. After the city opened vaccine appointments to those 65 and older, slots were gone in a day. And Boyd’s staffers couldn’t get eligible patients into the system that fast. Most of those patients don’t have easy access to the internet or need technical assistance.
“If we’re going to solve the issues of inequity, we need to think differently,” Boyd said.
Dr. Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials, said the limited supply of vaccine must also be considered.
“We are missing the boat on equity,” he said. “If we don’t step back and address that, it’s going to get worse.”
While Plescia is heartened by President-elect Joe Biden’s vow to administer 100 million doses in 100 days, he worries the Biden administration could fall into the same trap.
And the lack of public data makes it difficult to spot such racial inequities in real time. Fifteen states provided race data publicly, Missouri did so upon request, and eight other states declined or did not respond. Several do not report vaccination numbers separately for Native Americans and other groups, and some are missing race data for many of those vaccinated. The CDC plans to add race and ethnicity data to its public dashboard, but CDC spokesperson Kristen Nordlund said it could not give a timeline for when.
One-third of Black adults in the U.S. said they don’t plan to get vaccinated, citing the newness of the vaccine and fears about safety as the top deterrents, according to a December poll from KFF. (KHN is an editorially independent program of KFF.) Half of them said they were concerned about getting covid from the vaccine itself, which is not possible.
Experts say this kind of misinformation is a growing problem. Inaccurate conspiracy theories that the vaccines contain government tracking chips have gained ground on social media.
Just over half of Black Americans who plan to get the vaccine said they’d wait to see how well it’s working in others before getting it themselves, compared with 36% of white Americans. That hesitation can even be found in the health care workforce.
“We shouldn’t make the assumption that just because someone works in health care that they somehow will have better information or better understanding,” Bell said.
In Colorado, Black workers at Centura Health were 44% less likely to get the vaccine than their white counterparts. Latino workers were 22% less likely. The hospital system of more than 21,000 workers is developing messaging campaigns to reduce the gap.
“To reach the people we really want to reach, we have to do things in a different way, we can’t just offer the vaccine,” said Dr. Ozzie Grenardo, a senior vice president and chief diversity and inclusion officer at Centura. “We have to go deeper and provide more depth to the resources and who is delivering the message.”
That takes time and personal connections. It takes people of all ethnicities within those communities, like Willy Nuyens.
Nuyens, who identifies as Hispanic, has worked for Kaiser Permanente Los Angeles Medical Center for 33 years. Working on the environmental services staff, he’s now cleaning covid patients’ rooms. (KHN is not affiliated with Kaiser Permanente.)
In Los Angeles County, 92% of health care workers and first responders who have died of covid were nonwhite. Nuyens has seen too many of his co-workers lose family to the disease. He jumped at the chance to get the vaccine but was surprised to hear only 20% of his 315-person department was doing the same.
So he went to work persuading his co-workers, reassuring them that the vaccine would protect them and their families, not kill them.
“I take two employees, encourage them and ask them to encourage another two each,” he said.
So far, uptake in his department has more than doubled to 45%. He hopes it will be over 70% soon.
USE OUR CONTENT
This story can be republished for free (details).
The post Things to Consider When You are Making Your Own Scrubs appeared first on Pharma Mirror Magazine.
Así y todo, South dice que no tiene apuro por dejar de usar máscara
“Honestamente, no creo que vuelva a estar sin máscara en el trabajo”, dijo South, quien es directora del Urban Health Lab de la Universidad de Pennsylvania en Philadelphia. “No creo que me sentiría segura”.
Aunque las vacunas contra covid son altamente efectivas, South planea seguir usando máscara dentro y fuera del hospital.
Expertos en salud dicen que hay buenas razones para seguir el ejemplo de esta doctora.
“El uso de máscaras y el distanciamiento social deberán continuar en el futuro, hasta que tengamos cierto nivel de inmunidad colectiva”, dijo el doctor Preeti Malani, oficial de salud jefe de la Universidad de Michigan. “Las máscaras y el distanciamiento están aquí para quedarse”.
Malani y otros expertos en salud explican cinco razones:
- Ninguna vacuna es 100% efectiva
Extensos ensayos clínicos hallaron que dos dosis de las vacunas de Moderna y Pfizer-BioNTech prevenían el 95% de las enfermedades causadas por el coronavirus. Si bien esos resultados son impresionantes, 1 de cada 20 personas queda desprotegida, dijo el doctor Tom Frieden, ex director de los Centros para el Control y Prevención de Enfermedades (CDC).
Malani señala que las vacunas se probaron en ensayos clínicos controlados, en los mejores centros médicos, en condiciones óptimas.
Pero en el mundo real, las vacunas suelen ser un poco menos efectivas. Los científicos usan términos específicos para describir el fenómeno. Se refieren a la protección que ofrecen las vacunas en los ensayos clínicos como “eficacia”, mientras que la inmunidad real que se obvserva en la población vacunada es “efectividad”.
La efectividad de las vacunas contra covid podría verse afectada por la forma en que se manipulan, observó Malani. El material genético utilizado en las vacunas elaboradas con ARN mensajero del coronavirus es tán frágil que debe almacenarse y transportarse con cuidado.
Cualquier variante que no siga la guía de manejo de vacunas de los CDC podría influir en su funcionamiento, explicó Malani.
- Las vacunas no brindan protección inmediata
Malani explicó que ninguna vacuna ofrece protección apenas la persona se vacuna. El sistema inmunológico tarda aproximadamente dos semanas en producir anticuerpos que bloquean las infecciones virales.
Las vacunas contra covid, sin embargo, tardarán un poco más que otras porque tanto la de Pfizer como la de Moderna, requieren de dos dosis. Las dosis de Pfizer se administran con tres semanas de diferencia, las de Moderna, con cuatro semanas.
Es decir que no habrá protección completa hasta cinco o seis semanas después de la primera dosis. Una persona que se vacunó el día de Año Nuevo no estará completamente protegida hasta el día de San Valentín.
- Es posible que las vacunas no impidan propagar el virus
Las vacunas pueden poporcionar dos niveles de protección. Por ejemplo, la vacuna contra el sarampión previene que el virus infecte un organismo, por lo que las personas vacunadas no transmiten la infección ni desarrollan síntomas.
La mayoría de las otras vacunas, como la de la gripe, evitan que las personas se enfermen pero no que se infecten o transmitan el virus a otros, explicó el doctor Paul Offit, asesor de los Institutos Nacionales de Salud (NIH) y de la Administración de Drogas y Alimentos (FDA) sobre las vacunas contra covid.
Si bien las vacunas contra covid claramente previenen la enfermedad, los científicos necesitan más tiempo para descubrir si también previenen la transmisión, dijo Saskia Popescu, epidemióloga con sede en Phoenix y profesora asistente en el programa de biodefensa de la Escuela Schar de Gobierno y Políticas de la Universidad George Mason.
“Todavía no sabemos si la vacuna protege contra la infección o solo contra la enfermedad”, dijo Frieden, quien ahora es director ejecutivo de Resolve to Save Lives, una iniciativa mundial de salud pública. “En otras palabras, una persona vacunada podría transmitir el virus, incluso si no se siente enferma”.
Hasta que los investigadores puedan responder esta pregunta, usar cubrebocas es la forma más segura para que las personas vacunadas protejan a quienes las rodean.
- Las máscaras protegen a personas con sistemas inmunitarios comprometidos
Las personas con cáncer tienen un riesgo particular de contraer covid. Estudios han mostrado que son más propensos a infectarse y a morir a causa del coronavirus. Y es posible que las vacunas no los protejan dijo el doctor Gary Lyman, profesor del Centro de Investigación del Cáncer Fred Hutchinson.
Los pacientes con cáncer son vulnerables en muchos aspectos. Las personas con cáncer de pulmón son menos capaces de combatir una neumonía, y los que están bajo quimioterapia o radioterapia tienen sistemas inmunes debilitados. La leucemia y el linfoma atacan directamente las células inmunitarias, lo que dificulta que los pacientes combatan el virus.
Lyman dijo que no se sabe cómo reaccionarán a la vacuna los pacientes oncológicos, porque fueron excluidos de los ensayos clínicos. A solo unos pocos participantes se les diagnóstico cáncer después de inscribirse. En este grupo, la protección de las vacunas solo fue del 76%.
“Por ahora, debemos asumir que los pacientes con cáncer pueden no experimentar el 95% de eficacia”, completó Lyman.
También hay algunas personas alérgicas que no pueden vacunarse.
Usar máscaras también ayuda a proteger a estos grupos más vulnerables.
- Las máscaras protegen contra cualquier cepa del coronavirus, la original y las nuevas mutaciones
Hasta ahora, los estudios sugieren que las vacunas protegerán contra estas cepas. Pero es claro, según explicó Frieden, que los cubrebocas, la distancia física y medidas como evitar multitudes protegen contra todas las formas del virus, y de otros virus respiratorios.
Por ejemplo, los casos de gripe bajaron dramáticamente en todo el mundo desde que se implementaron las cuarentenas y el uso de máscaras.
Lo ideal es combinar las vacunas con las máscaras y el distanciamiento, para poner fin a la pandemia, dijo Offit. “Los tres enfoques funcionan mejor en equipo”.
USE OUR CONTENT
This story can be republished for free (details).
J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month.
The UK has caused controversy in recent weeks by tinkering with the dosing regimens for coronavirus vaccines from AstraZeneca and Pfizer/BioNTech, which are being rolled as part of the country’s mass vaccination programme.
Both of these vaccines require two doses, as does the most recently approved shot from Moderna, which is due to arrive in the UK in the spring.
In order to make the best use of scarce vaccine resources the UK has opted to extend the time between doses to up to 12 weeks, a strategy that has been criticised by some scientists who are fearful that it could cause vaccine-tolerant strains of the virus to emerge.
Johnson & Johnson’s Janssen pharma unit is further behind in the development of its vaccine, which has the crucial advantage of being administered in a single shot.
The UK government has an order of 30 million doses of the vaccine from J&J and an option for an additional 22 million doses in an agreement signed last summer.
Latest data give hope that the vaccine could be added to the campaign after phase 1/2a data showed that the shot provided an immune response that lasted for at least 71 days, the duration of time measured in the study involving patients aged 18-55 years.
The phase 1/2a interim analysis showed that the Company’s COVID-19 vaccine candidate induced an immune response and was generally well-tolerated across all study participants.
Data demonstrated that, after a single vaccination, neutralising antibodies against COVID-19 were detected in over 90% of study participants at day 29 and 100% of participants aged 18-55 years at day 57.
These neutralising antibodies remained stable through day 71, currently the latest timepoint available in this ongoing study.
Data on durability of immune responses in trial participants aged over 65 years will be available in late January and longer-term follow-up to one year is planned.
Top line data from a phase 3 study is due later this month, although this timing may change due to disease events.
J&J expects to file with the FDA first, followed by other regulators. The European Medicines Agency is conducting a rolling review of the vaccine to speed up the process.
The post J&J single-shot COVID-19 vaccine shows early promise appeared first on .
As of Thursday, more than 4.7 million doses of the Pfizer-BioNTech and Moderna covid vaccines had been allocated to the federal pharmacy partnership, which has deputized pharmacy teams from Walgreens and CVS to vaccinate nursing home residents and workers. Since the program started in some states on Dec. 21, however, they have administered about one-quarter of the doses, according to the Centers for Disease Control and Prevention.
Across the country, some nursing home directors and health care officials say the partnership is actually hampering the vaccination process by imposing paperwork and cumbersome corporate policies on facilities that are thinly staffed and reeling from the devastating effects of the coronavirus. They argue that nursing homes are unique medical facilities that would be better served by medical workers who already understand how they operate.
Mississippi’s state health officer, Dr. Thomas Dobbs, said the partnership “has been a fiasco.”
The state has committed 90,000 vaccine doses to the effort, but the pharmacies had administered only 5% of those shots as of Thursday, Dobbs said. Pharmacy officials told him they’re having trouble finding enough people to staff the program.
Dobbs pointed to neighboring Alabama and Louisiana, which he says are vaccinating long-term care residents at four times the rate of Mississippi.
“We’re getting a lot of angry people because it’s going so slowly, and we’re unhappy too,” he said.
Many of the nursing homes that have successfully vaccinated willing residents and staff members are doing so without federal help.
For instance, Los Angeles Jewish Home, with roughly 1,650 staff members and 1,100 residents on four campuses, started vaccinating Dec. 30. By Jan. 11, the home’s medical staff had administered its 1,640th dose. Even the facility’s chief medical director, Noah Marco, helped vaccinate.
The home is in Los Angeles County, which declined to participate in the CVS/Walgreens program. Instead, it has tasked nursing homes with administering vaccines themselves, and is using only Moderna’s easier-to-handle product, which doesn’t need to be stored at ultracold temperatures, like the Pfizer vaccine. (Both vaccines require two doses to offer full protection, spaced 21 to 28 days apart.)
By contrast, Mariner Health Central, which operates 20 nursing homes in California, is relying on the federal partnership for its homes outside of L.A. County. One of them won’t be getting its first doses until next week.
“It’s been so much worse than anybody expected,” said the chain’s chief medical officer, Dr. Karl Steinberg. “That light at the end of the tunnel is dim.”
Nursing homes have experienced some of the worst outbreaks of the pandemic. Though they house less than 1% of the nation’s population, nursing homes have accounted for 37% of deaths, according to the COVID Tracking Project.
Facilities participating in the federal partnership typically schedule three vaccine clinics over the course of nine to 12 weeks. Ideally, those who are eligible and want a vaccine will get the first dose at the first clinic and the second dose three to four weeks later. The third clinic is considered a makeup day for anyone who missed the others. Before administering the vaccines, the pharmacies require the nursing homes to obtain consent from residents and staffers.
Despite the complaints of a slow rollout, CVS and Walgreens said they’re on track to finish giving the first doses by Jan. 25, as promised.
“Everything has gone as planned, save for a few instances where we’ve been challenged or had difficulties making contact with long-term care facilities to schedule clinics,” said Joe Goode, a spokesperson for CVS Health.
Dr. Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials, acknowledged some delays through the partnership, but said that’s to be expected because this kind of effort has never before been attempted.
“There’s a feeling they’ll get up to speed with it and it will be helpful, as health departments are pretty overstretched,” Plescia said.
But any delay puts lives at risk, said Dr. Michael Wasserman, the immediate past president of the California Association of Long Term Care Medicine.
“I’m about to go nuclear on this,” he said. “There should never be an excuse about people not getting vaccinated. There’s no excuse for delays.”
Bringing in Vaccinators
Nursing homes are equipped with resources that could have helped the vaccination effort — but often aren’t being used.
Most already work with specialized pharmacists who understand the needs of nursing homes and administer medications and yearly vaccinations. These pharmacists know the patients and their medical histories, and are familiar with the apparatus of nursing homes, said Linda Taetz, chief compliance officer for Mariner Health Central.
“It’s not that they aren’t capable,” Taetz said of the retail pharmacists. “They just aren’t embedded in our buildings.”
If a facility participates in the federal program, it can’t use these or any other pharmacists or staffers to vaccinate, said Nicole Howell, executive director for Ombudsman Services of Contra Costa, Solano and Alameda counties.
But many nursing homes would like the flexibility to do so because they believe it would speed the process, help build trust and get more people to say yes to the vaccine, she said.
Howell pointed to West Virginia, which relied primarily on local, independent pharmacies instead of the federal program to vaccinate its nursing home residents.
The state opted against the partnership largely because CVS/Walgreens would have taken weeks to begin shots and Republican Gov. Jim Justice wanted them to start immediately, said Marty Wright, CEO of the West Virginia Health Care Association, which represents the state’s long-term care facilities.
The bulk of the work is being done by more than 60 pharmacies, giving the state greater control over how the doses were distributed, Wright said. The pharmacies were joined by Walgreens in the second week, he said, though not as part of the federal partnership.
“We had more interest from local pharmacies than facilities we could partner them up with,” Wright said. Preliminary estimates show that more than 80% of residents and 60% of staffers in more than 200 homes got a first dose by the end of December, he said.
Goode from CVS said his company’s participation in the program is being led by its long-term care division, which has deep experience with nursing homes. He noted that tens of thousands of nursing homes — about 85% nationally, according to the CDC — have found that reassuring enough to participate.
“That underscores the trust the long-term care community has in CVS and Walgreens,” he said.
Vaccine recipients don’t pay anything out-of-pocket for the shots. The costs of purchasing and administering them are covered by the federal government and health insurance, which means CVS and Walgreens stand to make a lot of money: Medicare is reimbursing $16.94 for the first shot and $28.39 for the second.
Technically, federal law doesn’t require nursing homes to obtain written consent for vaccinations.
But CVS and Walgreens require them to get verbal or written consent from residents or family members, which must be documented on forms supplied by the pharmacies.
Goode said consent hasn’t been an impediment so far, but many people on the ground disagree. The requirements have slowed the process as nursing homes collect paper forms and Medicare numbers from residents, said Tracy Greene Mintz, a social worker who owns Senior Care Training, which trains and deploys social workers in more than 100 facilities around California.
In some cases, social workers have mailed paper consent forms to families and waited to get them back, she said.
“The facilities are busy trying to keep residents alive,” Greene Mintz said. “If you want to get paid from Medicare, do your own paperwork,” she suggested to CVS and Walgreens.
Scheduling has also been a challenge for some nursing homes, partly because people who are actively sick with covid shouldn’t be vaccinated, the CDC advises.
“If something comes up — say, an entire building becomes covid-positive — you don’t want the pharmacists coming because nobody is going to get the vaccine,” said Taetz of Mariner Health.
Both pharmacy companies say they work with facilities to reschedule when necessary. That happened at Windsor Chico Creek Care and Rehabilitation in Chico, California, where a clinic was pushed back a day because the facility was awaiting covid test results for residents. Melissa Cabrera, who manages the facility’s infection control, described the process as streamlined and professional.
In Illinois, about 12,000 of the state’s roughly 55,000 nursing home residents had received their first dose by Sunday, mostly through the CVS/Walgreens partnership, said Matt Hartman, executive director of the Illinois Health Care Association.
While Hartman hopes the pharmacies will finish administering the first round by the end of the month, he noted that there’s a lot of “headache” around scheduling the clinics, especially when homes have outbreaks.
“Are we happy that we haven’t gotten through round one and West Virginia is done?” he asked. “Absolutely not.”
KHN correspondent Rachana Pradhan contributed to this report.
USE OUR CONTENT
This story can be republished for free (details).
While pharma has raced to develop COVID-19 vaccines, US-based company NeuroRx is taking a different approach to treating the virus. CEO Dr. Jonathan Javitt tells pharmaphorum about the science behind the company’s Zyesami, which targets the alveolar type II cells in the lung that are critical for transmission of oxygen.
Zyesami was developed in conjunction with partner Relief Therapeutics, and NeuroRx is currently awaiting results from a Phase 2b/3 trial (COVID-AIV) evaluating the therapeutic for the treatment of respiratory failure in COVID-19 patients.
Based on years of research by Professor Sami Said at New York’s Stony Brook University, the drug is a synthetic formulation of Vasoactive Intestinal Peptide (VIP), a naturally occurring peptide that is highly concentrated in the lungs. VIP is known to have potent anti-inflammatory effects and can inhibit coronavirus replication and block the formation of inflammatory cytokines.
“Every air-breathing warm-blooded animal makes this peptide to protect the lungs from the toxic effects of breathing air,” NeuroRx CEO, Jonathan Javitt, MD, MPH, told pharmaphorum. “It protects the lungs against all injuries and turns out it has some extraordinarily valuable properties for patients with COVID-19.”
‘A fish out of water’
When SARS-CoV-2 invades the body, it attacks the alveolar type II (ATII) cell in the lining of the lung which shuts down the production of surfactant and stimulates a cytokine response.
“This is how you go from somebody who is infected by the virus but not particularly sick to somebody who’s on a ventilator dying of COVID-19,” explained Dr. Javitt.
“For example – when a fish swims through water, seawater goes across its gills and oxygen is then absorbed from the seawater. The fish derives enough oxygen from that to carry out all the functions it needs to live. However, the minute you put that fish on the land, the fish dies. But why? There is more oxygen in the air than there is in the sea, so why would the fish die?”
The problem, he says, is due to the fact the atmosphere is toxic to the fish’s epithelial cells.
“In humans it is the same. The mixture of gases that we breathe all the time are toxic if it touches the lung’s cell, so the lung is covered by this layer of fluid that creates a barrier between the atmosphere, the air, and the cell membrane.”
The minute the ATII cells die due to the SARS-CoV-2 virus, the lung is no longer capable of oxygenation and the patient dies as well.
“It is like a fish out of water.”
Zyesami works by binding to receptors on ATII cells in the lung and protecting the surrounding pulmonary epithelium by blocking cytokines, preventing apoptosis, and upregulating the production of surfactant.
By targeting the vulnerable ATII, NeuroRx and Relief Therapeutics believe they can help the most critically ill COVID-19 patients. “Until we focus on the specific lesion associated with this virus, we’re not going to have any real cures,” concluded Dr. Javitt.
While other COVID-19 therapeutics, such as Gilead’s Veklury (remdesivir) have focused on controlling the cytokine storm triggered by COVID-19, Dr. Javitt believes this is only one piece of the puzzle.
“The cytokine storm story became popular, but it was mostly popularised by companies who already had drugs against cytokines. They created the story and then threw their monoclonal antibodies against COVID-19 but there is real scepticism now about whether COVID-19 is really a cytokine storm problem.
“Personally, I don’t think it is. I think cytokine storms are a secondary problem and until we really face the lesion that occurs when the SARS-CoV-2 virus infects the lungs and causes COVID-19, we’re not going to have a solution.”
The next steps
Top line data from Zyesami’s Phase 2b/3 trial is expected by the end of January/beginning of February and if successful, the drug could quickly receive emergency use authorisation from the FDA.
The multicenter, randomised trial was initially conducted at a single centre and expanded to 196 patients at 12 study sites. Patients were administered with escalating doses of Zyesami by intravenous infusion and compared to a placebo control group.
Early data from trials were encouraging, with results from a study at Houston Methodist hospital in Texas showing approximately 81% of the patients who received the drug survived beyond 60 days, compared to just 17% of control patients. Those who had the treatment also demonstrated a nine-fold increased probability of survival and recovery from respiratory failure.
“These patients included in our study are those who were too sick to be admitted to any other clinical trial,” said Dr. Javitt. “There were extremely ill patients who had had lung transplants, severe lung disease, heart disease, renal failure and kidney transplants so the results we have seen bring a lot of hope for how we can treat COVID-19 in future.”
Although the arrival of COVID-19 vaccines is providing hope for people, there is still a need for effective treatments. “We hope that the vaccine will reduce the number of COVID-19 cases. However, we believe it likely that population wide vaccination will be slow in coming and the vaccine is not 100% effective,” said Dr. Javitt.
NeuroRx is also gearing up for a phase of rapid expansion after closing a deal in December to combine with investment firm Big Rock Partners. The merger created a company with an estimated post-transaction equity value of more than $500 million.
The deal is expected to complete in the first quarter of 2021 and will increase NeuroRx’s access to capital for Zyesami and spur development of its other drug pipeline targeting treatment of bipolar depression.
The company is also looking at advancing trials for Zyesami in other countries around the world, with a Phase 2b/3 trial set to begin in Europe.
“One thing about our drug compared to all of these monoclonal antibodies is we can make it at enormous scale relatively inexpensively and it’s within the cost range that works for the rest of the world,” said Dr. Javitt.
About the interviewee
Dr. Jonathan Javitt is founder, chairman and CEO of NeuroRx. He is a physician with a background in information technology, health economics, and public health. His scientific publications have been cited by more than 17,000 people and he is ranked among the top 1% of quoted scientists worldwide.
The post A new approach to COVID-19 treatment appeared first on .
- Click here to hear Barry-Jester on WABE
- Read Barry-Jester’s “Pandemic Backlash Jeopardizes Public Health Powers, Leaders“
KHN Colorado correspondent Rae Ellen Bichell dissected how covid-19 exacerbates tensions between counties in Colorado on NPR’s “Weekend Edition” on Jan. 9.
- Click here to hear Bichell on NPR
- Read Bichell’s “Live Free or Die if You Must, Say Colorado Urbanites — But Not in My Hospital“
KHN chief Washington correspondent Julie Rovner talked about mental health care and the pandemic on WAMU/NPR’s “1A” on Jan. 11.
USE OUR CONTENT
This story can be republished for free (details).
Use Our Content
It can be republished for free.
Dr. Monte Junker, an Oregon dentist, is waiting for his turn to get vaccinated for covid even though he considers himself a front-line health worker.
“If they offered it to me today, I would be there,” he said.
In December, just before the first vaccines were cleared for emergency use, the Centers for Disease Control and Prevention immunization advisory board recommended that health care workers — as well as nursing home residents and staff members — be the first to be inoculated because of their high risks of infection.
But Oregon is one of a handful of states, including Colorado, North Carolina and Texas, that have put dentists lower in priority order than other health professionals who treat patients — even though they have their hands in people’s mouths and are exposed to aerosols that spray germs in their faces during procedures.
As a result, dentists in those states must wait while many of their peers got their shots in December.
Dr. Tam Le, president of the Connecticut State Dental Association, was vaccinated in December along with employees at his practice in Cheshire. He said he lobbied the state to include dentists with other front-line hospital and health workers.
“In Connecticut, we are doing really well,” he said, noting that the state set up an online registration system for eligible health workers and then contacted them about when and where they could get the vaccine. Le said he and his staff went to a nearby community health center for their shots.
Dentists gained goodwill from state officials last spring by donating gloves and masks to hospitals, Le said. They also offered to help administer the shots since they have experience with that.
States are increasingly diverging from CDC guidance in their vaccination plans, according to an analysis by KFF. “Timelines vary significantly across states, regardless of priority group, resulting in a vaccine rollout labyrinth across the country,” the report said. (KHN is an editorially independent program of KFF.)
The American Dental Association said it’s aware that the lack of a national immunization strategy has meant that dentists and their staffs are not being treated equally across the country.
The CDC advisory board included dentists when it recommended that front-line health workers get priority.
“Each state government’s approach to vaccination will be different based on populations and need, but all dental team members should be prioritized in the first-tier distribution as the vaccines roll out by the different state and county public health departments,” said Daniel Klemmedson, the ADA president. An oral surgeon in Arizona, he has been vaccinated.
In Florida, dentists and their staffs are included among front-line workers eligible for vaccines in the first wave, but a lack of supply has hindered some from getting their shots, according to Drew Eason, CEO of the Florida Dental Association. Some county health departments have also incorrectly turned dentists away, he added.
Dr. Cindy Roark, a Boca Raton dentist and chief clinical officer of Sage Dental, which has 15 offices in Florida and Georgia, said she has no idea when she’ll get vaccinated. She said Georgia dentists in her company have been vaccinated, while those in Florida must wait. The only exceptions appear to be the relatively few dentists affiliated with hospitals. “We are equally vulnerable,” she said.
Still, Roark said she is not upset. “I know I can protect myself,” she said, adding that her office staffers wear N95 masks, face shields and gloves to protect themselves and patients. “Most dentists feel completely safe running their practice and preventing transmission.”
Junker, regional dental director at Advantage Dental in The Dalles, Oregon, said he understands that intensive care staff members, emergency department workers and the elderly in nursing homes need the vaccine first.
“But we are definitely up there for the copious quantities of aerosol in our faces each day,” he said. “The atmosphere is highly concentrated” with virus.
He’s upset at the poor planning and coordination between states and the federal government to make dentists a priority.
In cases where hospital staffers are declining the vaccine because they don’t trust it, Junker said, hospitals should offer shots to dentists and others who are eager for them.
“I don’t think it’s fair for them to sit on the vaccine for a month or two. It needs to get used, and if the hospital workers later decide to get vaccinated, they can get back in line,” he said.
Dr. Stan Hardesty, a Raleigh, North Carolina, dentist and president of the state dental society, said it’s disappointing to see dentists in other states get the vaccine while he and his colleagues have been told to wait.
“We have been advocating on behalf of our members to have dentists and our team members included in phase 1a as recommended by the CDC,” he said. “Unfortunately, the decision-makers [in the state government] have decided to utilize a different prioritization in their vaccine implementation.”
North Carolina dentists will be in “phase 1b,” which includes adults 75 and older, essential workers such as police officers and firefighters.
USE OUR CONTENT
This story can be republished for free (details).
Yet South said she’s in no rush to throw away her face mask.
“I honestly don’t think I’ll ever go without a mask at work again,” said South, faculty director of the Urban Health Lab at the University of Pennsylvania in Philadelphia. “I don’t think I’ll ever feel safe doing that.”
And although covid vaccines are highly effective, South plans to continue wearing her mask outside the hospital as well.
Health experts say there are good reasons to follow her example.
“Masks and social distancing will need to continue into the foreseeable future — until we have some level of herd immunity,” said Dr. Preeti Malani, chief health officer at the University of Michigan. “Masks and distancing are here to stay.”
Malani and other health experts explained five reasons Americans should hold on to their masks:
1. No vaccine is 100% effective.
Large clinical trials found that two doses of the Moderna and Pfizer-BioNTech vaccines prevented 95% of illnesses caused by the coronavirus. While those results are impressive, 1 in 20 people are left unprotected, said Dr. Tom Frieden, a former director of the Centers for Disease Control and Prevention.
Malani notes that vaccines were tested in controlled clinical trials at top medical centers, under optimal conditions.
In the real world, vaccines are usually slightly less effective. Scientists use specific terms to describe the phenomenon. They refer to the protection offered by vaccines in clinical trials as “efficacy,” while the actual immunity seen in a vaccinated population is “effectiveness.”
The effectiveness of covid vaccines could be affected by the way they’re handled, Malani said. The genetic material used in mRNA vaccines — made with messenger RNA from the coronavirus — is so fragile that it has to be carefully stored and transported.
Any variation from the CDC’s strict guidance could influence how well vaccines work, Malani said.
2. Vaccines don’t provide immediate protection.
No vaccine is effective right away, Malani said. It takes about two weeks for the immune system to make the antibodies that block viral infections.
Covid vaccines will take a little longer than other inoculations, such as the flu shot, because both the Moderna and Pfizer products require two doses. The Pfizer shots are given three weeks apart; the Moderna shots, four weeks apart.
In other words, full protection won’t arrive until five or six weeks after the first shot. So, a person vaccinated on New Year’s Day won’t be fully protected until Valentine’s Day.
3. Covid vaccines may not prevent you from spreading the virus.
Vaccines can provide two levels of protection. The measles vaccine prevents viruses from causing infection, so vaccinated people don’t spread the infection or develop symptoms.
Most other vaccines — including flu shots — prevent people from becoming sick but not from becoming infected or passing the virus to others, said Dr. Paul Offit, who advises the National Institutes of Health and Food and Drug Administration on covid vaccines.
While covid vaccines clearly prevent illness, researchers need more time to figure out whether they prevent transmission, too, said Phoenix-based epidemiologist Saskia Popescu, an assistant professor in the biodefense program at George Mason University’s Schar School of Policy and Government.
“We don’t yet know if the vaccine protects against infection, or only against illness,” said Frieden, now CEO of Resolve to Save Lives, a global public health initiative. “In other words, a vaccinated person might still be able to spread the virus, even if they don’t feel sick.”
Until researchers can answer that question, Frieden said, wearing masks is the safest way for vaccinated people to protect those around them.
4. Masks protect people with compromised immune systems.
People with cancer are at particular risk from covid. Studies show they’re more likely than others to become infected and die from the virus, but may not be protected by vaccines, said Dr. Gary Lyman, a professor at Fred Hutchinson Cancer Research Center.
Cancer patients are vulnerable in multiple ways. People with lung cancer are less able to fight off pneumonia, while those undergoing chemotherapy or radiation treatment have weakened immune systems. Leukemia and lymphoma attack immune cells directly, which makes it harder for patients to fight off the virus.
Doctors don’t know much about how people with cancer will respond to vaccines, because they were excluded from randomized trials, Lyman said. Only a handful of study participants were diagnosed with cancer after enrolling. Among those people, covid vaccines protected only 76%.
Although the vaccines appear safe, “prior studies with other vaccines raise concerns that immunosuppressed patients, including cancer patients, may not mount as great an immune response as healthy patients,” Lyman said. “For now, we should assume that patients with cancer may not experience the 95% efficacy.”
Some people aren’t able to be vaccinated.
While most people with allergies can receive covid vaccines safely, the CDC advises those who have had severe allergic reactions to vaccine ingredients, including polyethylene glycol, to avoid vaccination. The agency also warns people who have had dangerous allergic reactions to a first vaccine dose to skip the second.
Lyman encourages people to continue wearing masks to protect those with cancer and others who won’t be fully protected.
5. Masks protect against any strain of the coronavirus, in spite of genetic mutations.
So far, studies suggest vaccines will still work against these new strains.
One thing is clear: Public health measures — such as avoiding crowds, physical distancing and masks — reduce the risk of contracting all strains of the coronavirus, as well as other respiratory diseases, Frieden said. For example, the number of flu cases worldwide has been dramatically lower since countries began asking citizens to stay home and wear masks.
“Masks will remain effective,” Malani said. “But careful and consistent use will be essential.”
The best hope for ending the pandemic isn’t to choose between masks, physical distancing and vaccines, Offit said, but to combine them. “The three approaches work best as a team,” he said.
USE OUR CONTENT
This story can be republished for free (details).
On Sundays, Bishop Bruce Davis preached love. Through his Pentecostal ministry, he organized youth parades and gave computers, bicycles and food to families in need.
During the week, Bruce practiced what he preached, caring for prisoners at a Georgia hospital. On March 27 he began coughing, and on April 1 he was hospitalized. He’d tested positive for covid-19. The virus swept through his household, infecting his wife and daughter and hospitalizing their disabled son. Ten days after landing in the hospital, Bruce died.
But when Gwendolyn Davis received her husband’s death certificate, she was taken aback. The causes of death? Sepsis and renal failure. No mention of covid-19.
“He wouldn’t have had kidney failure if he didn’t have covid,” Gwendolyn said.
After Bruce died, his wife applied to two pandemic relief programs seeking help with $1,500 in missed payments on a truck and an electricity bill. But, she said, she was denied because his death certificate didn’t mention covid-19.
“I think it’s wrong,” Gwendolyn said. “It’s almost like we didn’t count.”
The count has profound implications for families and the country. Omitting covid-19 on death certificates threatens to undercount the toll of the pandemic nationwide. For Davis’ family and others, it can pile financial hardship onto emotional despair, as death benefits and other covid-19 relief programs are withheld. Interviews with families across the U.S. shed light on reasons covid deaths are being undercounted — and the consequences loved ones have endured.
When covid patients die, the “immediate” cause of death is always something else, such as respiratory failure or cardiac arrest. Residents, doctors, medical examiners and coroners make the call on whether covid was an underlying factor, or “contributory cause.” If so, the diagnosis should be included on the death certificate, according to the Centers for Disease Control and Prevention.
Even beyond the pandemic, there is wide variation in how certifiers describe causes of death: “There’s just no such thing as an objective measure of cause of death,” said Lee Anne Flagg, a statistician at the CDC’s National Center for Health Statistics.
Partly because of a lack of training in how to fill them out, “the quality of the death certificates is not good,” said Dr. James Gill, vice president of the National Association of Medical Examiners. And in cases in which people had other chronic conditions, it can be difficult to determine whether covid was a contributing cause of death, he said. That was especially true early on, when reliable testing was not widely available.
Since early in the pandemic, the CDC has encouraged certifiers who suspect covid as a cause of death to list it on the death certificate as “probable” or “likely.”
Still, some clinicians are “reluctant to certify a death as a covid death without a test in hand,” Gill said.
It’s not clear how Bruce Davis’ case slipped under the radar. His death was certified by William Ken Garland, deputy coroner in Baldwin County. Reached by phone, Garland said the causes of death were provided by Dr. Joseph Coppiano, a medical resident who pronounced Davis dead at Augusta University Medical Center, about 90 miles away. No autopsy was done.
“I did certify the record, but that’s about all I did,” Garland said.
Hospital spokesperson Danielle Harris declined to comment on the case, citing patient privacy. She said the hospital follows Georgia Department of Public Health guidelines.
In the absence of certainty, the CDC has encouraged coroners to document the virus. “We’re not worried that we’re overcounting the number of [covid-19] deaths,” Farida Ahmad, epidemiologist and mortality surveillance team leader at NCHS, said in April.
Missed cases are one reason that experts agree covid deaths are being undercounted nationwide. As evidence for that, they point to the vast number of excess deaths — additional deaths compared to what would be expected based on prior-year numbers and demographic trends.
Over the past year, the U.S. had endured up to 431,792 excess deaths as of Jan. 6, with 68% directly attributed to covid, according to the CDC.
These excess deaths “tend to track pretty closely with covid cases, trailing by a couple of weeks,” said Daniel Weinberger, an epidemiologist at Yale School of Public Health who has published on this topic. “This strongly suggests that a large proportion of these uncounted deaths are due to covid but not recorded as such.”
We may never know how many covid deaths went uncounted: Postmortem tests can detect the virus, but it’s “unlikely that this type of testing will be performed at a [sufficient] scale,” Weinberger said. Early in the pandemic, especially in the Northeast, many of those who were treated clinically for covid and then died were not tested for the virus — so they never made it into the statistics.
Testing Troubles Affect Lawsuits, Hospital Bills
Inaccurate death certificates can make it harder to pursue a lawsuit or win a workers’ compensation case when a loved one dies after contracting covid on the job. Gwendolyn Davis did win workers’ compensation death benefits from Bruce’s employer, a state psychiatric facility in Milledgeville, by providing medical records. But problems with covid testing can complicate the process.
Bruce’s supervisor at work, Mark DeLong, also died after contracting covid, but it did not appear on his death certificate with the other causes: cardiopulmonary arrest, respiratory failure and diabetes.
The omission on DeLong’s certificate seemed to stem from a delay in test results: His covid-positive results didn’t arrive until three days after he died, according to his widow, Jan DeLong. She has asked the local coroner to correct the record.
In New Jersey, attorney Paul da Costa represents 75 family members who lost loved ones at veterans homes in Menlo Park and Paramus in April and May. He said he knows of at least five patients whose death certificates did not list covid-19 despite evidence suggesting it killed them.
The root problem, he said, was a “complete dearth of testing.” Patients were transferred to hospitals, or dying in the veterans facilities, without ever being tested, he said.
The gap between excess deaths and confirmed covid deaths has “narrowed over time as testing has increased,” Weinberger said.
Early testing inaccuracy may also have led to undercounting, which creates a different burden: hospital bills. Without a diagnosis, families can be on the hook for thousands of dollars in charges that otherwise would have been covered under the CARES Act.
Correcting the Record
In some cases, families have sought to have death certificates changed to reflect covid. Dorothy Payton, 95, who lived in the ManorCare nursing home in Denver, first showed covid symptoms April 5. Five days later, Payton — known as “Nana Dee” — tested positive for it. And on April 13, her husband, Edward Benjamin, received a call that she had died.
The death certificate offered a litany of causes: vascular dementia, atrial fibrillation, congestive heart failure, gait instability, difficulty swallowing and “failure to thrive.”
But not covid-19. So it “seemed logical to fight for listing her cause of death under her cause of death,” Benjamin said.
After a few calls, her husband was able to get the certificate amended. ManorCare could not be reached for comment.
For Benjamin, it wasn’t about public health statistics or financial considerations. It simply offers a sense of closure.
“I want her life and death remembered the way it was, and I’m glad we set the record straight,” he said. “It’s the first step towards moving on.”
This story is part of “Lost on the Frontline,” an ongoing project from The Guardian and Kaiser Health News that aims to document the lives of health care workers in the U.S. who die from COVID-19, and to investigate why so many are victims of the disease. If you have a colleague or loved one we should include, please share their story.
USE OUR CONTENT
This story can be republished for free (details).
South Korea’s Celltrion has announced encouraging top-line results for its potential antibody therapy for COVID-19, with the first part of a phase 2/3 trial showing it could cut recovery times and chances of progression from moderate to more severe disease.
Several other companies are also working on antibody therapies and Eli Lilly’s bamlanivimab gained an FDA Emergency Use Authorization in November last year, shortly after Regeneron’s cocktail of casirivimab and imdevimab.
There are doubts over efficacy of Lilly’s antibody, which failed to produce benefits in hospitalised patients in a phase 3 trial last month.
AstraZeneca is developing an antibody therapy and so is its UK rival GlaxoSmithKline, which this week announced a deal with VIR Biotechnology to trial VIR-7832 in mild to moderate COVID-19 patients.
Until COVID-19 hit Celltrion was best known for producing biosimilars, which are near-copies of biologic drugs that have been shown to be as safe and effective in rigorous trials and tests.
But the company is using its expertise to develop an antibody therapy, CT-P59, to help the effort against the pandemic.
Celltrion filed the therapy with the Korean regulator at the end of December and plans to submit data to regulators in Europe and the US in the coming months.
A spokesperson said in an email that company is “working closely with the regulatory agencies to accelerate the regulatory procedures”.
Part I of the trial enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three treatment groups (40mg/kg, 80mg/kg and placebo), in which approximately 60% of patients with moderate symptoms suffered from COVID-19 related pneumonia.
This data analysis has demonstrated that at day 28, CT-P59 treated patients presented with a significantly reduced risk of COVID-19 related hospitalisation and oxygenation without mortality.
When compared to placebo, CT-P59 treated patients reported reduced progression rates to severe COVID-19 by 54% for mild-to-moderate patients and 68% for moderate patients aged 50 years and over.
CT-P59 treatment groups also reported with significantly shortened time to clinical recovery ranging from 3.4 to 6.4 days quicker compared to placebo.
Patients treated with CT-P59 recovered 3.4 days earlier than those in a placebo group, while patients with pneumonia reported that their recovery time was 5.1 days shorter compared with placebo.
A group of patients with moderate disease aged 50 years and over treated with CR-P59 reported that their recovery time was 6.4 days shorter than placebo, the company said.
CT-P59 treated patients rapidly and significantly reduced viral load through Day 7 compared to placebo. Top-line results from the trial shows CT-P59 to have a positive safety profile, comparable to that of the placebo group, with no serious adverse advents reported.
Infusion related reactions were mild and transient, with the CT-P59 treatment group having reported 0.5%, compared to 1.8% reported with placebo.
Feature image courtesy of Rocky Mountain Laboratories/NIH
The post Celltrion closes in on COVID-19 antibody market after trial success appeared first on .
Can’t see the audio player? Click here to listen on SoundCloud.
The reverberations from the Jan. 6 storming of the U.S. Capitol by supporters of President Donald Trump continue. A broad array of business groups, including many from the health industry, are halting contributions to Republicans in the House and Senate who voted against certifying the victory of President-elect Joe Biden. Meanwhile, Republicans in the House who have refused to wear masks or insisted on carrying weapons are being subjected to greater enforcement, including significant fines.
Away from the Capitol, the Trump administration has granted a first-in-the-nation waiver to Tennessee to turn its Medicaid program into a block grant, which would give the state potentially less federal money but more flexibility to structure the federal-state health program for those with low incomes. And in its waning days, the administration is moving to make its last-minute policies harder for Biden to undo.
This week’s panelists are Julie Rovner of KHN, Joanne Kenen of Politico, Margot Sanger-Katz of The New York Times and Kimberly Leonard of Business Insider.
Among the takeaways from this week’s podcast:
- The decision by industry groups to cut their political contributions to some Republican lawmakers could reshape businesses’ relationships on Capitol Hill. But it’s still not clear if this announcement will affect the vast sums of political contributions that come through PACs and other unnamed sources, as well as individual contributions from corporate officials.
- The slow start of the covid vaccination campaign points to the tension between the need to steer the vaccine to people at high risk of contracting the disease and the concerns about wasting the precious medicine. Because the vaccines that have been approved for emergency use have a relatively short shelf life, some doses may go to waste if they are reserved for specific populations.
- The response to the vaccine among health care workers varies widely. In some areas, staffers are eager to get the shots, while in other places, some workers have been hesitant and the shots are going unused. And the federal government has not provided a strong public messaging campaign about the vaccines.
- The Trump administration’s announcement last week that it would move to convert Tennessee’s Medicaid program to a block grant program is raising concerns among advocates for the poor, who fear that the flexibility the state is gaining could lead to enrollees getting less care, especially since the state will get a hefty portion of any savings it finds in running the program.
- It may not be easy for the Biden administration to change this decision. Federal officials in recent weeks have been sending states, including Tennessee, letters to sign that could protect the Medicaid waivers they have received from the Trump administration and could serve as a legal guarantee that would require a long, difficult process to unwind.
- Mental health care may be a casualty of the coronavirus pandemic. As states look to balance their budgets after a year in which revenues were slashed, they may turn to cutting mental health care services provided through Medicaid and other programs.
Also this week, Rovner interviews KHN’s Victoria Knight, who wrote the latest KHN-NPR “Bill of the Month” feature — about an unusually large bill for in-network care. If you have an outrageous medical bill you’d like to share with us, you can do that here.
Plus, for extra credit, the panelists recommend their favorite health policy stories of the week that they think you should read too:
Julie Rovner: The Washington Post’s “Young ER doctors Risk Their Lives on the Pandemic’s Front Line. But They Struggle to Find Jobs,” by Ben Guarino
Margot Sanger-Katz: The New York Times’ “Why You’re Probably Not So Great at Risk Assessment,” by AC Shilton
Joanne Kenen: The Atlantic’s “Why Aren’t We Wearing Better Masks?” by Zeynep Tufekci and Jeremy Howard
Kimberly Leonard: Business Insider’s “I Was Offered a Covid Vaccine Even Though I’m Young and Healthy. Here’s How I Did It,” by Kimberly Leonard
To hear all our podcasts, click here.
USE OUR CONTENT
This story can be republished for free (details).
Finally, the End is Near!!!
I am not talking about THE end of the world but an end to our struggles with the deadly COVID-19 pandemic.
Because, the COVID-19 Vaccine is on its way to us (And I mean literally, it is on the way as we are talking).
According to an NDTV post on 12 January 2021, the first batch of the Covishield vaccine, a version of the Oxford-AstraZeneca’s vaccine that is being manufactured by the Serum Institute of India, has left for Delhi and 12 other cities of the country.
And all of this preparation is for the
World biggest inoculation drive, India’s Covid-19 vaccination drive, which is to be held on 16 January 2021, as Tweeted by the Hon’ble Prime Minister himself.
I know that you all must have hundreds of questions regarding the vaccine and are really curious about this drive.
And must be wondering what the vaccines that are going to be used are? How will it be given to people? And who will receive the vaccine first and what’s the process?
But, Don’t worry!!!
All of these questions along with the others will be covered in this blog.
Read more to find everything about the Vaccines for COVID-19:
What are the Vaccines that are going to be used in the COVID-19 Vaccination Drive?
You all must have known that in the last year 2020, the whole research facilities and manufacturing companies around the world were trying to create the Vaccine.
And after numerous attempts, they have succeeded.
Because now, there are a broad range of COVID-19 vaccines candidates that are being investigated globally using various technologies and platforms.
Some of them are in the clinical trials, others are at initial stages. But, there are a few that have passed the final clinical trial stage and are ready to enter the market.
On the 16 January Vaccination drive, these 2 vaccines will be used:
Developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV), Covaxin is India’s indigenous COVID-19 vaccine.
Covaxin uses inactivated’ or ‘dead’ coronavirus, which triggers an immune response when entered the body.
So, if faced with a similar virus in future, then the body will fight it back.
Manufactured by Serum Institute of India, Covishield is a version of the Oxford-AstraZeneca’s vaccine.
And when the vaccine is injected into the human body, a spike protein of SARS-CoV-2 coronavirus is inserted into ChAd0x virus.
So, as soon as the human body cell recognizes the spike protein, it triggers an immunological reaction against the virus.
These vaccines will be given in two doses that will be 28 days apart. And both the doses have to be taken in order to complete the vaccination schedule.
The vaccine will be given at fixed venues that will be medical centres, hospitals, along with schools and community halls.
Who will be given the Vaccine first?
The Vaccination process of the COVID-19 vaccine is divided into 2 phases, the first and second phase.
First Phase of the Vaccination Drive:
In the first phase of the vaccination, around 3 crore healthcare and frontline workers, from both the private and government sectors, will be vaccinated using the 2 vaccines.
The frontline workers include police and paramilitary personnel, sanitation workers, home guards, and disaster management volunteers.
Also receiving the vaccination in the first phase will be civil defence and revenue officials associated with containment and surveillance.
Hon’ble Prime Minister Narendra Modi has assured that 3 crore healthcare and frontline workers will receive the COVID-19 vaccine free of cost and that the state governments will not have to bear the financial burden of it.
Second Phase of the Vaccination Drive:
Then the second phase of the vaccination drive will cover nearly 27 crore people, making it the world’s largest COVID-19 inoculation drive.
People above 60 and those between 50 and 60 years of age groups with co-morbidities will be given the vaccine in the second phase.
After the completion of the priority vaccination, the rest of the population will be vaccinated in a staggered manner.
What will be the Vaccination Process?
People who are eligible for the first phase of the vaccination will be informed through their registered mobile number.
The information about the health facility where the vaccine will be provided and the health schedule will be sent to them.
On the appointed date, people who are registered will be given the vaccine.
To check for any adverse effects, vaccinated individuals will be kept under observation by a five-member vaccination team, for 30 minutes.
Two weeks after the second dose, protective levels of the antibodies against the virus will develop.
It is important to ensure that both doses of the vaccination should be completed with a single type of vaccine, as different Covid-19 vaccines are not interchangeable.
Will the Vaccine interferes with the medication for cancer, diabetes, and hypertension, etc.?
The medication will not affect vaccine efficacy.
People with one or more co-morbid conditions are at a higher risk of getting infected. Therefore, they should take the vaccine.
Also, people who have recovered from the COVID-19 infection should also take the complete schedule of the vaccine, as it helps develop a better immune response against the disease.
Hope this vaccination drive becomes a successful event and the vaccine works efficiently in combating the deadly coronavirus.
If you guys find this blog helpful and informative to you then, like and share it with others.
Feel free to share your suggestions with us by writing in the comment section.
Stay Safe, Stay Healthy…
Previous COVID-19 infection provides some immunity for at least five months, but people may still carry and transmit the virus, according to a study by Public Health England.
A first report from PHE’s SIREN study found antibodies from previous COVID-19 infection provide 83% protection against reinfection for at least five months.
It found that reinfections in people with antibodies were rare, with only 44 potential reinfections among 6,614 participants who showed evidence of previous infection.
But a small number of people with antibodies may still be able to carry and transmit COVID-19 according to the study.
As a result, PHE stressed the importance of following “stay at home” rules currently in place in the UK to prevent the virus from spreading.
Public Health England has been regularly testing tens of thousands of health care workers across the UK since June for new COVID-19 infections as well as the presence of antibodies, which suggest people have been infected before.
SIREN study leaders are clear this first report provides no evidence towards the antibody or other immune responses from COVID-19 vaccines, nor should any conclusions be drawn on their effectiveness. The SIREN study will consider vaccine responses later this year.
Professor Susan Hopkins, senior medical advisor at Public Health England and the SIREN study lead said: “This study has given us the clearest picture to date of the nature of antibody protection against COVID-19 but it is critical people do not misunderstand these early findings.
“We now know that most of those who have had the virus, and developed antibodies, are protected from reinfection, but this is not total and we do not yet know how long protection lasts. Crucially, we believe people may still be able to pass the virus on.”
The news comes as the UK continues to endure high levels of infections despite a national lockdown.
There have been more than 74,000 deaths following coronavirus infections and nearly 43,000 new cases were recorded in the last day.
Last year the government announced that PHE is to be scrapped and merged with the NHS test and trace programme and the UK’s Joint Biosecurity Centre.
The post Study says COVID-19 infection provides immunity, but people can transmit virus appeared first on .
UK biotech Synairgen is pushing ahead with a phase 3 trial of SNG001 in hospitalised COVID-19 patients, after encouraging topline results from a phase 2 study that started last March.
The inhaled formulation of interferon beta-1a – delivered using a nebuliser – will be tested in 610 hospitalised COVID-19 patients who require supplemental oxygen in around 20 countries in the study, called SG018.
Interferon beta-1a is already used in an injectable form for multiple sclerosis, and before the pandemic took hold Synairgen was already putting its inhaled version through its paces in trials involving subjects with asthma and chronic obstructive pulmonary disease (COPD).
The cytokine is part of the body’s response to a viral infection, and there is some evidence to suggest that people who get dangerously sick after being infected with the SARS-CoV-2 virus have lower than usual levels of interferon beta in the lungs.
The Southampton-based company says it has appointed contract research organisation (CRO) Parexel to help conduct the phase 3 trial, with several UK sites now set up and others in the US and the EU expected to follow soon.
The first patient received the treatment at Hull Royal Infirmary this week, and Synairgen is hoping to get results available in the summer, which means emergency approvals could be feasible by the autumn.
Preliminary results from Synairgen’s 100-patient phase 2 trial SG016 were published in The Lancet last November, and found that patients treated with SNG001 had greater odds of improvement and recovered more rapidly from SARS-CoV-2 infection than patients who received placebo.
The main endpoint in the trial was Ordinal Scale for Clinical Improvement (OSCI) – a standard nine-point measure developed by the World Health Organization (WHO).
Patients taking SNG001 were more likely to show an improvement on the OSCI scale on day 15 or 16 after dosing started, and were more likely than those receiving placebo to recover to an OSCI score of 1 – with no limitation of their daily activities – during treatment.
There were also three deaths in the placebo group and none among patients taking SNG001, although the trial wasn’t statistically powerful enough to gauge whether that was a real effect or due to chance.
The UK’s National Institute for Health Research (NIHR) has given the phase 3 trial Urgent Public Health status, so it qualifies for support by the NIHR’s clinical research network. Meanwhile, the FDA has awarded fast-track status to SNG001 for COVID-19.
While the vaccine roll-out is raising spirits in the midst of the pandemic, Synairgen chief executive Richard Marsden said treatments are still needed for “cases where vaccines are not effective, for those who do not get vaccinated, and in case the virus mutates to the point where vaccines become less effective.”
“We believe this trial presents an opportunity for a significant UK scientific breakthrough and, if given the right support, our drug could rapidly assist with the global crisis,” he added.
Synairgen told the BBC that a course of treatment with SNG001 would cost around £2,000, which according to Marsden will represent “good value for money”.
The post Synairgen starts dosing inhaled COVID-19 drug in phase 3 trial appeared first on .
- The P-II/III study involves assessing of CT-P59 (40mg/kg, 80mg/kg) vs PBO in 327 patients with mild-to-mod. symptoms of COVID-19
- Results: reduction in progression rates (54% for mild-to-mod. patients & 68% for mod. patients aged ≥50yrs.); recovery days (5.4 vs 8.8 days); recovery time in patients with pneumonia & patients aged ≥50yrs. (5.7 vs 10.8 & 6.6 vs 13days) respectively. CT-P59 showed reduction in viral load @day7 with SAEs reported
- The preclinical data demonstrated a 100-fold reduction in viral load of SARS-CoV-2 and improved recovery time in animal models, that has been published in Nature Communications journal
Click here to read full press release/ article | Ref: Businesswire | Image: Medicircle
The post Celltrion Report Results of CT-P59 in P-II/III Study for COVID-19 first appeared on PharmaShots.
I’d seen coverage of some final covid messages during this terrible year. They were usually directed to spouses, but my No. 1 concern was how to explain my own death to my 3-year-old, Marigold, whom we call “Goldie.” How much of me would she remember, and how would she make peace with what happened to me, when I could barely believe it myself?
After the emergency room doctor confirmed pneumonia in both of my lungs on Dec. 17, I was whisked upstairs to the hospital’s covid unit, where I got a blood thinner injection, infusions of steroids and remdesivir, and continued on the supplemental oxygen they had started in the ER.
Immediately after the treatments, my mind was clearer and more focused than it had been in the nine days since my husband, daughter and I had all received positive covid results (and when my raging fevers began). As I lay in my hospital bed, my roommate’s TV blaring, I started thinking about my daughter’s understanding of death. A lapsed evangelical married to a Jewish man, I had adopted his family’s perspective on the afterlife — that discussing it wasn’t very important — but had also inadvertently abdicated the death discussion to Hollywood.
Goldie’s afterlife education began with the movie “Coco,” about the Mexican Day of the Dead, in which families put pictures of their ancestors on a home altar, or ofrenda. Then came “Over the Moon,” in 2020, about a little girl in China who loses her mom to illness and struggles to accept a new stepmother, all while her mom’s spirit visits her in the form of a crane.
That prompted her first question about my death.
“Are you going to die like Fei Fei’s mom did?” Goldie asked me in November, before I got sick. I told her at the time that no one knows when they’re going to die, but that I would love her with all of my heart for as long as I lived.
After that, Goldie would sometimes randomly declare, “I don’t think you’re going to die,” or she would ask if we could all die together, at the same time — to which I’d say, “Sure!”
My covid symptoms started Dec. 7, and we got our positive results back the next morning. Thankfully, my husband and daughter had almost no symptoms except stuffy noses and a day of low fever. But I started off with a fever that would burn me up to 104 degrees, over and over again. Tylenol and Advil could bring it down only to 100 or 101. I would cry as the painful fevers reached their peak and wondered if God had been preparing Goldie all along this year for my eventual death.
My breathing problems began eight days later. The scariest moment during that time was when I was in the middle of a shower (much needed after days of sweaty fevers) and realized I was gasping for air. I punched the shower curtains out of my way and ran to my bed, where I could lie on my stomach and get my oxygen levels up again. As I lay there, hyperventilating, soaking wet, with shampoo still in my hair, the pulse oximeter monitor registered 67, before inching back up to 92. I began thinking of what I wanted to say to Goldie in my final letter to her, but I was too weak to type it out.
Two more uterine procedures led to a successful embryo transfer, but a miscarriage put me in the ER on Oct. 8. By then, Los Angeles County had seen 278,665 cases and 6,726 deaths — horrifying numbers that I monitored and reported on as a health journalist, but data points I couldn’t, or wouldn’t, use to alter the decision-making in my own life.
With four miscarriages now under my belt and no more viable embryos left to use, my husband, Simon, and I decided we’d give in vitro fertilization one final try. I started my injections for an egg retrieval in late November, and by the time the procedure rolled around on Dec. 3, L.A. was well into its scary, almost vertical holiday season ascent, posting 7,854 new cases that day — up fivefold from a month earlier.
A close friend was supposed to start her IVF injections at the same time, but she decided to postpone at the last minute because covid cases were so high in our area. By that point, we were so driven in our pursuing of pregnancy that I was startled to hear her say that, as the thought had never even crossed my mind.
I have no way of knowing for sure if I was exposed to the virus sometime during this last fertility treatment. The surgical center is located on a large medical campus that also hosts a covid-19 testing drive-thru in the garage where we parked. We waited, masks on, for almost an hour outside the building, which we thought was a safer choice than the fertility clinic waiting room, but that actually put us in proximity to a lot of sick people waiting for rides home.
I also had to remove my mask just before the actual egg retrieval, because I was under anesthesia and the doctors needed quick access to my mouth in case I needed a breathing tube.
Five days after the egg retrieval, we found out we were covid-positive. I called the clinic right away to warn them; the fertility doctor told me a few days later that none of her staffers had gotten sick. And also that none of the eggs they retrieved from me had developed properly. We had no embryos to use.
Of course, as anyone who has done fertility treatments knows, all the dangers and risks we undertook would have been “worth it” if it had worked. Because it didn’t work for us, I felt defeated and foolish.
In sum, we wanted to give Goldie a sibling, but attempting to do so may have been what threatened her mother’s life. This thought haunts me and will stay with me forever, even though I’ll never know how exactly the virus entered our home.
Our nanny, who also experienced covid symptoms and tested positive three days before us, could have picked it up at the supermarket. We could have gotten it from her or while walking around our neighborhood or playing in the park. But the act of choosing, over and over again, to engage in fertility treatments as the pandemic raged on, fills me with doubt and remorse.
This was all too much to put in my goodbye letter to Goldie. Instead, this is some of what I wrote:
Around Halloween, you and I were eating breakfast together and I asked you how your life was going, and if there were any improvements I could make for you. You said, with absolute seriousness, “I’m afraid of ghosts.”
Now that I’m a ghost, I hope there’s less reason to be afraid.
Please put my picture on the ofrenda once a year. I’ll always be in your heart and in your memories. I will try to visit you too. But not in a spooky way, just a gentle way.
I will always love you. Thank you so much for being born to us. You made everything better.
After finishing my goodbye letter, I went to sleep. In the morning, I woke up, got a second infusion of steroids and remdesivir, and then was released home with oxygen tanks and an oxygen concentrator. I stayed in bed, on oxygen, for another week before my lungs were strong enough for me to stand and walk on my own. We had a wonderful Christmas morning together opening presents during a Zoom call with my family. Other than fatigue, I am now almost back to normal.
After the holidays, I sat down with Goldie for breakfast as we usually do. Feeling morose about how the year had turned out, I asked, dreading her response, if she would like to have a baby brother or sister one day.
She put her hand on my neck and pressed her forehead into mine, a face-to-face embrace that we call a “pumpkin hug.”
“No, Mom,” she said. “I want it to be just you and me, forever.”
I took a deep breath, and then sighed with relief.
USE OUR CONTENT
This story can be republished for free (details).
The vaccines themselves are delicate and require a fair bit of focus over time. Consider Moderna’s instructions for preparing its doses: Select the number of shots that will be given. Thaw the vials for 2.5 hours in a refrigerator set between 36 and 46 degrees. Then rest them at room temperature for 15 minutes. Do not refreeze. Swirl gently between each withdrawal. Do not shake. Inspect each vial for particulate matter or discoloration. Store any unused vaccine in refrigeration.
And then there’s this: Once open, a vial is good for only six hours. As vaccines go, that’s not very long. Some flu vaccine keeps almost a month.
“This is very different, administering this vaccine. The process, it takes a whole lot longer than any mass vaccination event that I’ve been involved with,” said Suri, a member of the Loudoun Medical Reserve Corps who joined her first clinic Dec. 28, to vaccinate first responders.
Of the first two covid vaccines on the market, Moderna’s is considered more user-friendly. Pfizer-BioNTech’s shot must be stored in specialized freezers at 94 degrees below zero. Once out of deep freeze, it lasts just five days, compared with 30 days for Moderna’s.
One thing the shots have in common: They last a paltry six hours once the first dose is removed from a vial. That short shelf life raises the stakes for the largest vaccination effort in U.S. history by forcing clinicians to anticipate the exact number of doses they’ll need each day. If they don’t get it right, precious stores of vaccine may go to waste.
During one recent clinic over several hours, Suri estimated she gave “maybe 25” shots, many fewer than the number of flu shots she’s given during similar clinics over the years.
With covid, she said, “the vaccine itself slows things down.”
The slow rollout has frustrated people who at Thanksgiving imagined millions of vaccines in arms by Christmas. Promises that 20 million would be vaccinated by New Year’s fell well short: Just 2.8 million had the first of two required shots by the end of December, according to data from the Centers for Disease Control and Prevention.
Public health officials say many factors are at play, including a shortage of workers trained to administer shots, covid protocols that require physical distancing at clinics and vaccine allocation numbers from the federal government that fluctuate by the week.
And then there are the logistics of the first covid vaccines, which are complex and make hyper-vigilant practitioners wary of opening too many vials over the course of each day, for fear that anything unused will have to be tossed. Vaccine providers also report wasted or spoiled doses to public health authorities.
“If you get to the end of your clinic and every nurse has half a vial left, what are you going to do with that vaccine?” Suri said. “The clock is ticking. You don’t want to waste those doses.”
That impulse has led some health personnel to make dramatic decisions at the end of a day: calling non-front-line health workers or offering shots to whoever is at hand in, say, a grocery store, instead of scrambling to find the health workers and residents of nursing homes in the government’s first tier for injections.
“We jumped and ran and got the vaccine,” said Dr. Mark Hathaway, an OB-GYN in the District of Columbia who received the first dose of a Moderna vaccine on Dec. 26 along with his wife, a registered nurse specializing in nutrition. Both clinicians received vaccines faster than anticipated at a Unity Health Care clinic when there were extra doses because fewer front-line health care workers than expected showed up.
“Health care workers have been priority 1a, so our first attempt has always been our staff,” said Dr. Jessica Boyd, Unity Health Care’s chief medical officer. Since then, the community health center network has broadened its criteria for extra doses to include staff members or high-risk patients visiting a clinic, she said.
Health officials encourage using the doses to get as many Americans vaccinated as quickly as possible. Public health experts say the need to vaccinate people is especially urgent as a new and more contagious variant of the virus first detected in the United Kingdom is showing up in multiple states. Some states, including New York and California, have loosened their guidelines on who can get vaccinated after an outcry over health care providers throwing away doses that didn’t meet officials’ strict criteria.
The tiers “are simply recommendations, and they should never stand in the way of getting shots in arms instead of keeping vaccine in the freezer or wasting vaccine in the vial,” Health and Human Services Secretary Alex Azar said Jan. 6, referring to CDC guidelines saying health care workers and residents and staff of long-term care facilities should be first in line, then people at least 75 years old. The Trump administration this week also said it would make more shots available by releasing second doses and urged states to broaden rules to allow anyone 65 or older and any resident with a serious medical condition to get a shot.
Pfizer-BioNTech’s ultra-cold storage requirements have made it less ideal for local public health departments and rural areas.
Both of the available vaccines arrive in multidose vials — Pfizer-BioNTech’s contains about five doses, Moderna’s 10. Neither contains preservatives and they are viable for only six months frozen. By contrast, during the H1N1 pandemic roughly a decade ago, the swine flu vaccines lasted 18 weeks to 18 months, Sen. Chuck Grassley (R-Iowa) wrote in a May 2010 letter to then-HHS Secretary Kathleen Sebelius.
“We can’t get the vaccine out fast enough; we have people dying. But, at the same time, we have to get it right,” said Claire Hannan, executive director of the Association of Immunization Managers.
The added risk of losing doses due to quick expiration is another thing “causing angst,” Hannan said. “You can’t just draw it up and let it sit. It can’t just sit out like that.”
The Trump administration fell significantly short of its promise that 20 million Americans would be vaccinated by the end of December, partly the result of a disjointed and underfunded public health system that has received limited guidance from federal officials. As of Jan. 11, 25.5 million vaccine doses had been distributed nationwide but only 9 million administered, according to the CDC.
Federal officials have released sparse data about who is getting vaccinated, but state information has shown significant variation in vaccination rates depending on the facility. New York Gov. Andrew Cuomo on Jan. 4 said New York City’s public hospital system had used only 31% of its allocated vaccines, while private health systems NewYork-Presbyterian and Northwell Health had used 99% and 62%, respectively.
“When you target a priority group, it’s inefficient. When you open it up to a larger group, it’s efficient … but you’re not going to have enough supply,” Hannan said. “You still have the challenge of getting those health care workers vaccinated and no matter any way you slice it, you still have limited supply. You can’t please everyone.”
While Pfizer’s vaccine has largely been earmarked for large institutions like hospitals and nursing homes, Moderna’s has been more widely distributed to smaller sites like public health departments and clinics run by volunteers. State and local officials have begun or will soon vaccinate other priority populations, including police officers, teachers and other K-12 school employees, and seniors overall.
Unlike the covid vaccines, many flu vaccines come in prefilled syringes — each syringe’s cap is removed only when a shot is given, which speeds the process and eases some concerns about storage. However, relying on prefilled syringes during a pandemic has its own complications, according to Michael Watson, former president of Valera, a Moderna subsidiary: They take up more fridge space. They’re more expensive. And they can’t be used for frozen products, he said.
“For all these reasons, a vial was the best and only option,” he said.
In Ohio, Eric Zgodzinski, health commissioner for Toledo-Lucas County, said two-thirds of first responders the county surveyed said they would get the vaccine. Still, he said, his department has encountered situations in which a covid vaccine dose is left over in an open vial and officials have turned to a waiting list to find someone who can arrive within minutes to get a jab.
His department also has an internal running list of potential vaccine takers, including health department staffers, people in congregate care settings or those who had scheduled vaccination appointments for later on.
“We’re not going to open up a vial for one individual and figure out nine other people right away,” said Zgodzinski, whose department planned to distribute 2,200 doses of the Moderna vaccine the week of Jan. 4.
“If I have one dose left, who can I give it to?” he added. “A shot in the arm for anybody is better than it being wasted.”
San Francisco editor Arthur Allen and senior correspondent JoNel Aleccia contributed to this report.
USE OUR CONTENT
This story can be republished for free (details).
USE OUR CONTENT
It can be republished for free.
In these first lumbering weeks of the largest vaccination campaign in U.S. history, Dr. Julie Vaishampayan has had a battlefront view of a daunting logistical operation.
Vaishampayan is the health officer in Stanislaus County, an almond-growing mecca in California’s Central Valley that has recorded about 40,000 cases of covid-19 and lost 700 people to the illness. Her charge is to see that potentially lifesaving covid shots make it into the arms of 550,000 residents.
And like her dozens of counterparts across the state, she is improvising as she goes.
From week to week, Vaishampayan has no idea how many new doses of covid vaccines will be delivered until just days before they arrive, complicating advance planning for mass inoculation clinics. The inoculation clinics themselves can be a bureaucratic slog, as county staffers verify the identities and occupations of people coming in for shots to ensure strict compliance with the state’s multitiered hierarchy of eligibility. In these early days, the county also has provided vaccines to some area hospitals so they can inoculate health care workers, but the state system for tracking whether and how those doses are administered has proven clumsy.
With relatively little help from the federal government, each state has built its own vaccination rollout plan. In California, where public health is largely a county-level operation, the same departments managing testing and contact tracing for an out-of-control epidemic are leading the effort. That puts an already beleaguered workforce at the helm of yet another time-consuming undertaking. A lack of resources and limited planning by the federal and state governments have made it that much harder to get operations up and running.
“We are flying the plane as we are building it,” said Jason Hoppin, a spokesperson for Santa Cruz County. ”All of these logistical pieces are just a huge puzzle to work out.”
It’s a massive enterprise. Counties must figure out who falls where in the state’s multitiered system for eligibility, locate vaccination sites, hire vaccinators, notify workforce groups when they are eligible, schedule appointments, verify identities, then track distribution and immunizations administered.
Some of that burden has been eased by a federal program that is contracting with major pharmacies Walgreens and CVS to vaccinate people living in nursing homes and long-term care facilities, as well as a California mechanism that allows some large multicounty health care providers to order vaccines directly. As of this week, some smaller clinics and doctors’ offices also can get vaccine directly from the state.
But much of the job falls on health departments, the only entities required by law to protect the health of every Californian. And they are doing it amid pressures from the state to prevent people from skipping the line and a public eager to know why the rollout isn’t happening faster.
As of Monday, only a third of the nearly 2.5 million doses allocated to California counties and health systems had been administered, according to the most recent state data available. Gov. Gavin Newsom has acknowledged the rollout has “gone too slowly.” Health directors counter it’s the best that could be expected given the short planning timeline, limited vaccine available and other strictures.
“I would not call this rollout slow,” said Kat DeBurgh, executive director of the Health Officers Association of California. “This isn’t the same as a flu vaccine clinic where all you have to do is roll up your sleeve and someone gives you a shot.”
It has been one month since the first vaccines arrived in California, and just over five weeks since the state first outlined priority groups for vaccinations, then passed the ball to counties to devise ways to execute the plan.
Like most states, California opened its rollout with strict rules about the order of distribution. The first phase prioritized nursing home residents and hospital staffs before expanding to other broad categories of health care workers. In the weeks after the vaccines first arrived, state officials made clear that providers could be penalized if they gave vaccinations to people not in those initial priority groups.
Multiple counties said there had been little in the way of line-skipping, but stray reports in the media or complaints sent directly to community officials need to be chased down, wasting precious public health resources. The same goes for reports of vaccine doses being thrown away. One of the vaccines in circulation, once removed from ultra-cold storage, must be used within five days or discarded.
State officials have since loosened their rules, telling counties and providers to do their best to adhere to the tiers, but not to waste doses. On Jan. 7, California officials told counties they could vaccinate anyone in “phase 1a,” expanding beyond the first priority group of nursing homes and hospitals to nearly everyone in a health-related job. Once that wide-ranging category is finished, counties were supposed to move to “phase 1b,” which unfolds with its own set of tiers, starting with people 75 and older, educators, child care workers, providers of emergency services, and food and agricultural workers before expanding to all people 65 and older.
Mariposa and San Francisco both said they would be vaccinating people in the first 1b categories this week. That means residents will start seeing inequities among counties, said DeBurgh, noting that some counties had not yet received enough vaccine doses to cover health care workers while others are nearly finished. Stanislaus County, for example, had received approximately 16,000 first doses as of Jan. 9, but estimates it has between 35,000 and 40,000 health care workers phase 1a.
And the orders are changing yet again, forcing counties to pivot. On Tuesday, U.S. Health and Human Services Secretary Alex Azar said the Trump administration would begin releasing more of its vaccine supply, holding onto fewer vials for second doses; and he encouraged states to open up vaccinations to everyone age 65 and older. In response, California officials said Wednesday that once counties are done with phase 1a, people 65 and older are in the next group eligible for vaccines.
Some local health directors expressed dismay at the prospect, saying they welcome the influx of vaccines but need to prioritize people 75 and older who represent the bulk of hospitalizations. They also noted that states already offering broader access have had their own challenges, including flooded health department phone lines, crashed websites and fragile seniors camping out overnight in hopes of securing their place in line.
While sensible in theory, California’s phased approach to the rollout has proved cumbersome when it comes to verifying that people showing up for shots fall under the umbrella groups deemed eligible. In Stanislaus, for example, 6,600 people qualify as in-home support workers. Someone from another county department has to sit with health department staffers to verify their eligibility, since the health department doesn’t have access to official data on who is a qualified member of the group.
Complicating matters, about half the county’s in-home workers are caring for a family member, and many are bringing that person with them to get vaccinated. The county is required to turn those family members away if they don’t meet the eligibility criteria, Vaishampayan said.
A range of other hiccups hampered the rollout. Across the state, uptake of vaccination slowed to a crawl from Christmas to New Year’s. Health workers, particularly those who do not work in hospitals, were on vacation and enjoying a few days off with family after a tough year, several county officials said. Many chose not to get vaccinated during that time.
Others are choosing not to get vaccinated at all. Across the state, health care workers are declining vaccinations in large numbers. The health officer for Riverside County has said 50% of hospital workers there have declined the vaccine.
And in Los Angeles and Sonoma, officials described software challenges that prevented them from quickly enrolling doctors’ offices to receive vaccines and perform injections.
Still, statewide, officials said they were confident that the pace would pick up in the coming days, as more doses arrive, data snags get sorted out and more vaccination sites come on board. Los Angeles County announced this week it would convert Dodger Stadium and a Veterans Affairs site from mass testing sites into mass vaccination clinics. Similar plans are underway at Petco Park in San Diego and the Disneyland Resort in Orange County. Officials hope Dodger Stadium alone can handle up to 12,000 people a day.
The move solves one problem, but potentially exacerbates another: The two Los Angeles sites have been testing 87,000 people a week, according to Dr. Christina Ghaly, Los Angeles County Department of Health Services director. That will put new constraints on testing, even as covid cases in the nation’s most populous county continue to rise and hospitals are beyond capacity.
USE OUR CONTENT
This story can be republished for free (details).
Use Our Content
It can be republished for free.
For weeks, doctors’ phones have been ringing off the hook with anxious older patients on the other end of the line.
“When can I get a covid-19 vaccine?” these patients want to know. “And where?”
Frustration and confusion are rampant as states and counties begin to offer vaccines to all seniors after giving them first to front-line health care workers and nursing home residents — the groups initially given priority by state and federal authorities.
My 91-year-old mother-in-law, who lives in upstate New York, was one of those callers. She said her doctor’s office told her it could be several months before she can get her first shot.
That was before New York’s Gov. Andrew Cuomo announced on Friday that the state would begin offering vaccines to residents age 75 and older starting Monday. On Tuesday, the state changed vaccine policies again, this time making residents 65 and older eligible.
In this chaotic environment, with covid cases and deaths skyrocketing and distribution systems in a state of disarray, it’s difficult to get up-to-date, reliable information. Many older adults don’t know where to turn for help.
Since the holidays, I’ve heard from dozens of people frustrated by poorly informed staffers at physicians’ offices, difficult-to-navigate state and county websites, and burdensome or malfunctioning sign-up arrangements. Below are some questions they posed, with answers drawn from interviews with experts and other sources, that may prove helpful.
Keep in mind that states, counties and cities have varying policies, and this is a rapidly shifting landscape with many uncertainties. Foremost among them are questions regarding vaccine supply: how many doses will become available to states and when and how those will be allocated.
Q: How can I make an appointment to get a vaccine? — James Vanderhye, 77, Denver
Vanderhye is a throat cancer survivor who suffers from sarcoidosis of the lungs and heart — an inflammatory disease.
Colorado Gov. Jared Polis announced on Dec. 30 that residents 70 and older could start getting covid vaccines, but Vanderhye wasn’t sure whether he needed to sign up somewhere or whether he’d be contacted by his physicians — a common source of confusion.
UCHealth, the system where Vanderhye’s doctors practice, has created a registry of patients 70 and older and is randomly selecting them for appointments, Dr. Jean Kutner, its chief medical officer told me. It’s reaching out to patients through its electronic patient portal and is planning to notify those who don’t respond by phone down the line. Then, it’s up to patients to finalize arrangements.
Nearly 200,000 people 70 and older are patients at UCHealth’s hospitals and clinics in Colorado, Wyoming and Nebraska.
TIPS: Although some health systems such as UCHealth are contacting patients, don’t assume that will happen. In most cases, it appears, you will need to take the initiative.
Check with the physician’s office, hospital or medical clinic where you usually receive care. Many institutions (though not all) are posting information about covid vaccines on their websites. Some have set up phone lines.
Some health systems are willing to vaccinate anyone who signs up, not just their patients. Kaiser Permanente, which operates in California, Colorado, Georgia, Hawaii, Oregon, Washington, Washington, D.C., and parts of Virginia and Maryland, is among them, according to Dr. Craig Robbins, co-leader of its national covid vaccination program. (Within the next few weeks, it will post an online registration tool on plan websites.) Check with major hospitals or health systems in your area to see what they’re doing. (KHN is not affiliated with Kaiser Permanente.)
Most places are asking people to sign up online for appointments; some sites require multiple steps and their systems may seem hard to use. If you don’t have a computer or you aren’t comfortable using one, ask a younger family member, friend or neighbor for help. Similarly, ask for help if you aren’t fluent in English.
If you can’t figure out how to sign up online, call your local county health department, Area Agency on Aging or county department on aging and ask for assistance. Every state has a covid-19 hotline; see if the hotline can direct you to a call center that’s taking appointments. Be prepared for long waits; phone lines are jammed.
Q: My mother has stage 3 renal failure, high blood pressure and dementia. She’s unable to take care of herself or be left alone. When can I get her vaccinated with the COVID shot? — Wendy, 61, Chandler, Arizona
Wendy had checked Maricopa County’s website days before we talked on Jan. 5 and couldn’t figure out when her 84-year-old mother might get a vaccine appointment. The week before, her 90-year-old father died, alone, of renal failure complicated by pneumonia in a nursing home.
Three days after our conversation, Maricopa County announced that people 75 and older could start making appointments to be vaccinated on a “first-come, first-served” basis on Monday, Jan. 11. (The state’s appointment site is https://podvaccine.azdhs.gov/; callers should try 844-542-8201 or 211, according to information provided by the county.)
In Arizona, “it’s up to each county to come up and execute a plan for vaccine distribution,” said Dana Kennedy, state director of AARP Arizona.
Demand is high and vaccine supplies are limited, other places have found. For example, on Jan. 7, a 1,200-slot vaccine clinic in Oklahoma City for adults 65 and older filled up within four minutes, according to Molly Fleming, a public information officer at the Oklahoma City-County Health Department.
“Once we get more vaccine supplies coming more frequently, we will do more clinics,” Fleming said. “The challenge we have right now is, we need the vaccine and we don’t know when it’s coming in.”
TIPS: Consult AARP’s state-by-state covid vaccine guides, focused on older adults and updated daily. (To access, go to https://www.aarp.org/coronavirus/. In the right-hand column, click on “the vaccine in your state.”) More than 20 states are listed there now, but guides for all states should be available by the end of January.
Meanwhile, check local media and your county’s and state’s health department websites regularly for fresh information about covid vaccine distribution plans.
On Monday, for example, Washington, D.C., unveiled a new vaccination registration site for residents 65 and older and health care workers. The week before, Illinois announced it would extend vaccines to residents 65 and older when it moved into the next phase of its vaccination plan, and the city of Chicago followed suit. The timetable for those transitions remains unclear.
Be prepared to be patient as problems with distribution surface. States and counties around the country are learning from problems that have arisen in places such as Florida — crashed phone lines, long lines of older adults waiting outdoors, massive confusion. It may take some time, but vaccine rollouts should become smoother as more sites come online and supplies become more readily available.
Q: When can a 72-year-old male with chronic lymphocytic leukemia expect to be vaccinated at Kaiser Permanente in Southern California? — Barry
California last week announced that counties that have made significant progress and have adequate supplies can move toward offering vaccines to residents 75 and older.
How soon this will happen isn’t clear yet; it will vary by location. But even then, Barry wouldn’t qualify immediately since he’s only 72 and it could take several months for vaccines to become available to people in his age group (65 to 74), said Robbins, who’s helping lead Kaiser Permanente’s vaccination program.
Barry is at especially high risk of doing poorly if he develops covid because of the type of cancer he has — leukemia. But, for the most part, medical conditions are not being taken into account in the initial stages of vaccine distribution around the country.
An exception is the Mayo Clinic. It’s identifying patients at highest risk of getting severe infections, being hospitalized and dying from covid at the Mayo Clinic Health System, a network of physician practices, clinics and hospitals in Iowa, Minnesota and Wisconsin. When states allow older adults outside of long-term care institutions to start getting vaccines, it will offer them first to patients at highest risk, said Dr. Abinash Virk, co-chair for Mayo Clinic’s vaccine rollout.
TIPS: Even if vaccines aren’t available right away, production is increasing, new products are in the pipeline, and new ways of distributing vaccines — notably mass distribution sites — are being planned. If you have to wait several weeks or months, don’t give up. Persistence is worth the effort, given the vaccine’s benefits.
USE OUR CONTENT
This story can be republished for free (details).
The acute phase of the COVID-19 pandemic tested the UK’s capacity and capability to rapidly deliver crucial clinical research at a time of immense pressure and stress on personnel and resources.
It triggered a system-wide response which took the UK’s collaborative culture to new levels. This multi-agency approach enabled unprecedented speed and efficiency in trial approvals, set-up and recruitment. By eliminating delays and duplication, and optimising all available resources throughout our NHS, the UK was able to answer questions of global importance about COVID-19, including treatment and management.
Having successfully demonstrated our ability to coordinate, expedite and accelerate research delivery there is now an opportunity to reflect on what the UK did well and what this means for the future.
This pharmaphorum webinar, held in association with the National Institute for Health Research (NIHR), will take place on Thursday 25th February 13:00 GMT / 14:00 CET and discuss the UK’s approach to delivering research during the COVID-19 pandemic. It will examine lessons learnt from implementing complex design trials on a national scale and question what the UK could have done differently.
The webinar will also cover:
- How research was prioritised
- Processes for streamlining approvals
- Learnings on site selection and set-up
- Strategies for successful and rapid recruitment
View the webinar* by clicking on the link in the window above or by clicking here.
Dr Kirsty Wydenbach is an expert medical assessor and the deputy unit manager in the Clinical Trials Unit at MHRA, having joined in 2009. She has been involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including ATMPs and numerous first-in-human studies. She has also been involved in European discussions aiming to establish an EU harmonised approach to clinical trials, particularly for Developmental Safety Update Reports (DSURs) and Reference Safety Information (RSI). She was also an EMA expert for the update of the First-in-Human guideline. Other recent work has included collaboration with external industry groups and regulators regarding adaptive and novel trial designs: she is leading on this aspect for the MHRA in order to implement that aspect of the Life Sciences Industrial Strategy and was a contributor to the EU CTFG Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials. More recently Kirsty has overseen the clinical trial work for COVID-19 and provided regulatory expertise on vaccines both within MHRA but also as part of the government Vaccine Taskforce.
Sir Terence Stephenson is an eminent clinical academic and took up the position of chair at the Health Research Agency on 1 September 2019. He is Nuffield Professor of Child Health at the University College London Great Ormond Street Institute of Child Health and Honorary Consultant Paediatrician at UCL Hospitals NHS Foundation Trust & Great Ormond Street Hospital for Children NHS Foundation Trust. Sir Terence is also a former Dean of the University of Nottingham’s Medical School, President of the Royal College of Paediatrics and Child Health, Chair of the Academy of Medical Royal Colleges, and most recently of the General Medical Council.
Professor Nick Lemoine is medical director of the National Institute for Health Research Clinical Research Network for England. Nick has recently been appointed chair of the COVID-19 urgent public health studies group for the UK. The group’s remit is to consider all clinical studies relating to COVID-19 and to fast-track those with the greatest promise. Nick also chairs the NIHR Invention for Innovation Challenge Panel. Nick is director of the Barts Cancer Institute, Queen Mary University of London, and director of research & development for Cancer at Barts Health NHS Trust, the largest NHS Trust in the country. Among other commitments, he is the chair of Trustees of the Medical Research Foundation (the MRC’s independent charity), and executive dean of the Academy of Medical Sciences, Zhengzhou University, People’s Republic of China. He was elected as a Fellow of the Academy of Medical Sciences in 2006, and as a Foreign Academician of the Chinese Academy of Engineers in 2017.
Dominic Tyer, interim managing editor, pharmaphorum [moderator] Dominic Tyer is a trained journalist and editor with 19 years of pharmaceutical and healthcare publishing experience. He serves as interim managing editor at pharmaphorum media, which facilitates productive engagement for pharma, bringing healthcare together to drive medical innovation. He is also creative and editorial director at the company’s specialist healthcare content consultancy, pharmaphorum connect.
The post Coordinating and delivering research in the pandemic: The UK approach appeared first on .
- Roche confirms that the US govt. will purchase additional supply of Regeneron’s Ab cocktail for use in non-hospitalized COVID-19 patients as part of Operation Warp Speed
- The agreement additional supply of Regeneron’s Ab cocktail for use in non-hospitalized COVID-19 patients as part of Operation Warp Speed.
- The cocktail has received the US FDA’s EUA for recently diagnosed, high-risk, mild to moderate COVID-19 patients. Roche & Regeneron collaborated to develop and manufacture casirivimab and imdevimab under which Regeneron is distributing it in the US while Roche will be responsible for distribution outside the US
Click here to read full press release/ article | Ref: Roche | Image: Bloomberg
Trial sites have adapted swiftly to the restrictions of COVID-19, and patients have seen many knock-on benefits as a result. The next step is ensuring the industry does not regress to old ways of working once the pandemic is over, say Karen McIntyre and Allyson Small.
COVID-19 has changed everything for clinical trials – but in most cases these are changes that were well overdue.
“For years and years, the industry has debated the practicalities and safety of decentralising clinical trials, using telemedicine, and where study activities should take place,” says Karen McIntyre, executive director, global lead Catalyst Program & site relationships at Syneos Health. “We were always having these discussions, but nothing moved forward.”
When the pandemic hit, regulators around the world rapidly updated their guidelines to reflect the realities of conducting trials amidst lockdowns and social distancing mandates.
“For example, drugs are now able to be delivered directly to patients to allow for a clinical trial visit to take place remotely,” says McIntyre.
• Read the full article in pharmaphorum’s Deep Dive digital magazine
The post ‘No going back’ for clinical trials after COVID appeared first on .
Hackers posted stolen confidential information about Pfizer/BioNTech’s COVID-19 vaccine online, the European Medicines Agency has said in an update.
The EMA last month revealed that documents relating to the Pfizer/BioNTech vaccine were stolen in a cyber-attack on its records.
Since then the agency has been investigating the incident involving the theft of documents that formed part of BioNTech’s filing for the BNT-162b vaccine.
In its latest statement, the EMA said that the investigation “revealed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines belonging to third parties have been leaked on the internet.”
The EMA added that “necessary action is being taken by the law enforcement authorities.”
It gave no further details about where the documents were posted, adding that further information will be provided “in due course” as the investigation continues.
The EMA said its regulatory framework remains fully functional and timelines relating to review and approval of COVID-19 medicines and vaccines are not affected.
Just days before the EMA hack emerged in mid-December, analysts from IBM warned that a phishing campaign had targeted organisations involved with the cold chain needed to keep vaccine supplies moving.
The operation began in September and spanned six countries and looked like the work of an unnamed “nation-state”, the analysts said in a blog post.
While individual cyber criminals would be unlikely to profit from the information they argued that “advanced insight into the purchase and movement of a vaccine that can impact life and the global economy is likely a high-value and high-priority nation-state target.”
Sam Curry, chief security officer at Cybereason, said that the actions were “diabolical” but added that bringing the perpetrators to justice would be “more fantasy than reality.”
Curry added that hackers see COVID-19 data as a “valuable asset” and will continue to do so for the “foreseeable future.”
He added: “Kudos to the pharma and research companies for working with law enforcement agencies to face these threats head on with advanced cyber tools and improved security hygiene.
The hackers “are well funded and are looking to reap both financial and political fame,” Curry added.
“As the protection surface expands to mobile, the cloud and other potential attack vectors, those companies that can detect a breach quickly and understand as much as possible about the hacking operation itself, will be able to stop the threat and minimise or eliminate the risk all together.”
Feature image copyright BioNTech SE 2020, all rights reserved
The post Hackers posted stolen COVID-19 vaccine info online, says EU regulator appeared first on .
But he’s not sure he’ll get a chance to use it, given health officials have so far not said when private doctor’s offices will get vaccine.
“I’m really angry,” said Carroll.
Not only are doctors having trouble getting vaccine for patients, but many of the community-based physicians and medical staff that aren’t employed by hospitals or health systems also report mixed results in getting inoculated. Some have had their shots, yet others are still waiting, even though health workers providing direct care to patients are in the Centers for Disease Control and Prevention’s top-priority group.
Many of these doctors say they don’t know when — or if — they will get doses for their patients, which will soon become a bigger issue as states attempt to vaccinate more people.
“The reason that’s important is patients trust their doctors when it comes to the vaccine,” said Carroll, who has complained on social media that his county hasn’t yet released plans on how primary care doctors will be brought into the loop.
Collectively, physicians in the county could vaccinate thousands of patients a day, he said, and might draw some who would otherwise be hesitant if they had to go to a large hospital, a fairground or another central site.
His concern comes as, nationally, the rollout of the vaccine is off to a slower start than expected, lagging far behind the initial goal of giving 20 million doses before the new year.
But Dr. Jen Brull, a family practice doctor in Plainville, Kansas, said her rural area has made good progress on the first phase of vaccinations, crediting close working relationships formed well before the pandemic.
This fall, before any doses became available, the local hospital, the health department and physician offices coordinated a sign-up list for medical workers who wanted the vaccine. So, when their county, with a population of 5,000, got its first 70 doses, they were ready to go. Another 80 doses came a week later.
“We’ll be able to vaccinate almost all the health care-associated folks who wanted it in the county” Brull said recently
Gaps in the Rollout
But that’s not the case everywhere.
Dr. Jason Goldman, a family doctor in Coral Gables, Florida, said he was able to get vaccinated at a local hospital that received the bulk of vaccines in his county and oversaw distribution.
In the weeks since, however, he said several of his front-line staff members still “don’t have access to the vaccine.”
Additionally, “a tremendous number” of patients are calling his office because Florida has relaxed distribution guidelines to include anyone over age 65, Goldman said, asking when they can get the vaccine. He’s applied to officials about distributing the vaccines through his practice but has heard nothing back.
Patients “are frustrated that they do not have clear answers and that I am not being given clear answers to provide them,” he said. “We have no choice but to direct them to the health department and some of the hospital systems.”
Another troubling point for Goldman, who served as a liaison between the American Academy of Family Physicians and the expert panel drawing up the CDC distribution guidelines, is the tremendous variation in how those recommendations are being implemented in the states.
The CDC recommends several phases, with front-line health care workers and nursing home residents and staff in the initial group. Then, in the second part of that phase, come people over 75 and non-health care front-line workers, which could include first responders, teachers and other designated essential workers.
States have the flexibility to design their own rollout schedule and priority groups. Florida, for example, is offering doses to anyone 65 and up. In some counties, older folks were told vaccines were available on a first-come, first-served basis, a move that has resulted in long lines.
“To say right now, 65-plus, when you haven’t even appropriately vaccinated all the health care workers, is negating the phasing,” said Goldman. “There needs to be a national standard. We have those guidelines. We need to come up with some oversight.”
On Thursday, the American Hospital Association echoed that concern in a letter to Health and Human Services Secretary Alex Azar. Hospitals — along with health departments and large pharmacy chains — are doing the bulk of the vaccinations.
Calling for additional coordination by federal officials, the letter outlined what it would take to reach the goal of vaccinating 75% of Americans by the end of May: 1.8 million vaccinations every day. Noting there are 64 different rollout plans from states, cities and other jurisdictions, the letter asked whether HHS has “assessed whether these plans, taken as a whole, are capable of achieving this level of vaccination?”
Making It Work
Lack of direct national support or strategy means each county is essentially on its own, with success or failure affected by available resources and the experience of local officials. Most state and local health departments are underfunded and are under intense pressure because of the surging pandemic.
Still, the success of vaccination efforts depends on planning, preparation and clear communication.
In Lorain County, Ohio, population 310,000, local officials started practicing in October, said Mark Adams, deputy health commissioner. They set up mass vaccination clinics for influenza to study what would be needed for a covid vaccination effort. How many staff? What would the traffic flow be like? Could patients be kept 6 feet apart?
“That gave us an idea of what is good, what is bad and what needs to change,” said Adams, who has had previous experience coordinating mass vaccination efforts at a county level.
So, when the county got its first shipment of 500 doses Dec. 21, Adams had his plan ready. He called the fire chiefs to invite all emergency medical technicians and affiliated personnel to an ad hoc vaccination center set up at a large entertainment venue staffed by his health department. Upon arrival, people were greeted at the door and directed to spaced-apart “lanes” where they would get their shots, then to a monitoring area where they could wait for 15 minutes to make sure they didn’t have a reaction.
Right after Christmas, another 400 doses arrived — and the makeshift clinic opened again. This time, doses went to community-based physicians, dentists and other hands-on medical practitioners, 600 of whom had previously signed up. (Hospital workers and nursing home staff and residents are getting their vaccinations through their own institutions.)
As they move into the next phase — recipients include residents over 80, people with developmental disorders and school staff — the challenges will grow, he said. The county plans a multipronged approach to notify people when it’s their turn, including use of a website, the local media, churches, other organizations and word-of-mouth.
Adams shares the concerns of medical providers nationwide: He gets only two days’ notice of how many doses he’s going to receive and, at the current pace of 400 or 500 doses a week, it’s going to take a while before most residents in the county have a chance to get a shot, including the estimated 33,000 people 65 and older.
With 10 nurses, his clinic can inject about 1,200 people a day. But many other health professionals have volunteered to administer the shots if he gets more doses.
“If I were to run three clinics, five days a week, I could do 15,000 vaccinations a week,” Adams said. “With all the volunteers, I could do almost six clinics, or 30,000 a week.”
Still, for those in the last public group, those age 18 and up without underlying medical conditions, “it could be summer,” Adams said.
USE OUR CONTENT
This story can be republished for free (details).
Use Our Content
It can be republished for free.
Last week, after finishing inoculations of some front-line hospital staff, Jupiter Medical Center was left with 40 doses of precious covid vaccine. So, officials offered shots to the South Florida hospital’s board of directors and their spouses over age 65.
But that decision sparked outrage among workers left unvaccinated, including those at one of the hospital’s urgent care clinics, or who believe the hospital was currying favor with wealthy insiders before getting all its staffers protected, according to a hospital employee who spoke on the condition of not being named.
The move also prompted dozens of calls from donors looking to get vaccinated.
The hospital received 1,000 doses of the Moderna vaccine two days before Christmas, fewer than half of what it requested from the state to cover its workforce. Officials prioritized delivering the vaccine to front-line medical workers who requested it, performing inoculations on Christmas Eve or the holiday weekends.
Patti Patrick, a hospital vice president, said the hospital acted appropriately in its offerings of the vaccine, which has a short shelf life once vials are opened. Neither she nor other administrators who don’t work directly with patients were included in this first round of shots.
“This was a simple way to move 40 doses very quickly” before it spoiled, she said.
She added that all front-line staff from the health system, including the clinics, were given the opportunity to get the shots.
Jupiter is not the only hospital in the nation facing questions about its handling of the vaccines. The initial rollout — aimed at health care workers and nursing home residents — has been uneven at best because of a lack of a federal strategy on how it should work, with states, hospitals, nursing homes and pharmacies often making decisions on their own about who gets vaccinated and when.
In some hospitals, administrators and other personnel who have no contact with patients or face no risk at work from the virus are getting shots, while patients — and even front-line staff — who are at heightened risk for covid complications are being passed by. Some administrators who have been working remotely throughout the pandemic have been vaccinated, especially at hospitals that decided to allocate doses by age group rather than exposure risk.
Although states and federal health groups laid out broad guidelines on how to prioritize who gets the vaccine, in practice what’s mattered most was who controlled the vaccine and where the vaccine distribution was handled.
Stanford Health Care in California was forced to rework its priority list after protests from front-line doctors in training who said they had been unfairly overlooked while the vaccine was given to faculty who don’t regularly see patients. (Age was the important factor in the university’s algorithm.)
Members of Congress have called for an investigation following media reports that MorseLife Health System, a nonprofit that operates a nursing home and assisted living facility in West Palm Beach, Florida, vaccinated donors and members of a country club who donated thousands of dollars to the health company.
At least three other South Florida hospital systems — Jackson Health, Mount Sinai Medical Center and Baptist Health — have offered vaccines to donors in advance of the general public, while administering the shots to front-line employees, The Miami Herald reported.
Like Jupiter Medical, the hospitals insist that those offered shots were 65 and older, as prioritized by state officials.
Staffing Problems at Hospitals
An advisory board to the Centers for Disease Control and Prevention designated hospitals and nursing homes to get covid vaccines first because their workers and residents were considered at highest risk, and most states have followed that recommendation. But in many cases, the health institutions have found demand from staffers, some of whom are leery of the voluntary shot, is less than anticipated.
In addition, the arrival of promised shipments has been unpredictable. While the federal government approved the first covid vaccine on Dec. 14, some hospitals did not receive allotments until after Christmas.
That was the case at Hendry Regional Medical Center in Clewiston, Florida, which got 300 doses from the state. The hospital vaccinated 30 of its 285 employees between Dec. 28 and Jan. 5, said R.D. Williams, its chief executive officer. Some employees preferred to wait until after New Year’s weekend out of concern about side effects, he said.
The vaccine has been reported to commonly cause pain at the injection site and sometimes produce fever, lethargy or headache. The reactions generally last no more than a few days.
“I’m happy with how it’s going so far,” Williams said. “I know many of our employees want to be vaccinated, but I don’t see it as a panacea that they have to have it today,” he said, noting that staffers already have masks and gloves to protect themselves from the virus.
The hospital is also trying to coordinate vaccination schedules so 10 people at a time get the shot to ensure none of the medication is wasted after the multidose vials are thawed. Once vaccine is thawed, it must be used within hours to retain its effectiveness.
As of Jan. 6, Howard University Hospital in Washington, D.C., had vaccinated slightly more than 900 health workers since its first doses arrived Dec. 14. It has received 3,000 doses.
Success has been limited by reluctance among workers to get a vaccine and a lack of personnel trained to administer it, CEO Anita Jenkins said.
“We still have a hospital to run and have patients in the hospital with heart attacks and other conditions, and we don’t have additional staff to run the vaccine clinics,” she said.
While some hospitals offer the vaccine only to front-line workers who interact with patients, Howard makes it available to everyone, including public relations staff, cafeteria workers and administrators. Jenkins defended the move because, she said, it’s the best way to protect the entire hospital.
She noted such employees as information technology personnel who don’t see patients may be around doctors and nurses who do. “Working in a hospital, almost everyone runs into patients just walking down the hallway,” she said.
At Eisenhower Health, a nonprofit hospital based in Rancho Mirage, California, 2,300 of the 5,000 employees have been vaccinated.
“Our greatest challenge has been managing the current patient surge and staffing demands in our acute and critical care areas while also trying to ensure we have adequate staffing resources to operate the vaccine clinics,” said spokesperson Lee Rice.
A Non-System of Inequitable Distribution
Arthur Caplan, a bioethicist at NYU Langone Medical Center in New York City, said hospitals should not be inoculating board members ahead of hospital workers unless those people have a crucial role in running the hospital.
“That seems, to me, jostling to the head of the line and trying to reward those who may be potential donors,” he said. But he acknowledged that the hospitals’ vaccination systems are not always rational or equitable.
Covid vaccines need to get out as quickly as possible, he added, but hospitals can give them only to people they are connected with.
Caplan noted he was vaccinated at an NYU outpatient site last week, even though his primary care doctor hadn’t yet gotten the vaccine because his clinic had not received any doses.
USE OUR CONTENT
This story can be republished for free (details).
As states widen eligibility requirements for who can get a covid-19 vaccine, health officials are often taking people’s word that they qualify, thereby prioritizing efficiency over strict adherence to distribution plans.
“We are doing everything possible to vaccinate only those ‘in phase,’ but we won’t turn away someone who has scheduled their vaccine appointment and tells us that they are in phase if they do not have proof or ID,” said Bill Christian, spokesperson for the Tennessee Department of Health.
Among the states pivoting to vaccinating all seniors, timelines and strategies vary. Tennessee started offering shots to people 75 and older on Jan. 1. So, Frank Bargatze of Murfreesboro, Tennessee, snagged an appointment online for his father — and then went ahead and put his own name in, though he’s only 63.
“He’s 88,” Bargatze said, pointing to his father in the passenger seat after they both received their initial shots at a drive-thru vaccination site in Murfreesboro, a large city outside Nashville. “I jumped on his bandwagon,” he added with a laugh. “I’m going to blame it on him.”
Bargatze does work a few days a week with people in recovery from addiction, he added, so in a way, he might qualify as a health care worker.
Some departments are trying more than others, but overwhelmed public health departments don’t have time to do much vetting.
Dr. Lorraine MacDonald is the medical examiner in Rutherford County, Tennessee, where she’s been staffing the vaccination site. If people seeking the vaccine make it through the sign-up process online, MacDonald said, and show up for their appointment, health officials are not going to ask any more questions — as long as they’re on the list from the online sign-up.
“That’s a difficult one,” MacDonald acknowledged, when asked about people just under the age cutoff joining with older family members and putting themselves down for a dose, too. “It’s pretty much the honor system.”
People getting vaccinated in several Tennessee counties told a reporter they did not have to show ID or proof of qualifying employment when they arrived at a vaccination site. Tennessee’s health departments are generally erring on the side of simply giving the shot, even if the person is not a local resident or is not in the country legally.
The loose enforcement of the distribution phases extends to other parts of the country, including Los Angeles. In response, New York’s governor is considering making line-skipping a punishable offense.
Still, many people who don’t qualify on paper believe they might need the vaccine as much as those who do qualify in the initial phases.
Gayle Boyd of Murfreesboro is 74, meaning she didn’t quite make the cutoff in Tennessee, which is 75. But she’s also in remission from lung cancer, and so eager to get the vaccine and start getting back to a more normal life, that she joined her slightly older husband at the Murfreesboro vaccination site this week.
“Nobody’s really challenged me on it,” she said, noting she made sure to tell vaccination staffers about her medical issues. “Everybody’s been exceptionally nice.”
Technically, in the state’s current vaccine plan, having a respiratory risk factor like lung cancer doesn’t leapfrog anyone who doesn’t otherwise qualify. But in some neighboring states such as Georgia, where the minimum age limit is 65, Boyd would qualify.
Even for those who sympathize with such situations, anecdotes about line-skipping enrage many trying to wait their turn.
“We try to be responsible,” said 57-year-old Gina Kay Reid of Eagleville, Tennessee.
Reid was also at the Murfreesboro vaccination site, sitting in the back seat as she accompanied her older husband and her mother. She said she didn’t think about trying to join them in getting their first doses of vaccine. “If you take one and don’t necessarily need it, you’re knocking out somebody else that is in that higher-risk group.”
But there is a way for younger, healthier people to get the vaccine sooner than later — and not take a dose away from anyone more deserving.
A growing number of jurisdictions are realizing they have leftover doses at the end of every day. And the shots can’t be stored overnight once they’re thawed. So some pharmacists, such as some in Washington, D.C., are offering them to anyone nearby.
Jackson, Tennesse, has established a “rapid response” list for anyone willing to make it down to the health department within 30 minutes. Dr. Lisa Piercey, the state’s health commissioner, said her own aunt and uncle received a call at 8 p.m. and rushed to the county vaccination site to get their doses.
Piercey called it a “best practice” that she hopes other jurisdictions will adopt, offering a way for people eager for the vaccine to get it, while also helping states avoid wasting precious doses.
USE OUR CONTENT
This story can be republished for free (details).
ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio.
Approvals for injectable vaccines for COVID-19 are starting to build, but non-injectables like oral and intranasal vaccines could be required if the pandemic is to be fought across all areas of the globe, according to Wayne Channon, the UK firm’s chairman.
“Non-injectables remove the need for health professional-led immunisation programmes, making widespread vaccine roll-outs quicker and easier and more affordable,” Channon told pharmaphorum.
“They also offer the potential for self-administration at home rather than in a health setting, making compliance with booster dosage potentially higher.”
ImmunityBio’s hAd5 candidate – using iosBio’s technology – has already shown encouraging preclinical results in non-human primates using an initial injection followed by two oral booster doses.
An injectable/oral ‘prime and boost’ regimen is in a phase 1b study due to conclude in November, according to the clinicaltrials.gov database, and ImmunityBio has said it is also recruiting patients for a phase 2/3 trial.
In time, it may be possible to deliver the entire immunisation course by the oral route, according to iosBio, while ImmunityBio has suggested the oral candidate could be used to provide a boost to other injectable vaccinations.
One of the primary advantages of this approach is that the oral vaccine capsules are stable at room temperature, which means they do not require cold chain storage. They are also cheaper to produce and store and can be distributed across the globe easily – all without the need for specialised equipment or personnel – according to iosBio.
“This is particularly important in developing countries, where access to cold-chain is limited,” said Channon.
There are other theoretical advantages as well. For instance, oral vaccines could allow repeat dosing without a treatment-limiting anti-vector response – where the body generates an immune response against the harmless, non-replicating viruses used to deliver the COVID-19 antigens.
“This can render the repeat administration of that vaccine as a booster, or a vaccine against a different infectious disease using the same viral vector, ineffective,” according to Channon.
The lack of anti-vector immunity in the gastrointestinal (GI) tract means repeat dosing with vaccines based on iosBio’s tech is possible, he suggested, because of the natural level of tolerance in the gut that avoids generating an immune response to food, for instance.
“This allows the same vector to be repeatedly orally administered and re-used for multiple vaccine programmes.”
ImmunityBio – led by billionaire surgeon and Nantworks and NantKwest founder Patrick Soon-Shiong – isn’t the only company looking at non-injectable COVID-19 vaccines.
Vaxart said in November it had completed enrolment in a phase 1 trial of its oral COVID-19 vaccine VXA-CoV2-1, having reported viral load reduction and antibody responses in a COVID-19 hamster challenge model. Symvivo also has an oral candidate in a phase 1 study which started last November.
Altimmune meanwhile is taking a different tack with its single-dose intranasal candidate AdCOVID, which had been due to generate initial clinical study results in the next few weeks but was placed on a clinical hold by the FDA last month after a request for more manufacturing data.
Soon-Shiong said that oral vaccines could have another key advantage as they stimulate mucosal, systemic and T-cell immune responses.
“As we see multiple mutations in the SARS-CoV-2 spike protein, there is an urgent need for a vaccine that not only offers immediate protection but also activates T-cells to clear the virus,” he said.
ImmunityBio’s vaccine design drives both antibody and T-cells to the spike (S) protein and nucleocapsid (N) protein.
That means it could “potentially serve as a universal boost to current vaccines that focus only on the monovalent S protein, as well as address future mutations of the S protein,” according to Soon-Shiong.
ImmunityBio and NantKwest announced last month they will merge into a single company focusing on immunotherapies and cell therapies for cancer and infectious diseases.
The post Oral COVID-19 vaccine beckons, as ImmunityBio licenses iosBio tech appeared first on .
- The companies signed an agreement with to evaluate VIR-7832 vs PBO in P-Ib/IIa AGILE study in patients with mild to mod. COVID-19. The trial is expected to be initiated in Q1’21 across up to five sites in the UK
- The preclinical data demonstrated that VIR-7832 enhanced ability to clear infected cells and enhance virus-specific T cell function, treating or prevent COVID-19 infection
- VIR-7832 is a dual-action mAb, currently being evaluated in two global P-III studies for the early treatment of COVID-19 in patients who are at high risk of hospitalization, and for hospitalized patients with COVID-19
Click here to read full press release/ article | Ref: GSK | Image: Medical Dialogues
The post GSK and VIR Biotechnology to Evaluate VIR-7832 in the Early Treatment of COVID-19 first appeared on PharmaShots.
USE OUR CONTENT
It can be republished for free.
SACRAMENTO, Calif. — The coronavirus pandemic doomed Gov. Gavin Newsom’s ambitious plans last year to combat homelessness, expand behavioral health services and create a state agency to control soaring health care costs.
But even as the pandemic continues to rage, California’s Democratic governor said Friday he plans to push forward with those goals in the coming year, due to a rosier budget forecast buoyed by higher tax revenue from wealthy Californians who have fared relatively well during the crisis.
Newsom’s $227.2 billion budget blueprint also prioritizes billions to safely reopen K-12 schools shuttered by the pandemic, $600 payments for nearly 4 million low-income Californians — in addition to federal stimulus payments — and coronavirus relief grants and tax credits for hard-hit small businesses.
However, his 2021-22 fiscal year spending plan does not include additional public health money for local health departments steering California’s pandemic response, which have been chronically underfunded. He vowed to support cities and counties by boosting state testing and contact tracing capacity, speeding vaccination efforts and funding state-run surge hospitals that take overflow patients.
Newsom said Friday his budget reflects a “pandemic-induced reality” with investments aimed at spurring California’s economic recovery by helping businesses and people living in poverty. Wealth and income disparities, he added, “must be addressed.”
But Democrats in control of the state legislature, county leaders and social justice groups say that will be difficult to achieve because Newsom’s spending plan does not sufficiently fund health and social safety-net programs.
And without additional public health money, local leaders worry California will not be able to adequately control the spread of the virus.
“County public health is drowning,” said Graham Knaus, executive director of the California State Association of Counties. “We are triaging right now between testing, contact tracing and vaccination, and it’s impacting the response to the pandemic.”
Newsom’s budget proposal is the first step in a months-long negotiation process with the Democratic-controlled legislature, which has until June 15 to adopt the state budget that takes effect July 1. Lawmakers have become increasingly frustrated with the governor’s response to the pandemic, including his unilateral spending decisions in response to the emergency. Newsom is also facing a burgeoning recall effort, backed by heavyweight Republicans such as former San Diego Mayor Kevin Faulconer, who is considering challenging Newsom in the 2022 California gubernatorial election.
Newsom said he expects to make some tough calls on spending even though the state anticipates a $15 billion budget surplus for the coming fiscal year, largely because a state fiscal analysis projected deficits in subsequent years.
“While we are enjoying the fruits of a lot of one-time energy and surplus, it’s not permanent and we have to be mindful of over-committing,” Newsom said, explaining why he didn’t include funding to expand Medicaid to more unauthorized immigrants.
Some lawmakers say they will nonetheless press Newsom to use higher-than-expected revenues — and perhaps seek new taxes — to expand health coverage to more Californians.
The following health care proposals factor heavily into Newsom’s 2021-22 budget proposal.
Newsom committed $4.4 billion in his budget to vaccine distribution, increased testing, contact tracing and other short-term pandemic expenses. Because that spending is related to the public health emergency, the state expects at least 75% to be reimbursed by the federal government and insurance payments.
He also proposed $52 million to fund costs at state-run surge hospitals, including support staff. And he is asking lawmakers to sign off on a covid relief package that would provide funding before the start of the fiscal year in July. It would include $2 billion to help school districts reopen classrooms to in-person instruction beginning in February by paying for protective equipment, ventilation systems and adequate testing. It would also commit billions to economic recovery, such as stimulus payments for individuals, and grants and tax credits for struggling small businesses.
Newsom also wants to increase the budget for the Department of Industrial Relations by $23 million to fund up to 113 additional workplace inspectors at the California Division of Occupational Safety and Health to police health order violations at businesses and enforce workplace safety laws.
Spending for Medi-Cal, the state’s Medicaid program for low-income residents, is expected to grow in the coming year because of the economic impact of the pandemic — as is its enrollment. The program has roughly 13 million enrollees, or about one-third of the state population.
In the coming year, Newsom will also press forward with a major overhaul of Medi-Cal, through a project called CalAIM, to provide new benefits emphasizing mental health care and substance use treatment, and pay for some nontraditional costs such as housing assistance. The hope is the program would divert homeless and other vulnerable people away from expensive emergency room care and keep them out of jail.
State Medi-Cal officials estimate the program would cost $1.1 billion for the first year. The state is working with the federal Centers for Medicare & Medicaid Services to obtain approval for the program.
Newsom also wants to expand Medi-Cal benefits to cover over-the-counter cold medicine and blood glucose monitors for people with diabetes. His budget includes $95 million for a major expansion of telehealth services that would permanently provide higher payments for virtual doctor visits.
Controlling Health Care Costs
Newsom is proposing a new state agency, the Office of Health Care Affordability, which he said would help control health care costs. He budgeted $63 million over the next three years for the office, which would set health care cost targets for the health care industry — along with financial penalties for failing to meet future targets.
Powerful health industry groups said they are still assessing whether they will support the proposal. But some expressed concern last year when Newsom floated the idea. Doctors and hospitals routinely fight proposals in Sacramento that might limit their revenue.
Newsom acknowledged Friday the task would be “tough.”
Battling Homelessness and Food Insecurity
Newsom is proposing a one-time infusion of $1.75 billion to battle homelessness.
Of that, Newsom said, $750 million would help counties purchase hotels and transform them into permanent housing for chronically homeless people. Another $750 million would allow counties to purchase facilities to treat people with mental illness or substance use disorders. And $250 million would help counties purchase and renovate homes for low-income older people.
Newsom’s budget also includes $30 million to help overwhelmed food banks and emergency food assistance programs.
Lawmakers said they plan to negotiate for even more funding for homelessness and safety-net programs.
“We absolutely need to significantly increase our investment to address homelessness because the need is so intense,” said Assembly member David Chiu (D-San Francisco). “And I don’t think there’s a single legislator who isn’t incredibly concerned about the food insecurity we’re seeing: lines around the block for food banks in what should be the wealthiest state in the country.”
Expanding Health Coverage
Newsom did not include money in his proposed budget to expand Medi-Cal to unauthorized immigrants age 65 and older. He had previously promised to fund the proposal, estimated to cost $350 million per year once fully implemented, but he said Friday the state cannot afford to commit to ongoing costs with a projected budget deficit starting in fiscal year 2022-23. California already offers full Medicaid benefits for income-eligible unauthorized immigrants up to age 26.
Some lawmakers and health care advocates countered that providing health insurance for undocumented immigrants would save lives and reduce costs, especially during the pandemic, and vowed to continue to fight for the expansion.
“To say we are disappointed is describing it very lightly,” said Orville Thomas, a lobbyist with the California Immigrant Policy Center. “These are Californians dying and getting sick at disproportionate rates during covid.”
USE OUR CONTENT
This story can be republished for free (details).
The nurses at Mission Hospital in Asheville, North Carolina, declared on March 6 — by filing the official paperwork — that they were ready to vote on the prospect of joining a national union. At the time, they were motivated by the desire for more nurses and support staff, and to have a voice in hospital decisions.
A week later, as the covid-19 pandemic bore down on the state, the effort was put on hold, and everyone scrambled to respond to the coronavirus. But the nurses’ long-standing concerns only became heightened during the crisis, and new issues they’d never considered suddenly became urgent problems.
Staffers struggled to find masks and other protective equipment, said nurses interviewed for this story. The hospital discouraged them from wearing masks one day and required masks 10 days later. The staff wasn’t consistently tested for covid and often not even notified when exposed to covid-positive patients. According to the nurses and a review of safety complaints made to federal regulators, the concerns persisted for months. And some nurses said the situation fueled doubts about whether hospital executives were prioritizing staff and patients, or the bottom line.
By the time the nurses held their election in September — six months after they had filed paperwork to do so — 70% voted to unionize. In a historically anti-union state with right-to-work laws and the second-least unionized workforce in the country, that margin of victory is a significant feat, said academic experts who study labor movements.
That it occurred during the pandemic is no coincidence.
For months now, front-line health workers across the country have faced a perpetual lack of personal protective equipment, or PPE, and inconsistent safety measures. Studies show they’re more likely to be infected by the coronavirus than the general population, and hundreds have died, according to reporting by KHN and The Guardian.
Many workers say employers and government systems that are meant to protect them have failed.
Research shows that health facilities with unions have better patient outcomes and are more likely to have inspections that can find and correct workplace hazards. One study found New York nursing homes with unionized workers had lower covid mortality rates, as well as better access to PPE and stronger infection control measures, than nonunion facilities.
Recognizing that, some workers — like the nurses at Mission Hospital — are forming new unions or thinking about organizing for the first time. Others, who already belong to a union, are taking more active leadership roles, voting to strike, launching public information campaigns and filing lawsuits against employers.
“The urgency and desperation we’ve heard from workers is at a pitch I haven’t experienced before in 20 years of this work,” said Cass Gualvez, organizing director for Service Employees International Union-United Healthcare Workers West in California. “We’ve talked to workers who said, ‘I was dead set against a union five years ago, but covid has changed that.’”
In response to union actions, many hospitals across the country have said worker safety is already their top priority, and unions are taking advantage of a difficult situation to divide staff and management, rather than working together.
Labor experts say it’s too soon to know if the outrage over working conditions will translate into an increase in union membership, but early indications suggest a small uptick. Of the approximately 1,500 petitions for union representation posted on the National Labor Relations Board website in 2020, 16% appear related to the health care field, up from 14% the previous year.
In Colorado, SEIU Local 105 health care organizing director Stephanie Felix-Sowy said her team is fielding dozens of calls a month from nonunion workers interested in joining. Not only are nurses and respiratory therapists reaching out, but dietary workers and cleaning staff are as well, including several from rural parts of the state where union representation has traditionally been low.
“The pandemic didn’t create most of the root problems they’re concerned about,” she said. “But it amplified them and the need to address them.”
A nurse for 30 years, Amy Waters had always been aware of a mostly unspoken but widespread sentiment that talking about unions could endanger her job. But after HCA Healthcare took over Mission Health in 2019, she saw nurses and support staff members being cut and she worried about the effect on patient care. Joining National Nurses United could help, she thought. During the pandemic, her fears only worsened. At times, nurses cared for seven patients at once, despite research indicating four is a reasonable number.
In a statement, Mission Health said it has adequate staffing and is aggressively recruiting nurses. “We have the beds, staffing, PPE supplies and equipment we need at this time and we are well-equipped to handle any potential surge,” spokesperson Nancy Lindell wrote. The hospital has required universal masking since March and requires staff members who test positive to stay home, she added.
Although the nurses didn’t vote to unionize until September, Waters said, they began acting collectively from the early days of the pandemic. They drafted a petition and sent a letter to administrators together. When the hospital agreed to provide advanced training on how to use PPE to protect against covid transmission, it was a small but significant victory, Waters said.
“Seeing that change brought a fair number of nurses who had still been undecided about the union to feel like, ‘Yeah, if we work together, we can make change,’” she said.
Old Concerns Heightened, New Issues Arise
Even as union membership in most industries has declined in recent years, health workers unions have remained relatively stable. Experts say it’s partly because of the focus on patient care issues, like safe staffing ratios, which resonate widely and have only grown during the pandemic.
At St. Mary Medical Center outside Philadelphia, short staffing led nurses to strike in November. Donna Halpern, a nurse on the cardiovascular and critical care unit, said staffing had been a point of negotiation with the hospital since the nurses joined the Pennsylvania Association of Staff Nurses and Allied Professionals in 2019. But with another surge of covid cases approaching, the nurses decided not to wait any longer to take action, she said.
A month later, officials with Trinity Health Mid-Atlantic, which owns the hospital, announced a tentative labor agreement with the union. The contract “gives nurses a voice in discussions on staffing while preserving the hospital’s right and authority to make all staffing decisions,” the hospital said in a statement.
In Colorado, where state inspection reports show understaffing led to a patient death at a suburban Denver hospital, SEIU Local 105 has launched a media campaign about unsafe practices by the hospital’s parent company, HealthOne. The union doesn’t represent HealthOne employees, but union leaders said they felt compelled to act after repeatedly hearing concerns.
In a statement, HealthOne said staffing levels are appropriate across its hospitals and it is continuing to recruit and hire staff members.
Covid is also raising entirely new issues for workers to organize around. At the forefront is the lack of PPE, which was noted in one-third of the health worker deaths catalogued by KHN and The Guardian.
Nurses at Albany Medical Center in New York picketed on Dec. 1 with signs demanding PPE and spoke about having to reuse N95 masks up to 20 times.
The hospital told KHN it follows federal guidelines for reprocessing masks, but intensive care nurse Jennifer Bejo said it feels unsafe.
At MultiCare Indigo Urgent Care clinics in Washington state, staff members were provided only surgical masks and face shields for months, even when performing covid tests and seeing covid patients, said Dr. Brian Fox, who works at the clinics and is a member of the Union of American Physicians and Dentists. The company agreed to provide N95 masks after staffers went on a two-day strike in November.
MultiCare said it found another vendor for N95s in early December and is in the process of distributing them.
PPE has also become a rallying point for nonunion workers. At a November event handing out PPE in El Paso, Texas, more than 60 workers showed up in the first hour, said SEIU Texas President Elsa Caballero. Many were not union members, she said, but by the end of the day, dozens had signed membership cards to join.
Small Successes, Gradual Movement
Organized labor is not a panacea, union officials admit. Their members have faced PPE shortages and high infection rates throughout the pandemic, too. But collective action can help workers push for and achieve change, they said.
National Nurses United and the National Union of Healthcare Workers said they’ve each seen an influx in calls from nonmembers, but whether that results in more union elections is yet to be seen.
David Zonderman, an expert in labor history at North Carolina State University, said safety concerns like factory fires and mine collapses have often galvanized collective action in the past, as workers felt their lives were endangered. But labor laws can make it difficult to organize, he said, and many efforts to unionize are unsuccessful.
Health care employers, in particular, are known to launch aggressive and well-funded anti-union campaigns, said Rebecca Givan, a labor studies expert at Rutgers university. Still, workers might be more motivated by what they witnessed during the pandemic, she said.
“An experience like treating patients in this pandemic will change a health care worker forever,” Givan said, “and will have an impact on their willingness to speak out, to go on strike and to unionize if needed.”
USE OUR CONTENT
This story can be republished for free (details).
El 20 de enero, con el control del Senado y la Cámara de Representantes, tendrán el poder de elegir qué propuestas de salud se votarán en el Congreso.
Las victorias del reverendo Raphael Warnock y Jon Ossoff en Georgia dieron a los demócratas dos escaños más en el Senado y la ventaja en un Senado dividido 50-50. Cuando la vicepresidenta electa, Kamala Harris, jure el cargo, su voto servirá como desempate, convirtiéndose así en el voto 51 de los demócratas.
Pero este estrecho margen de votos no eliminará el “filibusteo” (discursos obstruccionistas y dilatorios), lo que significa que los demócratas no tendrán suficientes votos para aprobar muchos de sus planes sin los republicanos.
Eso pondrá en peligro muchas propuestas demócratas de salud, como la de ofrecer a los estadounidenses una opción de seguro público patrocinada por el gobierno, y complicará los esfuerzos para aprobar más ayudas para la pandemia.
Queda por ver si los legisladores serán más proclives al compromiso después que una turba pro-Trump invadiera el Capitolio, el 6 de enero, atacando a la policía y dañando propiedad federal. Hubo cinco muertos.
Los estrechos márgenes de los demócratas en el Senado y en la Cámara de Representantes — donde pueden permitirse perder cuatro votos y aun así aprobar una legislación— también darán más influencia a algunos legisladores que, al no estar de acuerdo con los líderes de sus partidos, tendrán un incentivo para impulsar sus propias agendas a cambio de sus votos.
Habrá poco espacio para los desacuerdos intrapartidarios; y los demócratas dejaron claro, durante las primarias presidenciales, que no están todos de acuerdo sobre cómo lograr sus objetivos de salud pública.
En menos de dos semanas, los demócratas dirigirán los comités encargados de establecer la legislación sobre salud y de examinar a los nominados de Biden en esta área.
El control del Comité de Salud, Educación, Trabajo y Pensiones del Senado pasará a la senadora Patty Murray, demócrata de Washington, quien negoció el acuerdo de 2013 con el entonces presidente de la Cámara de Representantes, Paul Ryan, que puso fin a un largo cierre del gobierno, entre otros acuerdos bipartidistas.
En 2019, Murray y el presidente republicano del comité, el senador Lamar Alexander, de Tennessee, introdujeron un amplio paquete legislativo para reducir los costos de salud. Entre sus propuestas se encontraba una iniciativa para bajar los precios de los medicamentos recetados, mediante la eliminación de las lagunas legales que permiten a los fabricantes de medicamentos de marca bloquear a la competencia.
Durante una entrevista, antes de que los demócratas se aseguren el Senado, Murray dijo que el trabajo de su comité se centrará en los problemas que impiden a los estadounidenses recibir un tratamiento médico equitativo y asequible.
La prioridad, dijo, serán las disparidades raciales, evidenciadas por los desproporcionados índices de mortalidad entre las madres de raza negras, y entre las comunidades de color, que sufren los peores impactos de la pandemia de covid-19.
“No todos los que acuden al médico reciben la misma atención, sienten el mismo nivel de comodidad y muchas veces no se les cree”, dijo Murray.
Murray aseguró que presionará a los senadores para que consideren el impacto en las comunidades de color de cada pieza legislativa. “Esa será la cuestión en cada paso que demos”, añadió.
El miércoles 6, pidió a los republicanos que se incorporen a la lucha contra la pandemia “con políticas que ayuden directamente a los que más sufren y que nos ayuden a salir de esta crisis con más fortaleza y justicia”.
“Con una administración Biden-Harris y una mayoría demócrata en el Senado, los desafíos que enfrentamos no serán menores, pero finalmente tenemos la oportunidad de enfrentarlos y comenzar a tomar medidas”, declaró Murray. “Estoy deseando ponerme manos a la obra”.
El Comité de Finanzas del Senado, que supervisa Medicare, Medicaid y las políticas fiscales relacionadas con la salud, estará encabezado por el senador Ron Wyden, demócrata de Oregon.
Si bien el comité HELP también celebrará una audiencia de confirmación para Xavier Becerra, el candidato de Biden a la Secretaría del Departamento de Salud y Servicios Humanos; es el Comité de Finanzas el que votará para avanzar su confirmación.
En diciembre, los republicanos del Senado amenazaron con retrasar la nominación de Becerra antes de que Biden lo anunciara oficialmente. Los republicanos le reprochan a Becerra su falta de experiencia en el campo de la salud, cuestionan su apoyo a un sistema de salud de un solo pagador y se oponen a su defensa del derecho al aborto.
Como fiscal general de California, Becerra se enfrentó a las demandas presentadas por los funcionarios estatales republicanos contra la Ley de Cuidado de Salud A Bajo Precio (ACA).
Pero se espera que la escasa ventaja de los demócratas en el Senado sea suficiente para rechazar las objeciones de los republicanos a la nominación.
El mes pasado, Wyden alabó el compromiso de Becerra para responder a la pandemia, proteger la cobertura de los cuidados de salud y abordar las disparidades raciales; y dijo que esperaba con interés la audiencia de Becerra “para que pueda ponerse a trabajar y empezar a ayudar a la gente durante esta crisis sin precedentes”.
Además, después de meses de denunciar los fracasos de la administración Trump en el manejo de la pandemia, los demócratas controlarán qué proyectos de ley de ayuda se votarán.
El paquete del mes pasado no incluyó sus demandas de más fondos para los gobiernos estatales y locales, y los republicanos de la Cámara de Representantes bloquearon una iniciativa demócrata que pretendía aumentar los cheques de estímulo de $600 a $2,000.
Los demócratas se han unido en sus demandas de más ayuda, aunque a veces han estado en desacuerdo sobre cómo llevarla a cabo.
En el otoño, con las elecciones cerca y sin ningún acuerdo a la vista, los demócratas moderados, que buscaban ganar su propia elección, presionaron a la presidenta de la Cámara de Representantes, Nancy Pelosi, para que abandonara las negociaciones por un paquete de ayuda de $2,2 billones, que los republicanos calificaron como un fracaso, y aprobara una ayuda más modesta pero desesperadamente necesaria.
“Tanto el liderazgo demócrata, como el republicano, ha metido la pata. Todos son responsables”, declaró a Politico el representante Max Rose, demócrata de Nueva York. “Hagan algo ¡Hagan algo!” Rose perdió la reelección.
Voces más progresistas, como la de la representante Alexandria Ocasio-Cortez, demócrata de Nueva York, y el senador Bernie Sanders, independiente de Vermont, han presionado a favor de una ayuda más generosa, con mayores cheques de estímulo.
Más allá de la pandemia, el liderazgo demócrata ha mencionado el precio de los medicamentos como otra área de acción. Pero una de sus propuestas más populares, que autorizaría al gobierno federal a negociar los precios de los medicamentos para quienes están en Medicare, es poco probable que atraiga los votos republicanos que necesitaría.
Cuando los demócratas de la Cámara de Representantes aprobaron una de estas propuestas en 2019, los senadores republicanos aseguraron que ellos nunca la aprobarían.
Los miembros del ala más progresista de los demócratas, por su parte, argumentaron que la propuesta no era suficientemente agresiva.
Sin embargo, después de años de esfuerzos republicanos por socavar ACA, parece probable que la estabilización de la ley pueda cobrar fuerza en un Congreso controlado por los demócratas.
La Cámara de Representantes aprobó, el verano pasado, una legislación destinada a aumentar la cobertura y la asequibilidad, incluyendo la limitación de los costos de los seguros a no más del 8,5% de los ingresos y la ampliación de los subsidios.
Legisladores como Murray y Wyden se han apresurado a señalar que las consecuencias devastadoras de la pandemia, la pérdida de puestos de trabajo y la pérdida de cobertura del seguro, por nombrar sólo dos, han puesto de relieve la necesidad de fortalecer el sistema de salud.
USE OUR CONTENT
This story can be republished for free (details).
In the summer of 2020, Cotiviti released a new health risk map to help determine which states might see serious, medically attended novel coronavirus (COVID-19) cases. At the time, we were interested in measuring the impact of underlying conditions on different stages of coronavirus clinical progression, especially the end stage of mortality. After considering the publicly available data on infection rates and the well-researched effects of comorbid conditions on mortality rates, we shifted our attention to the middle of the clinical progression path, including ambulatory, emergency, and inpatient care. These areas provide the best actionable insights to understand and prevent clinical progression toward death.
2020 was the year that changed everything, and as the new year begins many are wondering what awaits the world in 2021. Impetus Digital co-founder and CEO Natalie Yeadon reflects on the last 12 months and shares her views on the healthcare, research and digital changes that could be here to stay.
I think it is fair to say that 2020 will not be particularly missed by anyone. Many started the year with big plans, whether for overseas trips, weddings, or industry events, and then the unthinkable happened. While the world first heard of the novel coronavirus in late 2019, it was not until 11 March 2020 that it was declared a global pandemic and it finally sank in just how serious of a threat it was. But how will the world continue to change in 2021?
Major global events
COVID-19 has amplified many of the issues that society was already facing. Although the pandemic has largely taken the media’s focus away from the climate crisis, it has given us a preview of what is to come if we do not stop exploiting the planet and our wildlife. Indeed, 2020 brought new record forest fires and extreme weather events.
In addition, 2020 was the year where social justice (not least in the form of Black Lives Matter protests) was brought into focus. Racial discrimination and bias were also uncovered in healthcare, with stark differences in COVID-19 rates and mortality between different ethnicities in many countries.
COVID-19 has widened the already large class divides seen between white-collar and service workers, with the former typically having the option of working from home and taking the recommended social distancing precautions. Conversely, the latter group is largely being forced to carry on with their work with little protection and low compensation, if they even have a job to go to after many smaller businesses closed their doors.
Public health has been politicised
Somehow, in 2020, wearing a mask to prevent the spread of a highly contagious disease became a controversial and political issue. People were asked to stay home, watch Netflix, and bake sourdough bread to protect those who are vulnerable, yet photos of packed bars and sports stadiums soon emerged and anti-masking protests were held across the world.
Epidemiologists, researchers, and clinicians are now household names, with people like Dr Anthony Fauci and Sweden’s Anders Tegnell drawing their fair share of both praise and criticism domestically and internationally. Countries’ strategies to contain the spread of the virus have been debated and criticised, and it will likely be years before we will be able to say which approaches were “right” and “wrong”.
“On the upside, the pandemic has brought enhanced focus to mental health issues and innovative approaches on how to best address these. If we can keep the momentum going and retain this focus post-COVID, perhaps the stigma around mental health can be lifted and better treatment strategies can emerge”
Mental health focus
The secondary effects on mental health during the pandemic are vast. We are already seeing increased rates of depression and anxiety because of the pandemic, and there are no signs of this slowing down. Women are especially impacted, disproportionately having to take on childcare or home-schooling compared to their male counterparts.
On the upside, the pandemic has brought enhanced focus to these issues and innovative approaches on how to best address mental health. If we can keep the momentum going and retain this focus post-COVID, perhaps the stigma can be lifted and better treatment strategies can emerge.
United global research
Another positive note is that the pandemic has accelerated laboratory and clinical trial collaboration far beyond what has ever been seen before. From the onset of the pandemic, scientists have been openly sharing their data with investigators from other centres or countries. It has also shown that the time it takes to get a drug to market can be substantially reduced when there is enough funding and political will. How this will affect clinical trials and regulatory approvals in the future remains to be seen, but there is reason to be optimistic.
Healthcare goes virtual
Before 2020, telehealth appointments were few and far between, with many clinics not set up for these services. Since then, the growth of telemedicine has been exponential. Another aspect of healthcare that has had to adapt is the way we monitor chronic conditions. Older patients or those with co-morbidities are at higher risk of severe COVID-19, so frequent clinic visits for routine blood pressure measurements are not always feasible. As a result, we have seen a dramatic increase in the interest and uptake of remote monitoring devices such as wearables and mobile health apps. I predict that this is just the beginning of healthcare’s virtualisation and am excited to see what the new year has in store.
Remote work is the future
Another major change in 2020 was of course the sudden move to remote work. For many, it was a 180-degree shift from business as usual. Interestingly, in a Canadian survey, the majority of respondents (55%) expected at least some of the workforce to remain remote in a substantial way after the pandemic is over, while only 17% expected all staff to be onsite five days a week. Further, major companies like Twitter have announced that employees will be able to work from home permanently, signalling a clear change in the way that we do work. While not without challenges, I see remote work becoming a mainstay due to its greater flexibility and convenience for workers.
Virtual events are rapidly improving
Finally, the ways that pharmaceutical and scientific communities attend meetings and events completely changed in 2020. Virtual meetings such as advisory boards and steering committees were already popular before this year but were often accompanied by in-person meetings. We have now seen without a doubt that it is possible to meet the same objectives virtually, often more effectively and at a lower cost.
The biggest change, however, is the way we now attend larger events such as conferences, congresses, and medical education events. There is no shortage of online conference solutions available, but there is still much to improve on. For example, some aspects of in-person events are not always there or are poor substitutes for the real thing.
Ideally, virtual event platforms should be comprehensive so that everything you need is in the same place. The layout, branding, and inclusions should be completely customisable to your needs, and it should come with all aspects of in-person events such as networking, breakout workshops, exhibitor booths, and poster sessions. The good news is that these types of platforms are getting better by the day, and so are the virtual events that they host.
What have we learned from the last year?
The past 12 months have shown that firstly, we live in a highly polarised world where science and public health are up for debate. Secondly, crisis leads to innovation and finally digital health technologies are the future with remote work and virtual meetings here to stay.
Wishing you all a safe, happy, and healthy 2021.
About the author
Natalie Yeadon is the CEO and co-founder of Impetus Digital, where she helps life science clients virtualise their meetings and events and create authentic relationships with their customers.
The post 2021 – The healthcare changes here to stay appeared first on .
Patients have been asking for patient-centric trial solutions for years – the industry just hasn’t been listening. That’s according to Medidata’s Anthony Costello, who was bringing patient feedback into product design long before COVID-19. He tells us what insights pharma has been missing out on and how they can be harnessed to build better solutions.
COVID-19 might have forced the industry to leave behind its reticence around remote and decentralised trials, but according to Anthony Costello, senior vice president of mobile health at Medidata, this reticence wouldn’t have existed in the first place had the industry been genuinely listening to patients.
“Patients have not been saying anything new during COVID-19, but the difference is that the industry has woken up and started paying attention,” he says.
“Patients have long wanted more and better technology to use in studies so that they don’t have to visit sites so often, but the industry has been very reluctant to go in that direction.”
• Read the full article in pharmaphorum’s Deep Dive digital magazine
The post How patient insights are changing trial solutions appeared first on .
Keely Connolly thought she would be safe once the ambulance arrived at Hutchinson Regional Medical Center in Kansas.
She was having difficulty breathing because she’d had to miss a kidney dialysis treatment a few days earlier for lack of child care. Her potassium was dangerously high, putting her at risk of a heart attack. But she trusted she would be fine once she was admitted and dialysis was begun.
She panicked when a nurse told her that no beds were available and that she would have to be transferred — possibly more than 450 miles away to Denver. She had heard a rumor about a dialysis patient who died waiting for a bed at a hospital in Wichita, about an hour down the road.
“‘I don’t want to die in the ER,’” Connolly, 32, recalled thinking. “I just wanted them to fix me, but then the woman came in and said, ‘There are no beds.’ I got really scared and I didn’t know if they had time to get me anywhere else.”
When a bed was finally located 65 miles away in Salina, Connolly, who has kidney failure, was relieved but worried: How long would she be gone? Who would care for her young daughter? How would she get home? What would it all cost?
Connolly was caught in a situation experts have warned about since the beginning of the coronavirus pandemic: Covid-19 patients are overwhelming hospitals, squeezing space and staff needed to treat emergencies like Connolly’s.
While it has happened in pockets throughout the country since the spring, the pressure on hospitals is widespread now — reaching into both urban and rural communities at an alarming pace, even as local officials and citizens continue to slam public health departments and pandemic guidelines. Traveling nurses are hard to come by as their services are in high demand nationwide and their pay has escalated beyond the reach of some smaller hospitals.
“This is the first time since I have been here that we’ve had a scenario where multiple hospitals, for longer periods of time, are experiencing some kind of shortages,” said Cindy Samuelson, a senior vice president of the Kansas Hospital Association.
And it got worse after Connolly’s emergency in mid-November. The 14-day rolling average positive test rate in Reno County, where Hutchinson is the county seat, reached 46% on Dec. 22, though it has since come down to 24% as of Jan. 4, said D.J. Gering, data analyst for the Reno County Health Department. The results did not include inmates from the Hutchinson Correctional Center, the local state prison.
By Oct. 1, four covid deaths had been recorded in the county of about 62,000. By Jan. 4, the death toll since the pandemic began had jumped to 105. For comparison, Gering said, Reno County had 19 deaths attributed to pneumonia and influenza combined in all of 2019.
Hospitalizations at the 190-licensed-bed Hutchinson Regional Medical Center increased 800% from mid-October to mid-December then started to temper at the end of the month, said Chuck Welch, vice president of Hutchinson Regional Medical System.
“I hate to be overly optimistic until we are well past the possible holiday surge from Christmas and New Year’s,” he said in an email.
Operating between 90% and 95% capacity, the hospital is providing care to patients with a multitude of needs and still has room to expand. The problem, Welch said, has been staffing.
Competing for traveling nurses and specialists against larger hospitals to backfill positions open from sick or quarantining staffers has been challenging. When the hospital has been faced with increasing numbers of covid patients seeking emergency care, handling “normal” emergencies like Connolly’s has been much more difficult, Welch said.
While staffers work to transfer patients as close to home as possible, with so many hospitals in Kansas beyond capacity, it has become more common than before to transfer as far away as Colorado and Nebraska. Such transfers require medical flights, which are typically not covered by insurance and can cost patients upward of $50,000, Welch said.
“It is collateral damage,” he said. “It is something that has sort of been lost out of the narrative of these folks where everybody is relieved when we find them a bed. Everybody forgets about the downstream impact of the cost of those transports.”
Connolly recovered after three days in the Salina hospital. But the question still looms about the costs for her emergency care. Connolly had left her job as a corrections officer at the prison in September because coronavirus cases began to spike inside. Without her employer-sponsored health insurance, Connolly now relies on Medicaid and Medicare Part A, which means she is responsible for more out-of-pocket costs for things like pharmaceuticals and ambulance services.
Connolly worries so much about her finances that she’s been too scared to look at her recent ambulance bills. Being a single parent, living with kidney failure and undergoing dialysis during a pandemic are her primary concerns.
As with many underlying conditions, covid-19 appears to pose an extra risk for people with kidney failure and patients undergoing dialysis, said Dr. Alan Kliger, a nephrologist at Yale University and co-chair of the American Society of Nephrology’s COVID-19 Response Team.
Data from New York and Europe early in the pandemic showed that about 1 in 5 dialysis patients who acquired covid died, he said. However, the complication and mortality rates have fallen in recent months, according to unpublished survey data from members of the nephrology society, Kliger said.
“It’s still a high risk,” he said.
For Connolly, the pandemic has also complicated her three-times-a-week 3½-hour dialysis schedule. For example, when her daughter’s kindergarten class was told to quarantine for 14 days after an in-class exposure to the virus, she had to scramble to find babysitters so she could attend dialysis.
“I don’t want too many people to watch her because of covid,” Connolly said of her daughter, adding that she is lucky the girl’s father is supportive. But he can’t always step in, which means if Connolly can’t find a sitter, she may have to skip or reschedule dialysis.
Connolly wants to get another job. But living in a county where so many refuse to wear masks and some elected leaders accuse the health department of providing false information about covid testing rates and statistics makes her afraid to be in public more than necessary.
“I want to work,” she said. “I had a good job. I served my community. The reality of knowing how bad it is at the hospital — I have seen it firsthand. And now I am out and seeing people without masks and I am thinking, ‘If I get this and I have to go back, I may not leave the hospital next time.’”
The reality, said Kliger, Welch and others, is that while the virus runs rampant, hospitals will struggle to keep up, which potentially endangers medical staffers and anyone needing hospital care — and the virus will continue to spread as long as people refuse to wear masks and disregard scientifically sound guidelines.
Connolly said she would love to see more empathy for people who have underlying health concerns like her from those resisting safety measures such as masks.
“Even if they think that it doesn’t work, what if it does? What if it could? I don’t really understand how wearing a mask is going to take so much out of your day, compared to someone who is immunocompromised and gets sick,” said Connolly. “Or you lose your grandma, or your parent. That’s going to affect your life a lot longer than wearing a mask for a little while.”
USE OUR CONTENT
This story can be republished for free (details).
The pandemic left McDermott feeling especially lonely. She restricted social interactions because her fatty liver disease put her at greater risk of complications should she contract covid-19. The 26-year-old Santa Cruz resident stopped regularly eating and taking her psychiatric medications, and contemplated suicide.
When McDermott’s thoughts grew increasingly dark in June, she checked into Second Story, a mental health program based in a home not far from her own, where she finds nonclinical support in a peaceful environment from people who have faced similar challenges.
Second Story is what is known as a “peer respite,” a welcoming place where people can stay when they’re experiencing or nearing a mental health crisis. Betting that a low-key wellness approach, coupled with empathy from people who have “been there,” can help people in distress recover, this unorthodox strategy has gained popularity in recent years as the nation grapples with a severe shortage of psychiatric beds that has been exacerbated by the pandemic.
Peer respites allow guests to avoid psychiatric hospitalization and emergency department visits. They now operate in at least 14 states. California has five, in the San Francisco Bay Area and Los Angeles County.
“When things are really tough and you need extra support but you don’t need hospitalization, where’s that middle ground?” asked Keris Myrick, founder of Hacienda of Hope, a peer respite in Long Beach, California.
People with serious mental illness are more likely to experience emotional distress in the pandemic than the general population, said Dr. Benjamin Druss, a psychiatrist and professor at Emory University’s public health school, elaborating that they tend to have smaller social networks and more medical problems.
That was the case with McDermott. “I don’t have a full-on relationship with my family. My friends are my family,” she said. She yearned to “give them a hug, see their smile or stand close and take a selfie.”
The next best thing was Second Story, located in a pewter-gray split-level, five-bedroom house in Aptos, a quaint beach community near McDermott’s Santa Cruz home.
Peer respites offer people in distress short-term (usually up to two weeks), round-the-clock emotional support from peers — people who have experienced mental health conditions and are trained and often certified by states to support others with similar issues — and activities like arts, meditation and support groups.
“You can’t tell who’s the guest and who’s the staff. We don’t wear uniforms or badges,” said Angelica Garcia-Guerrero, associate director of Hacienda of Hope’s parent organization.
Peer respites are free for guests but rarely covered by insurance. States and counties typically pick up the tab. Hacienda of Hope’s $900,000 annual operating costs are covered by Los Angeles County through the Mental Health Services Act, a policy that directs proceeds from a statewide tax on people who earn more than $1 million annually to behavioral health programs.
In September, California Gov. Gavin Newsom signed a bill that would establish a statewide certification process for mental health peer providers by July 2022.
For now, however, peer respite staff members in California are not licensed or certified. Peer respites typically don’t offer clinical care or dispense psychiatric drugs, though guests can bring theirs. Peers share personal stories with guests but avoid labeling them with diagnoses. Guests must come — and can leave — voluntarily. Some respites have few restrictions on who can stay; others don’t allow guests who express suicidal thoughts or are homeless.
Peer respite is one of several types of programs that divert people facing behavioral health crises from the hospital, but the only one without clinical involvement, said Travis Atkinson, a consultant at TBD Solutions, a behavioral health care company. The first peer respites arose around 2000, said Laysha Ostrow, CEO of Live & Learn, which conducts behavioral health research.
The approach seems to be expanding. Live & Learn counts 33 peer respites today in the U.S., up from 19 six years ago. All are overseen and staffed by people with histories of psychiatric disorders. About a dozen other programs employ a mix of peers and laypeople who don’t have psychiatric diagnoses, or aren’t peer-led, Atkinson said.
Though she had stayed at Second Story several times over the past five years, McDermott hesitated to return during the pandemic. However, she felt reassured after learning that guests were required to wear a mask in common areas and get a covid test before their stay. To ensure physical distancing, the respite reduced capacity from six to five guests at a time.
During her two-week stay, McDermott played with the respite’s two cats and piano — activities she found therapeutic. But most helpful was talking to peers in a way she couldn’t with her mental health providers, she said. In the past, McDermott said, she had been involuntarily admitted to a psychiatric hospital after she expressed suicidal thoughts. When she shared similar sentiments with Second Story peers, they offered to talk, or call the hospital if she wanted.
“They were willing to listen,” she said. “But they’re not forceful about helping.”
By the end of the visit, McDermott said that she felt understood and her loneliness and suicidal feelings had waned. She started eating and taking her medications more consistently, she said.
The small number of studies on respites have found that guests had fewer hospitalizations and accounted for lower Medicaid spending for nearly a year after a respite stay than people with similar conditions who did not stay in a respite. Respite visitors spent less time in the hospital and emergency room the longer they stayed in the respite.
Financial struggles and opposition from neighbors have hindered the growth of respites, however. Live & Learn said that although five peer respites have been created since 2018, at least two others closed because of budget cuts.
Neighbors have challenged nearby respite placements in a few instances. Santa Cruz-area media outlets reported in 2019 that Second Story neighbors had voiced safety concerns with the respite. Neighbor Tony Crane told California Healthline that guests have used drugs and consumed alcohol in the neighborhood, and he worried that peers are not licensed or certified to support people in crisis. He felt it was too risky to let his children ride their bikes near the respite when they were younger.
In a written response, Monica Martinez, whose organization runs Second Story, said neighbors often target community mental health programs because of concerns that “come from misconceptions and stigma surrounding those seeking mental health support.”
Many respites are struggling with increased demand and decreased availability during the pandemic. Sherry Jenkins Tucker, executive director of Georgia Mental Health Consumer Network, said its four respites have had to reduce capacity to enable physical distancing, despite increased demand for services. Other respites have temporarily suspended stays because of the pandemic.
McDermott said her mental health had improved since staying at Second Story in June, but she still struggles with isolation amid the pandemic. “Holidays are hard for me,” said McDermott, who returned to Second Story in November. “I really wanted to be able to have Thanksgiving with people.”
USE OUR CONTENT
This story can be republished for free (details).
“You want to be able to treat anaphylaxis,” said Dr. Mitchell Grayson, an allergist-immunologist with Nationwide Children’s Hospital in Columbus, Ohio. “I hope they’re in a place where an ambulance can arrive within five to 10 minutes.”
Of the more than 6 million people in the U.S. who have received shots of the two new covid vaccines, at least 29 have suffered anaphylaxis, a severe and dangerous reaction that can constrict airways and send the body into shock, according to the Centers for Disease Control and Prevention.
Such incidents have been rare — about 5.5 cases for every million doses of vaccine administered in the U.S. between mid-December and early January — and the patients recovered. For most people, the risk of getting the coronavirus is far higher than the risk of a vaccine reaction and is not a reason to avoid the shots, Grayson said.
Still, the rate of anaphylaxis so far is about five times higher for the covid vaccines than for flu shots, and some of those stricken had no history of allergic reactions. In this early phase of the vaccine rollout, all the patients were treated in hospitals and health centers that could offer immediate access to full-service emergency care.
As states look to scale up distribution, the shots will be administered by a varied assortment of professionals at venues including drugstores, dental offices and temporary sites attended by National Guard troops, among others. Health officials say every site involved in the wider community rollout must be able to recognize problems and have the training and equipment to respond swiftly if something goes wrong.
“We are really pushing to make sure that anybody administering vaccines needs not just to have the EpiPen available but, frankly, to know how to use it,” said Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, in a call with reporters. She was referring to a common epinephrine injector that many people with severe allergies carry with them. Those health care workers must also know the warning signs of the need for advanced care, she added.
Anaphylaxis typically occurs within minutes and can cause hives, nausea, vomiting, dizziness or fainting, and life-threatening problems such as low blood pressure and constricted airways. Initial treatment is an injection of epinephrine, or adrenalin, to reduce the body’s allergic response. However, severely affected patients can require intensive treatments including oxygen, IV antihistamines and steroids such as cortisone to save their lives. Community sites are unlikely to have these treatments on hand and would need quick access to emergency responders.
Anybody administering vaccines needs not just to have the EpiPen available, but, frankly, to know how to use it.
Dr. Nancy Messonnier, CDC
Scientists are still investigating what’s triggering the severe reactions to the Pfizer-BioNTech and Moderna mRNA vaccines. They suspect the culprit may be polyethylene glycol, or PEG, a component present in both vaccines that has been associated with allergic reactions.
Even as they call for education and support for providers, experts are urging the more than 50 million Americans with allergies — whether to foods, insect venom, medications or other vaccines — to be proactive about finding a venue that’s properly prepared. Before scheduling a vaccine, contact the site and ask pointed questions about its emergency precautions, said Dr. Kimberly Blumenthal, quality and safety officer for allergy at Massachusetts General Hospital.
“Ask the question: Do they have an anaphylaxis kit? Can they take vital signs?” she said. People who routinely carry EpiPens should remember to bring them when they are vaccinated, she added.
A CDC website details a list of equipment and medications that sites should have on hand and urges that all patients be observed for 15 minutes after vaccination or 30 minutes if they’re at higher risk for reactions. The list recommends — but does not require — that sites stock the more intensive treatments, such as IV fluids. People who experience severe reactions shouldn’t get the recommended second dose of the vaccine, the agency said.
“Appropriate medical treatment for severe allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following administration of an mRNA COVID-19 vaccine,” the site says.
Still, that’s a tall order, given the scope of the vaccination effort. The federal government is sending vaccines to more than 40,000 pharmacy locations involving 19 chains, including CVS, Walgreens, Costco and Rite Aid. At the same time, dozens of pop-up inoculation sites are ramping up in New York City, and drive-thru clinics have been set up in Ohio, Florida and other states.
Drive-thru sites, in particular, worry allergists like Blumenthal, who said it’s crucial to recognize symptoms of anaphylaxis quickly. “If you’re in a car, are you going to have your windows open? Where are the medicines? Are you in a parking lot?” she said. “It just sounds logistically more challenging.”
Ask the question: Do they have an anaphylaxis kit? Can they take vital signs?
Dr. Kimberly Blumenthal, Massachusetts General Hospital
In Columbus, more than 2,400 people had been vaccinated by Jan. 6 at a drive-thru clinic set up at the Ohio Expo Center. No allergic reactions have been reported, according to Kelli Newman, a spokesperson for Columbus Public Health. But if they occur, she said, health officials are prepared.
“We have a partnership with our EMS and they are observing those being vaccinated for 15 minutes to make sure there are no adverse reactions,” Newman said in an email. “They have two EMS trucks available with emergency equipment and epinephrine, if needed.”
Similarly, representatives for CVS Health and Walgreens said they have the staff and supplies to handle “rare but severe” reactions.
“We have emergency management protocols in place that are required for all vaccine providers, which, following a clinical assessment, may include administering epinephrine, calling 911 and administering CPR, if needed,” Rebekah Pajak, a spokesperson for Walgreens, said in an email.
If the vaccine sites have appropriately trained staffers, plus adequate supplies and equipment, the vast majority of people should opt for the shot, especially as the pandemic continues to surge, said Dr. David Lang, immediate past president of the American Academy of Allergy, Asthma & Immunology and chairman of the department of immunology at the Cleveland Clinic.
“The overwhelming likelihood is that you won’t have anaphylaxis and the overwhelming benefit far exceeds the risk for harm,” Lang said.
USE OUR CONTENT
This story can be republished for free (details).
Use Our Content
It can be republished for free.
Democrats have argued for more generous pandemic relief, more pressure on drugmakers to lower prices and more attention to systemic racism in health care. On Jan. 20, with control of the Senate and the House of Representatives, they’ll have the power to choose which health care proposals get a vote in Congress.
The victories of the Rev. Raphael Warnock and Jon Ossoff in Georgia last week gave Democrats two more Senate seats and the upper hand in the Senate’s now 50-50 split. After Vice President-elect Kamala Harris takes the oath of office, she will serve as the tiebreaker as needed — in effect, Democrats’ 51st vote.
But that vote count is too small to eliminate the filibuster, meaning Democrats will not have enough votes to pass many of their plans without Republicans. That will likely doom many Democratic health care proposals, like offering Americans a government-sponsored public insurance option, and complicate efforts to pass further pandemic relief.
It remains to be seen how willing lawmakers are to compromise with one another in the aftermath of a pro-Trump mob’s breach of the Capitol on Wednesday. Thursday, Democrats demanded the president’s removal for inciting rioters who disrupted the certification of President-elect Joe Biden’s victory, assaulted Capitol Police officers and damaged federal property. One demonstrator and a police officer were killed, and three demonstrators died of medical emergencies.
Democrats’ slim margins in the Senate and the House — where they can afford to lose only four votes and still pass legislation — will also give individual lawmakers more leverage, handing those who disagree with party leaders an incentive to push their own priorities in exchange for their votes. There will be little room for intraparty disagreements, and Democrats made it clear during the presidential primaries that they disagree about how to achieve their health care goals.
In less than two weeks, Democrats will lead the committees charged with marking up health care legislation and vetting Biden’s health nominees.
The change will hand control of the Senate Health, Education, Labor and Pensions Committee to Sen. Patty Murray (D-Wash.), who brokered the 2013 agreement with then-House Speaker Paul Ryan that ended a long government shutdown, among other bipartisan deals.
In 2019, Murray and the committee’s Republican chairman, Sen. Lamar Alexander of Tennessee, introduced a wide-ranging package to lower health costs for consumers. Among its proposals was an initiative to lower prescription drug prices by eliminating loopholes that allow brand-name drugmakers to block competition.
In an interview before Democrats secured the Senate, Murray said her committee work will be focused on the problems that prevent all Americans from receiving equitable, affordable treatment in health care. Racial disparities, evidenced by disproportionate mortality rates among Black mothers and among communities of color suffering the worst impacts of the pandemic, will be a priority, she said.
“Not everybody goes into the doctor and gets the same advice, feels the same comfort level and is believed,” Murray said.
Murray said she will press for senators to consider how any piece of legislation will affect communities of color. “It will be the question I ask about every step we take,” she said.
On Wednesday, she called out Republicans for standing in the way of fighting the pandemic “with policies that would directly help those struggling the most and would help us build back from this crisis stronger and fairer.”
“With a Biden-Harris Administration and a Senate Democratic majority, the challenges we face won’t get any less tough — but we’ve finally got the opportunity to face them head on and start taking action,” Murray said in a statement. “I can’t wait to start getting things done.”
The Senate Finance Committee, which oversees Medicare, Medicaid and health-related tax policies, will be run by Sen. Ron Wyden (D-Ore.). While the HELP committee will also hold a confirmation hearing for Biden’s nominee for secretary of the Department of Health and Human Services, Xavier Becerra, it is the Finance Committee that will vote to advance his confirmation.
Senate Republicans signaled they would delay considering Becerra’s nomination before Biden officially announced his name last month. Calling him unqualified due to his lack of a health care background, they questioned his support for a single-payer health care system and opposed his efforts to preserve abortion rights. As California’s attorney general, Becerra led efforts to fight lawsuits brought by Republican state officials against the Affordable Care Act.
But Democrats’ slim edge in the Senate is expected to be enough to drown out Republicans’ objections to the nomination. Last month, praising Becerra’s commitment to responding to the pandemic, protecting health care coverage and addressing racial disparities, Wyden said he looked forward to Becerra’s hearing “so he can get on the job and start helping people during this unprecedented crisis.”
Also, after months of decrying the Trump administration’s failures managing the pandemic, Democrats will control which relief bills get a vote.
Last month’s package did not include their demands for more funding for state and local governments, and House Republicans blocked a Democratic effort to increase stimulus checks to $2,000, from $600.
Democrats have been united in their calls for more assistance, though they have disagreed at times about how to push for it.
In the fall, with the election approaching and no deal in sight, moderate Democrats in tough races pushed for House Speaker Nancy Pelosi to abandon negotiations for a $2.2 trillion relief package that Republicans called a nonstarter in favor of passing more modest but desperately needed relief.
“Every member of the leadership team, Democrats and Republicans, have messed up. Everyone is accountable,” Rep. Max Rose (D-N.Y.) told Politico. “Get something done. Get something done!” He lost his bid for reelection.
More progressive voices like Rep. Alexandria Ocasio-Cortez (D-N.Y.) and Sen. Bernie Sanders (I-Vt.) have been a force for more generous aid, particularly larger stimulus checks.
Beyond the pandemic, top Democrats have mentioned drug pricing as another area ripe for action. But one of their most popular proposals, which would authorize the federal government to negotiate drug prices for those on Medicare, is unlikely to attract the Republican votes it would need. When House Democrats passed one such proposal in 2019, Senate Republicans vowed it would never pass.
Members of Democrats’ more progressive wing, for their part, argued the proposal may not go far enough.
After years of Republican efforts to undermine the Affordable Care Act, though, it looks likely that efforts to stabilize the law could gain more traction under a Democratic-controlled Congress. The House passed legislation last summer aimed at increasing coverage and affordability, including by capping insurance costs at no more than 8.5% of income and expanding subsidies.
Lawmakers like Murray and Wyden have been quick to point out that the pandemic’s devastating consequences — lost jobs and lost insurance coverage, to name just a couple — have only underscored the need to strengthen the health care system.
USE OUR CONTENT
This story can be republished for free (details).
Among those who received a first dose of varicella (n = 16 075), hepatitis A (n = 594 917), and hepatitis B (n = 590 445) vaccine, relatively few completed the series (55%–65% for hepatitis B vaccine and 40%–50% for hepatitis A and varicella vaccines in most age groups). Compliance was lowest among adolescents (35.9%) and Medicaid recipients (29.7%) who received varicella vaccine and among younger adult age groups who received hepatitis A vaccine (25%–35% across those age groups). Even among series completers, there was a relatively long interval of undervaccination between the first and last doses.
On the one hand, these vaccinations didn’t have the public attention of COVID-19 so perhaps compliance would be better. In particular, conditional on someone agreeing to a first COVID-19 vaccine–which will be a selected population given the (unfortunate) politics of the vaccine–perhaps second dose compliance would be higher than those observed in Nelson et al. for other vaccines. Additionally, there is evidence that the COVID-19 vaccines are very effective even after one dose. Nevertheless, this is some concerning historical precedent in the scientific literature.
Hat tip: Marginal Revolution.
En ninguna parte de la lista de personas prioritarias están los cónyuges de los funcionarios públicos.
Sin embargo, las primeras damas de Kentucky y West Virginia; Karen Pence, la esposa del vicepresidente Mike Pence; Jill Biden, la esposa del presidente electo Joe Biden; y Doug Emhoff, el esposo de la vicepresidenta electa Kamala Harris, estuvieron entre los primeros estadounidenses en recibir las vacunas que podrían salvar vidas.
Kentucky también vacunó a seis ex gobernadores y cuatro ex primeras damas, incluidos los padres de Andy Beshear, el actual gobernador demócrata.
Las primeras vacunas a los cónyuges provocaron indignación en las redes sociales, y varios usuarios de Twitter dijeron que no deberían poder “saltar la fila” antes que los médicos, enfermeras y personas mayores.
En la mayoría de los 29 estados que respondieron a las consultas de KHN (que llamó a las 50 oficinas de gobierno estatales), los principales funcionarios electos dijeron que ellos, y sus cónyuges, serán vacunados, pero han optado por esperar su turno detrás de electores más vulnerables.
Algunos miembros del Congreso de ambos partidos dijeron lo mismo cuando rechazaron las primeras dosis ofrecidas, en nombre de mantener al gobierno en funcionamiento.
Los gobernadores que recibieron las vacunas junto con sus cónyuges, y la oficina del vicepresidente, dijeron que querían dar el ejemplo a los residentes, generar confianza, salvar las divisiones ideológicas y demostrar que la vacuna es segura y eficaz.
Pero algunos cuestionan esta razón.
“Se parece más a hacer trampa. Los políticos pueden conseguir que los hospitales los vacunen bajo esta ilusión de generar confianza. Pero es una fachada”, dijo Arthur Caplan, profesor de bioética y director fundador de la división de ética médica de la Escuela de Medicina Grossman de la Universidad de Nueva York. “La gente podría decir: ‘Típica gente rica. No se puede confiar en ellos’. Esto socava la meta original”.
Caplan agregó que, de todos modos, el público no confía demasiado en los políticos, por lo que la vacunación de celebridades, líderes religiosos o figuras deportivas probablemente ayudaría más a aumentar la confianza en la vacuna.
Elvis Presley recibió la famosa vacuna contra la polio en 1956 para ganar la confianza de los escépticos; las acciones de las esposas de los gobernadores de ese período se recuerdan menos.
El doctor José Romero, presidente del Comité Asesor de Prácticas de Inmunización de los Centros para el Control y Prevención de Enfermedades (CDC), dijo en un correo electrónico a KHN que si bien su grupo proporciona un esquema para distribuir dosis limitadas de vacunas, “las jurisdicciones tienen la flexibilidad de hacer lo que sea apropiado para su población”.
Los funcionarios de Kentucky y Texas señalaron que el doctor Robert Redfield, director de los CDC, alentó a los gobernadores a vacunarse públicamente.
Nadie mencionó razones médicas para que sus cónyuges se vacunaran; los hospitales generalmente no están vacunando a los cónyuges de los profesionales médicos que han recibido la vacuna.
La oficina del gobernador de West Virginia, el republicano Jim Justice, publicó fotografías de él, su esposa, Cathy Justice, y otros funcionarios recibiendo las dosis. También posteó su propia vacunación en YouTube.
La oficina de Beshear en Kentucky también publicó fotos del gobernador recibiendo la vacuna en diciembre, el mismo día que su esposa, Britainy Beshear, y otros funcionarios estatales.
“Es cierto que hay dudas sobre las vacunas”, dijo Beshear en una reunión informativa sobre el coronavirus, el día en el que los ex gobernadores de Kentucky y sus cónyuges fueron vacunados. Aludió a un programa futuro que involucra a líderes religiosos y a otras personas influyentes.
Su padre, el ex gobernador demócrata Steve Beshear, publicó fotos de su vacunación en su página de Facebook, diciendo que él y su esposa, Jane Beshear, junto con otros ex gobernadores de Kentucky de ambos partidos y sus cónyuges, intervinieron en parte para alentar a los residentes a vacunarse.
Kentucky se encuentra actualmente en la primera etapa de distribución de vacunas, dirigida a trabajadores de salud y a residentes de centros de vida asistida. Se habían distribuido menos de 15,000 de las 58,500 dosis para estas residencias cuando los ex gobernadores y sus cónyuges fueron vacunados.
Tres Watson, ex director de comunicaciones del Partido Republicano de Kentucky, que fundó una firma de consultoría política, se mostró escéptico sobre las intenciones detrás del evento. Dijo que parecía ser un esfuerzo de relaciones públicas creado para que el gobernador pudiera vacunar a sus padres.
“Entiendo la continuidad del gobierno, pero las primeras damas no tienen parte en la continuidad del gobierno”, dijo. “Tienes que ajustarte a las prioridades. Una vez que empiezas a hacer excepciones, es cuando tienes problemas”.
Los funcionarios que representan al equipo de transición de Biden-Harris y otros tres estados donde se vacunaron los gobernadores (West Virginia y Texas liderados por republicanos, y Kansas liderado por un demócrata) no respondieron a KHN. El gobernador republicano de Alabama, Kay Ivey, recibió la vacuna y está divorciado.
Políticos de otros estados han hecho lo opuesto.
En Arkansas, el gobernador republicano Asa Hutchinson se centra en garantizar que los grupos de alta prioridad, como los trabajadores de salud, y el personal y residentes de centros de vida asistida, se vacunen, dijo la vocera LaConda Watson. “Él y su esposa recibirán la vacuna cuando sea su turno”, informó.
En Missouri, Kelli Jones, directora de comunicaciones del gobernador republicano Mike Parson, dijo en un correo electrónico que él y la primera dama tienen la intención de vacunarse. Al igual que los gobernadores de Colorado, Nevada y otros lugares, ambos se han recuperado de covid-19, dijo Jones, y “esperarán hasta que su grupo de edad sea elegible” según el plan estatal. Los médicos recomiendan las vacunas incluso para personas que ya han tenido covid.
Cissy Sanders, de 52 años, directora de eventos que vive en Austin, Texas, dijo que entiende por qué los legisladores deberían vacunarse. Su propio gobernador, el republicano Greg Abbott, se vacunó por televisión en vivo para infundir confianza, dijo su secretaria de prensa, Renae Eze, quien no quiso comentar si la esposa de Abbott se había vacunado.
Pero Sanders dijo que los cónyuges de los políticos no deben vacunarse antes que los residentes de un asilo, como su propia madre de 71 años. La madre de Sanders recibió la vacuna a fines de diciembre pero dijo que todavía hay demasiados residentes de hogares esperando en todo el país.
“¿Por qué un grupo que no es de alto riesgo, es decir, estos cónyuges, va a vacunarse antes que el grupo de mayor riesgo? ¿Quién toma estas decisiones?, se preguntó. “Los cónyuges de los políticos no han estado en la zona cero del virus. Los residentes de hogares sí”.
La corresponsal de Montana, Katheryn Houghton, la corresponsal de California Healthline, Angela Hart y los corresponsales Markian Hawlyruk y JoNel Aleccia colaboraron con esta historia.
USE OUR CONTENT
This story can be republished for free (details).
The UK has approved the Moderna coronavirus vaccine, hard on the heels of its go-ahead in Europe, although supplies are not expected to arrive for several weeks.
Moderna’s mRNA-1273 is the third COVID-19 vaccine to be approved for use by the Medicines and Healthcare products Regulatory Agency (MHRA) and is the second mRNA vaccine after Pfizer/BioNTech’s Comirnaty, which got the nod in December.
The UK government has ordered 17 million doses of the new vaccine, but none will be available before March, when Moderna is able to bring new production capacity online.
That means for now, the country’s immunisation programme will continue to rely on Comirnaty and the AstraZeneca/University of Oxford shot approved just before the New Year.
Around 1.5 million people in the UK have received at least one dose of either Pfizer/BioNTech or AZ vaccines, and that includes around a quarter of the over-80s age bracket who are particularly vulnerable to COVID-19.
The government’s target is to vaccinate 15 million people – around 22% of the total population – by the middle of next month.
The UK is facing a marked escalation in cases however, with the attest daily figures showing 68,000 new cases and 1,325 coronavirus-related deaths, and with a more transmissible strain of SARS-CoV-2 threatening to overwhelm the NHS.
The latest vaccine approval was welcomed by NHS Confederation chief executive Danny Mortimer, but he also stressed that “it does not mean the COVID-19 crisis today is over, especially as a major incident is declared in London, hospitalisations for coronavirus continue to rocket, and as many as one in 50 people are now infected.”
He went on: “It will…be weeks and months until the NHS feels the benefit of the vaccination programme.”
Moderna’s shot claimed conditional EU approval earlier this week, and the first supplies will start to arrive in Europe next week, according to Moderna. The European Commission has ordered 160 million doses, but Brexit means the UK will not benefit from the EU’s allocation and rollout plans.
Meanwhile, mRNA-1273 was also granted emergency use authorisation by the FDA on 18 December, with the US scheduled to receive 20 million doses by the end of 2020. Moderna has also said it aims to make 100 and 125 million more doses available in the first quarter of 2021, of which 85 to 100 million have been claimed by the US
The approval is based on trials showing mRNA-1273 had 94% efficacy in preventing disease, including in the elderly, roughly the same as the Pfizer/BioNTech shot and a little better than the 70% protection rate seen with AZ’s candidate.
The Oxfam charity welcomed that the UK now has more than enough vaccine on order to protect the entire population during 2021, but called for vaccine developers to share the science and technology behind them worldwide so less well-off countries don’t miss out.
“Nine in 10 people in the poorest countries are set to miss out on a vaccine unless the UK government and companies like Moderna urgently shift position,” said Oxfam’s health policy manager Anna Marriott.
“A failure to act is not just wrong but self-defeating and short-sighted – as long as the virus is allowed to spread in other parts of the world, public health and economic recovery in the UK will continue to be under threat,” she added.
The post Moderna’s COVID-19 vaccine is third approved in UK appeared first on .
The global pandemic has caused pharma companies to invest in digital marketing, as healthcare systems across the world adapt to strict lockdown rules. Once the global emergency ends, this trend will continue, argues pharmaphorum’s Richard Staines.
The global outbreak of COVID-19 has forced businesses to radically change their way of working. Healthcare companies have been in the vanguard of this change, with an enormous rise in the use of telehealth and all forms of digital communications.
With medical staff working tirelessly and lockdown restrictions in place across the world, the way pharma markets medications has changed, too.
Until 2020, pharma had lagged other industries in its investment in digital marketing. According to ethoseo, spending on digital projects is starting to catch up with levels in other industries.
In the US, TV advertising for pharma products is still a big business, but this is mainly aimed at patients. According to the figures compiled in the third quarter of last year, pharma brands were projected to spend around $10 billion in 2020 on digital advertising aimed at all groups including doctors, a compound annual growth rate of more than 13% since 2014.
A report from eMarketer came to an identical conclusion, estimating that US pharma would spend $9.53 billion on digital advertising in 2020, based on figures from the first nine months of the year.
This is an increase in 14.2% compared with 2019, and the digital spend is forecast to increase to $11.25 billion in 2021, an 18% increase.
According to Ian Hale, vice president of commercial content at Veeva, the change is driven by the sudden migration to digital services because of the pandemic.
Speaking from the company’s online European Veeva Commercial and Medical Summit late last year, he highlighted how more than three quarters of doctors now use iPads to find information. This switch to digital technology is meaning the pharma industry is having to change the way it communicates with physicians.
When pharma companies are trying to interact with doctors and inform them about the latest developments with medicines, the onus is on them to produce information in a format that suits the needs of today’s digitally savvy medics.
Gone are the days of long lunches with reps – what’s needed is accurate information that is fully compliant with marketing regulations, presented in most cases in a digital format, according to Hale. He added that information can be broken down into modules for use across global organisations and tailored to meet the needs of individual countries and their rules on marketing.
The way that reps engage with doctors will be very, Hale said, with an emphasis on efficiency. However, overall reps will engage more with healthcare professionals thanks to this change in approach.
“They are going to share content ahead of meetings. I don’t think there is going to be back-to-back zoom meetings,” said Hale.
Dan Atkins, vice president of digital innovation and insight at Shionogi Europe, told the conference in a keynote address that the company needed to get better insights into its customers as the company built its business in the region.
Using digital technology has allowed the company to keep track of its interactions with customers, with senior management and area managers also able to get feedback from the system.
David Herron, head of global digital platforms and operations at Teva, added that the company’s sales force was primarily working from home as a result of the pandemic. Digital tools have therefore become essential for the company to continue to interact with doctors.
The company had to use digital technology to link its sales workforce, who were already facing uncertainty because of rapidly evolving pandemic last year, with medics who were also experiencing similar anxieties. Herron added that the company is using strategies such as approved emails to interact with customers.
“Our ultimate goal is to be easy to do business with,” said Herron, focusing on areas such as digitising order management with pharmacies to streamline the sales process.
Going forward, Veeva’s Ian Hale said the processes are now available to reach out to medics using various different digital channels. With a robust compliance approval system in place the information can be sent out to many different geographies efficiently.
This can ensure the company is singing from the same hymn sheet across all areas and with all different media, while at the same time complying with varying marketing regulations.
Hale added: “Delivery across omnichannels is going to be key. You can approve compliantly and use that module to go in many areas.”
His message is that the shift towards digital marketing will remain in place after COVID. He concluded: “This is the way the industry is going. Many are asking how long to return back to the norm. For industry this means huge amounts of face-to-faces with customers.”
This was always a hugely expensive way of working and once pharma companies realise the cost savings and efficiencies through digital technology, they will be unlikely to let go of them once the pandemic recedes.
“Will we go back to that? I don’t think we will,” Hale said.
The post COVID-19 and the digital pharma marketing revolution appeared first on .
The Pfizer/BioNTech vaccine appears to work against an important mutation in the new coronavirus variants causing havoc in the UK and South Africa, according to research from the drugs giant.
Pfizer joined with scientists from the University of Texas Medical Branch to conduct the study, which indicated the vaccine was effective at neutralising virus with the mutation known as N501Y.
The mutation is responsible for greater transmissibility and there have been concerns it may also allow the virus to dodge the immune response produced as a result of the vaccination.
The study team tested blood taken from people who had received the mRNA vaccine developed by BioNTech and Pfizer.
However, findings are limited because it does not look at all mutations found in the new variants of the virus.
Pfizer’s chief scientific officer Philip Dormitzer noted that the vaccine has been found to work against 15 other mutations that the company has previously tested against.
He told Reuters: “So we’ve now tested 16 different mutations and none of them have really had any significant impact. That’s the good news.”
However he warned that this “doesn’t mean that the 17th won’t (have an impact)”.
He is also concerned about another mutation found in the South African variant, called E484K.
Researchers plan to run similar tests to check if the vaccine works against this and other mutations found in the UK and South African variants.
The advantage of the Pfizer/BioNTech vaccine is that it can be quickly tweaked to address any new mutations, and according to Reuters the changes could be made in as little as six weeks.
It’s not clear how the changes to the virus affect the rival vaccines developed by AstraZeneca/Oxford University and Moderna.
The post Pfizer/BioNTech vaccine may work against new virus mutation, scientists say appeared first on .
New data means that IL-6 drugs from Roche and Sanofi that had been all-but written off as coronavirus therapies will now be offered routinely to COVID-19 patients in intensive care in the UK.
The renaissance of the two therapies comes on the back of the REMAP-CAP trial, which found that the IL-6 inhibitors RoActemra (tocilizumab) and Kevzara (sarilumab) reduced the relative risk of death by 24% when administered to COVID-19 patients within 24 hours of entering intensive care, and reduce the time spent in hospital by seven to ten days.
Both RoActemra and Kevzara have failed to hit their objectives in earlier studies, leading to speculation that inhibiting IL-6 wasn’t a valid approach to treat severe COVID-19, but the new independent study turns that view on its head.
Crucially, their benefits seem to stack with that of the corticosteroid dexamethasone, the first drug to be shown to improve survival in seriously-ill COVID-19 patients in the RECOVERY trial.
The death rate for those in intensive care units on dexamethasone and respiratory support alone was 35%, but reduced to 28% when RoActemra was administered as well.
“The data shows that tocilizumab, and likely sarilumab, speed up and improve the odds of recovery in intensive care, which is crucial for helping to relieve pressure on intensive care and hospitals and saving lives,” said UK deputy chief medical officer Prof Jonathan Van-Tam.
The data has emerged as the government unveiled figures showing there are currently around 30,000 COVID-19 patients in hospitals, up nearly 40% on the previous peak during the first wave of the pandemic in April.
There are already ample supplies of RoActemra in the UK, so that drug in particular will be recommended for use “immediately” in patients admitted to intensive care with the virus, it said, saying that could potentially save “hundreds of lives”.
Roche welcomed the results, saying it was still in the process of analysing data from the COVACTA and EMPACTA trials, which generated negative and positive results for its drug respectively in patients hospitalised with COVID-19 associated pneumonia.
“Previous trials using IL-6 receptor agonists have showed no clear benefit on either disease progression or survival in COVID-19 patients, but those studies included less severely ill patients and started treatment at different stages in the disease course,” said Professor Anthony Gordon of Imperial College London, the trial’s lead investigator in the UK.
“A crucial difference may be that in our study, critically ill patients were enrolled within 24 hours of starting organ support. This highlights a potential early window for treatment where the sickest patients may gain the most benefit from immune modulation treatment,” he added.
REMAP-CAP has been running since 2016, with the aim of putting dozens of drugs through their paces to see if they can improve the prospects of people with severe community-acquired pneumonia (CAP) caused by influenza, but was expanded to include COVID-19 patients after the pandemic took hold.
It included more than 800 pneumonia patients in intensive care with suspected or proven COVID-19, of which around three-quarters were recruited from UK NHS trusts, but hasn’t yet been subjected to the scrutiny of peer review.
“This news is a positive step in the fight against COVID-19, giving doctors and the NHS another weapon in their armoury to treat critically ill patients,” said Marius Scholtz, chief medical officer at Roche Products Ltd. “It also increases the collective scientific understanding of COVID-19.”
The post IL-6 drugs do work in COVID-19, says UK, as it plans NHS use appeared first on .
As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses.
When the UK announced the approval of the Pfizer-BioNTech and Oxford/AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.
After months of turbulent lockdown measures, the dawn of approved vaccinations signalled hope COVID-19 could finally be under control.
Sadly, the chaos is continuing as the UK grapples with the emergence of a new variant of SARS-CoV-2, estimated to be up to 70% more transmissible than the previous form of the virus.
As cases surge, the UK’s decision to delay second doses of the vaccine beyond the 3-4 weeks tested and approved during Phase III clinical trials is causing widespread concern. Many believe the strategy is too risky – prioritising political expediency over science and using the British public as laboratory subjects during an already severe crisis.
The advice, which first came from the UK’s Joint Committee on Vaccination and Immunisation (JCVI), stated a maximum interval of 12 weeks should take place between the first and second doses of both Pfizer and AstraZeneca’s vaccines.
JCVI said this is likely to have a greater public health impact in the short term and reduce the number of preventable deaths from COVID-19.
“The rate of vaccine delivery in the UK is currently limited by vaccine supply rather than by workforce capacity,” said the committee. “An extended interval between vaccine doses together with initial prioritisation of the first vaccine dose would increase the flow of vaccine supply in the short term. This will allow for more first doses to be delivered to more people earlier.”
The advice has been endorsed by the UK’s four chief medical officers but has been met with backlash from the medical community. Many healthcare workers have aired grievances on Twitter protesting the changes.
The British Medical Association (BMA) also blasted the decision as “unreasonable and totally unfair”.
“The Government must see that it’s only right that existing bookings for the oldest and most vulnerable members of our society are honoured, and it must also as soon as possible publish a scientifically-validated justification for its new approach,” said the BMA.
“As doctors, we believe this can and should be done even as practices and the wider NHS step up the COVID-19 vaccination programme to deliver initial doses of vaccination to other vulnerable people, including frontline healthcare professionals – many of whom still have not even received their first vaccination.”
‘Erosion of public trust’’
The NHS Confederation, which represents leaders across the organisation, told pharmaphorum the government needed to be very clear in its communications with the public about exactly what they are being asked to do and why.
“We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorised dosing schedule for each COVID-19 vaccine”
“Protecting frontline staff from infection is vital to help them care for patients with COVID, as well as delivering the vaccination programme,” said NHS Confederation director Layla McCay. “However, there has been concern about changes to the vaccination schedule, which were announced at short notice and led to confusion and anxiety for patients and could lead to an erosion of public trust in healthcare providers. As always, NHS teams will pull out all the stops to respond to changing guidance, but the government must do more to explain the rationale for this change.”
Internationally, the decision has been met with scepticism. The FDA issued a statement regarding dosing schedules on 4 January 2021. “We know that some of these discussions about changing the dosing schedule or dose are based on a belief that changing the dose or dosing schedule can help get more vaccines to the public faster. However, making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health.
“We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine.”
In a joint statement Pfizer and BioNTech warned there was no data to demonstrate that protection after the first dose is sustained after 21 days. “The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design,” said the companies.
The Oxford-AstraZeneca vaccine trial did include difference spacing between doses and showed longer gaps (two to three months) yielded a greater immune response. The combined trial results published in the Lancet showed that vaccine efficacy 14 days after a second dose was higher in the group that had more than six weeks between the two doses (65.4%) than in the group that had less than six weeks between doses (53.4%).
Andrew Pollard, head of the Oxford Vaccine Group and chief trial investigator vaccine told the BMJ that extending the gap between doses made sense.
“Generally, a longer gap between vaccine doses leads to a better immune response, with the second dose causing a better boost. (With HPV vaccine for girls, for example, the gap is a year and gives better responses than a one-month gap.) From the Oxford vaccine trials, there is 70% protection after the first dose up to the second dose, and the immune response was about three times greater after the second dose when the second dose was delayed, comparing second dose after four weeks versus second dose after two-three months.”
Akiko Iwasaki, professor of immunobiology at Yale Medical school also tweeted support for the changes, stating the new SARS-CoV-2 variant as the deciding factor.
“I am still a proponent of two-dose vaccine but given the urgency, we can delay the seconnd dose until more vaccines become available. I know many others have been saying this all along, but it was the B.1.1.7 variant transmission rate that did it for me,” said Iwasaki.
David Grainger, chief scientific advisor at life sciences investment firm Medicix, also expressed confidence in the strategy, referring to modelling by the University of Toronto that predicts increasing the number of people protected, by limiting individuals to a single dose, reduces severe COVID events (ICU stays and death) by between 30-40% over a 6-month period. This could amount to over 20,000 lives saved.
“The vaccine only must be 50% effective in two people to reduce the overall risk of infection that is achieved with 95% protection in one person,” said Grainger. “If I protect 10,000 people out of a population of 20,000 with 1% risk of infection at 95% efficacy, I get five cases from the protected subgroup and 95 cases in the unprotected subgroup for a total of 100 infections; if I protect all 20,000 people with 50% efficacy, again I get 100 infections. The existing data strongly suggests that a single dose will deliver at least 50% protection for at least a few months.”
He added that during the pandemic, decisions often needed to be made in the absence of proper data. “It teaches us that we cannot just ‘follow the science’ because that pathway is way too conservative (at least if that means only do things for which there is clear, direct evidence).
“This is why we should have scientific advisors, but not rely on scientists to make decisions. It is why scientists rarely make good investors or businessmen – too many decisions need to be made in the absence of much information.”
The post Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy appeared first on .
KHN chief Washington correspondent Julie Rovner discussed covid’s impact on current politics with WAMU’s “1A” on Dec. 31.
KHN Midwest correspondent Lauren Weber discussed covid in a 2020 news roundup on WAMU’s “1A” on Dec. 31.
KHN senior correspondent Phil Galewitz discussed deep cleaning the White House before the Bidens arrive with Newsy on Dec. 23.
- Click here to watch Galewitz on Newsy
- Read Galewitz’s “As Biden Gets Sworn In, White House Will Get Scrubbed Down”
KHN Midwest correspondent Cara Anthony discussed what it’s like to be a reporter during a pandemic with St. Louis Public Radio’s “We Live Here.”
USE OUR CONTENT
This story can be republished for free (details).
How can pharma improve the patient-centricity of its trials during COVID-19 and beyond? Experts from across the sector give their thoughts on the key approaches and technologies that are driving patient engagement forward.
With COVID-19 presenting new barriers to running and recruiting for clinical trials, making studies patient-centric is more important now than ever before.
According to one analysis, conducted by Global Data, approximately 67% of trial disruptions during the early stages of the pandemic were due to the suspension of enrolment, followed by the delayed start of planned trials at 18.4% and slow enrolment at 14.4%.
Ensuring that trials are easy to access and don’t overly burden the patient is essential amidst these potential disruptions – but a truly patient-centric trial has benefits beyond enrolment.
Trials that are engaging and easy to partake in can lead to higher adherence, higher satisfaction, improved data quality and overall performance, and can even give participants a more positive view of the sponsor company in terms of their commitment to bring new treatments to patients.
• Read the full article in pharmaphorum’s Deep Dive digital magazine
The post True patient-focused research through decentralised and hybrid trials appeared first on .
Washtenaw is a county of nearly 350,000 residents who live in and around the city of Ann Arbor, about 45 minutes from Detroit. Until mid-October, a county team of 15 contact tracers was managing the workload. But by Thanksgiving, more than 1,000 residents were testing positive for the coronavirus every week, and the tracers could not keep pace.
In Washtenaw County, the process starts with people called case investigators, who receive lab reports of positive coronavirus tests. Their job is to call anyone who has tested positive, tell them they need to isolate and ask them for the names of people with whom they have had close contact. After creating a list of potentially exposed “contacts,” investigators pass it to a new team to start the actual contact tracing. As the number of positive cases builds, the number of calls tracers must make swells.
But in recent weeks, it’s not just the number of positive cases that has increased, overwhelming the capacity of case investigators — so has the number of contacts that each infected person has, said contact tracer Madeline Bacolor.
“There’s just so many more people that are gathering and that are exposed,” she said. “It used to be, we had a case, and maybe that person had seen two people, and now it’s a whole classroom full of day care students or a whole workplace.”
The work to keep people who have been exposed to the virus away from people who have not is crucial, said public health professor Angela Beck, because it breaks viral transmission chains and prevents the virus from spreading unchecked through a community.
Beck teaches at the University of Michigan and runs the campus program for tracing coronavirus exposures among students.
When you’re trying to contain an infectious disease, she said, running out of contact tracers is “not a situation that you want to be in.”
But it’s happening now in health departments in Michigan and around the U.S. where contact tracing workforces have grown, but not fast enough to keep pace with the pandemic’s spread.
As a result, health departments are asking some residents with covid to reach out to their contacts on their own.
Trying ‘a Compromised Strategy’
Once billed as one of the fundamental tools for stemming the spread of the virus, contact tracing has fallen apart in many regions of the country. It’s a systematic breakdown that Lawrence Gostin, a professor of global health law at Georgetown University, said hasn’t happened since the spread and stigma of HIV and AIDS in the 1980s and ’90s.
In Michigan’s rural Upper Peninsula, a public health district spanning five counties warned residents that its tracers were overwhelmed and that they might not receive a call at all, despite testing positive. Health workers would need to focus their efforts on residents 65 and older, teens and children attending school in person, and people living in group settings.
In Michigan’s southwestern corner, contact tracers in Van Buren and Cass counties can no longer keep up with their calls. It’s the same situation in Berrien County: “If you test positive, take action immediately by isolating and notifying close contacts,” the county health officer urged residents in a press release.
Within many health departments, the shortage of contact tracers has been exacerbated by the communications challenge of relaying a recent change in quarantine guidance from the Centers for Disease Control and Prevention — it reduced the quarantine period from 14 days to 10 for some individuals exposed to the virus.
The idea behind the change was that the risk of transmission after 10 days of quarantine was low, and shorter quarantine periods might increase people’s willingness to comply with the orders. But the shift also meant that contact tracers had to spend time learning and explaining the new procedures just when caseloads were exploding.
“It makes things more confusing,” said Bacolor, the contact tracer in Washtenaw County. “People might be hearing something different from their job or school than they are from the health department.”
Asking infected people, some of whom might be sick, to call their own friends and families — in effect, conduct their own contact-tracing operation — is far from ideal, public health experts said.
“It is a last-resort tool,” said Beck, the University of Michigan professor. “It is the best that we can do in the situation that we’re in, but it’s a compromised strategy.”
Contact tracing is more than just alerting people to a potential exposure so they can quarantine. Part of the process is to conduct carefully structured interviews with those exposed, to determine if they’ve developed symptoms of covid-19. If so, contacts of those people also need to be traced and told to quarantine, to prevent the virus from proliferating through successive chains of people in the community.
Trained contact tracers also often ask valuable questions to learn more about how the virus was transmitted from person to person so that local health officials can piece together an understanding about which settings and activities seem particularly likely to promote spread — in-person choir rehearsals and crowded bars, for example — and which are unlikely to generate outbreaks.
Contact tracing is a key part of a tried-and-true strategy known as “test, trace and isolate.” Public health professor Beck said the strategy has been used all over the world and it works — when there are enough people and enough time to do it properly.
And she said effective contact tracing can help mitigate the economic pain of a pandemic because it means that only people with known exposures to the virus must stay away from workplaces and school and refrain from other activities.
But success requires significant investment in public health infrastructure, something that Beck and other researchers said has been lacking for decades in the U.S.
This story is part of a partnership that includes NPR and KHN.
USE OUR CONTENT
This story can be republished for free (details).
Nowhere on the list of prioritized recipients are public officials’ spouses.
Yet the first ladies of Kentucky and West Virginia; Republican Vice President Mike Pence’s wife, Karen Pence; Democratic President-elect Joe Biden’s wife, Jill Biden; and Vice President-elect Kamala Harris’ husband, Doug Emhoff, were among the first Americans to get the potentially lifesaving shots.
Kentucky also vaccinated six former governors and four former first ladies, including current Democratic Gov. Andy Beshear’s parents.
The early vaccinations of political spouses spurred outrage on social media, with several Twitter users saying they should not be able to “jump the line” ahead of doctors, nurses and older people.
In most of the 29 states that responded to KHN inquiries of all 50 governors’ offices, top elected officials said they — and their spouses — will be vaccinated but have chosen to wait their turn behind more vulnerable constituents. Some Congress members from both parties said much the same when they refused early doses offered in the name of keeping the government running. Those weren’t offered to their spouses.
Governors who got the shots along with their spouses, and the vice president’s office, said they wanted to set an example for residents, build trust, bridge ideological divides and show that the vaccine is safe and effective.
But that’s a rationale some critics don’t buy.
“It looks more like cutting in line than it does securing trust. The politicians can get the hospitals to give it to them under this illusion of building trust. But it’s a façade,” said Arthur Caplan, a bioethics professor and founding head of the medical ethics division at New York University Grossman School of Medicine. “People might say: ‘Yup, typical rich people. They can’t be trusted.’ This undermines what they set out to do.”
Besides, Caplan said, the public doesn’t trust politicians all that much anyway, so inoculating celebrities, religious leaders or sports figures would likely do more to boost confidence in the vaccine. Rock ’n’ roll king Elvis Presley famously got the polio vaccine in 1956 to help win over those who were skeptical; the actions of governors’ wives from that period are less remembered.
Dr. José Romero, chairperson of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, said in an email to KHN that while his group provides an outline for distributing limited vaccine doses, “jurisdictions have the flexibility to do what’s appropriate for their population.” Kentucky and Texas officials pointed out that CDC Director Dr. Robert Redfield encouraged governors to publicly get the vaccine.
No one mentioned medical reasons for their spouses to get vaccines; hospitals are generally not vaccinating the spouses of medical professionals who have gotten the shot. (It’s unclear whether vaccinated people can still spread the virus, so it’s possible that a vaccinated person could pass the virus to their spouse or have to quarantine if an unvaccinated spouse were to get covid.)
The office of West Virginia’s governor, Republican Jim Justice, released pictures of him, his wife, Cathy Justice, and other officials receiving shots. He also showed his own vaccination on YouTube.
Beshear’s office in Kentucky also released photos of him getting the vaccine in December on the same day as his wife, Britainy Beshear, and other state officials.
“There is no question that there is vaccine hesitancy out there,” Beshear said at a coronavirus briefing on Monday, the day former Kentucky governors and their spouses were vaccinated. He alluded to a future program involving faith leaders and others. “Validators are incredibly important to building that confidence.”
His father, Democratic former Gov. Steve Beshear, posted photos of his vaccination on his Facebook page, saying that he and his wife, Jane Beshear, along with other former Kentucky governors of both parties and their spouses, stepped up partly to show residents the vaccine is safe and encourage them to get it when it’s available to them.
Kentucky is currently in the first stage of vaccine distribution, which targets health care workers and residents of long-term care and assisted living facilities. Fewer than 15,000 of the 58,500 doses received for long-term care had been given out when the former governors and their spouses were vaccinated.
Tres Watson, a former communications director for the Republican Party of Kentucky who founded a political consulting firm, was skeptical about the intentions behind the event. He said it seemed to be a public relations effort created so the governor could vaccinate his parents.
“I understand the continuity of government, but first ladies have no part in the continuity of government,” he said. “You need to stick with the priorities. Once you start making exceptions, that’s when you run into problems.”
Officials representing the Biden-Harris transition team and three other states where governors got vaccinated — Republican-led West Virginia and Texas, and Democratic-led Kansas — either didn’t respond to KHN or didn’t answer questions about spouses. Alabama’s Republican governor, Kay Ivey, got the vaccine and is divorced.
Politicians in other states have taken the opposite tack.
In Arkansas, Republican Gov. Asa Hutchinson is focused on ensuring high-priority groups such as health care workers, long-term care staffers and residents are vaccinated, said spokesperson LaConda Watson. “He and his wife will receive the vaccination when it’s their turn,” she said.
In Missouri, Kelli Jones, communications director for Republican Gov. Mike Parson, said in an email that he and the first lady fully intend to get the vaccine. Like governors from Colorado, Nevada and elsewhere, they’ve both recovered from covid-19, Jones said, and will “wait until their age group is eligible” under the state plan. Doctors recommend vaccinations even for people who have already had covid.
Cissy Sanders, 52, an events manager who lives in Austin, Texas, said she understands why lawmakers would need to get the vaccine. Her own governor, Republican Greg Abbott, received it on live television to instill confidence, said his press secretary, Renae Eze, who wouldn’t address whether Abbott’s wife was vaccinated.
But Sanders said politicians’ spouses should not be vaccinated before nursing home residents like her 71-year-old mom. Sanders’ mother received the vaccine in late December — after some public officials’ spouses — but she said far too many nursing home residents across America are still waiting.
“Why is a non-high-risk group — i.e., these spouses — going before the most high-risk group? Who makes these decisions? Who thinks this is a good, responsible, safe decision to make?” she said. “Political spouses have not been at ground zero for the virus. Nursing home residents have been.”
KHN Montana correspondent Katheryn Houghton, California Healthline correspondent Angela Hart and KHN senior correspondents Markian Hawryluk and JoNel Aleccia contributed to this report.
USE OUR CONTENT
This story can be republished for free (details).
- Bayer to support the development, supply and key territory operations of CureVac´s COVID-19 vaccine candidate, CVnCoV and will contribute its expertise and established infrastructure in numerous area
- Curevac will be the MAH for the product while Bayer will support CureVac with country operations within the EU and additional markets. Additionally, Bayer has an option to MAH outside the EU
- The companies plan to combine their strengths for CureVac to be in a position to supply hundreds of millions of CVnCoV doses across the globe
Click here to read full press release/ article | Ref: Bayer | Image: GMPNews
The post Bayer Collaborates with CureVac for CVnCoV Against COVID-19 first appeared on PharmaShots.
Can’t see the audio player? Click here to listen on SoundCloud.
Surprise Democratic victories in Georgia’s two runoff elections this week will give Democrats control of the Senate, which means they will be in charge of both houses of Congress and the White House for the first time since 2010. Although the narrow majorities in the House and Senate will likely not allow Democrats to pass major expansions to health programs, it will make it easier to do things such as pass fixes for the Affordable Care Act.
Meanwhile, the speedy development and approval of vaccines to protect against covid-19 is being squandered by the lack of a national strategy to get those vaccines into people’s arms. Straightening out and speeding up vaccinations will be a major priority for the incoming administration of President-elect Joe Biden.
This week’s panelists are Julie Rovner of Kaiser Health News, Anna Edney of Bloomberg News, Alice Miranda Ollstein of Politico and Mary Ellen McIntire of CQ Roll Call.
Among the takeaways from this week’s podcast:
- The Georgia election results will make it easier for some of Biden’s Cabinet picks to be confirmed, including Xavier Becerra, his choice to head the Department of Health and Human Services.
- Among the ACA fixes that congressional Democrats may seek is a restoration of a small penalty for people who do not have health coverage. That could negate the case before the Supreme Court now that was brought by Republican state officials.
- One strategic error in the covid vaccine distribution efforts was that the release of the vaccine was not coupled with a major messaging campaign to explain what the vaccine does and dispel fears about it.
- Late last month, a federal court blocked the Trump administration from implementing a plan to tie what Medicare pays for some drugs to the prices in other countries. It’s not clear if the Biden administration will continue the legal fight to keep the program, but the president-elect has suggested he is more interested in bringing down drug prices by negotiating with manufacturers.
- The Trump administration has sued retail giant Walmart, alleging it unlawfully dispensed opioids from its pharmacies.
Also, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:
Julie Rovner: The New York Times’ “One Hospital System Sued 2,500 Patients After Pandemic Hit,” by Brian M. Rosenthal
Alice Miranda Ollstein: Politico’s “Congress Using COVID Test That FDA Warns May Be Faulty,” by David Lim and Sarah Ferris
Mary Ellen McIntire: Bloomberg News’ “The World’s Most Loathed Industry Gave Us a Vaccine in Record Time,” by Drew Armstrong
Anna Edney: STAT News’ “How It Started: A Q&A With Helen Branswell, One Year After Covid-19 Became a Full-Time Job,” by Jason Ukman
To hear all our podcasts, click here.
USE OUR CONTENT
This story can be republished for free (details).
On November 19th, six teams competed in two virtual pitch events for the finals of two Robert Wood Johnson Foundation Innovation Challenges, one for Emergency Response for the General Public and the other for Emergency Response for the Health Care System.
The teams – binformed | covidata, CovidSMS, and Fresh EBT by Propel for the General Public Challenge and Path Check, Qventus, and Tiatros, Inc., for the Health Care System Challenge – presented in front of expert judging panels, who evaluated the entries on impact, UX/UI, innovation/creativity, scalability and strength of presentation. (You can see the demos for all teams on yesterday’s post here)
binformed | covidata and CovidSMS tied for first place in the RWJF Emergency Response for the General Public Challenge and were each awarded $17,500.
Meanwhile, Qventus was declared the winner of the RWJF Emergency Response for the Health Care System Innovation Challenge and received $25,000.
After they had a chance to catch their breath and enjoy their wins, Catalyst caught back up with the three winning teams – hear the winners’ reflections below:
Elizabeth Brown is a Program Manager at Catalyst @ Health 2.0
Algunos llegan tan enfermos que van directo a cuidados intensivos. Muchos no sobreviven.
“Vivimos una pesadilla constante”, dijo Prendkowski mientras trataba a pacientes con coronavirus en el Hospital Mount Sinai, fundado a principios del siglo XX para atender a los inmigrantes más pobres. “Ojalá salgamos pronto de esto”.
La enfermera cree que algunas muertes, y mucho sufrimiento, podrían haberse evitado si estas personas hubieran tenido un tratamiento regular para todo tipo de condiciones crónicas —asma, diabetes, enfermedades del corazón— que pueden empeorar COVID-19.
Y ahora se siente esperanzada.
En medio del brote del mortal virus que ha afectado de manera desproporcionada a las comunidades hispanas, Illinois se convirtió recientemente en el primer estado de la nación en extender el seguro médico público a todos los adultos mayores no ciudadanos de bajos ingresos, incluso si son indocumentados.
Defensores de los inmigrantes esperan que inspire a otros estados a hacer lo mismo. De hecho, legisladores demócratas de California están presionando para expandir su Medicaid a todos los inmigrantes indocumentados del estado.
“Hacer esto durante la pandemia muestra nuestro compromiso con la expansión y ampliación del acceso a la atención de salud. Es un gran primer paso”, señaló Graciela Guzmán, directora de campaña de Healthy Illinois, que promueve la cobertura universal en el estado.
Muchos inmigrantes indocumentados sin cobertura de salud no van al médico. Ese fue el caso de Victoria Hernández, una limpiadora de casas de 68 años que vive en West Chicago, Illinois. La mujer, nativa de la Ciudad de México dijo que, cuando no tenía seguro, simplemente no iba al médico.
Soportaba cualquier dolencia hasta que encontró un programa de caridad que la ayudó a tratar su prediabetes. Dijo que tiene la intención de inscribirse en el nuevo plan estatal una vez que tenga más información.
“Estoy muy agradecida por el nuevo programa”, explicó a través de un traductor que trabaja para DuPage Health Coalition, una organización sin fines de lucro que coordina la atención de caridad para personas sin seguro médico como Hernández en el condado de DuPage, el segundo más poblado del estado. “Sé que ayudará a mucha gente como yo. Sé que tendrá buenos resultados, muy, muy buenos resultados”.
Primero, Healthy Illinois intentó ampliar los beneficios de Medicaid a todos los inmigrantes de bajos ingresos, pero los legisladores decidieron empezar con un programa más pequeño, que cubre a adultos mayores de 65 años o más que son indocumentados, o que han sido residentes permanentes, tienen tarjeta verde, por menos de cinco años (este grupo no califica para seguro de salud auspiciado por el gobierno).
Los participantes deben tener ingresos que estén en o por debajo del nivel de pobreza federal, que es de $12,670 para un individuo o $17,240 para una pareja. Cubre servicios como visitas al hospital y al médico, medicamentos recetados, y atención dental y oftalmológica (aunque no estancias en centros de enfermería), sin costo para el paciente.
La nueva norma continúa la tendencia de expandir la cobertura de salud del gobierno a los inmigrantes sin papeles.
El año pasado, California fue el primero en ofrecer cobertura pública a los adultos indocumentados, cuando amplió la elegibilidad para su programa Medi-Cal a todos los residentes de bajos ingresos menores de 26 años.
Según la ley federal, las personas indocumentadas generalmente no son elegibles para Medicare, Medicaid que no es de emergencia y el mercado de seguros de salud de la Ley de Cuidado de Salud a Bajo Precio (ACA). Los estados que ofrecen cobertura a esta población lo hacen usando sólo fondos estatales.
Se estima que en Illinois viven 3,986 adultos mayores indocumentados, según un estudio del Centro Médico de la Universidad de Rush y el grupo de demógrafos de Chicago Rob Paral & Associates; y se espera que el número aumente a 55,144 para 2030. El informe también encontró que el 16% de los inmigrantes de Illinois de 55 años o más viven en la situación de pobreza, en comparación con el 11% de la población nacida en el país.
Dado que la administración saliente de Trump ha promovido duras medidas migratorias, sectores del activismo pro inmigrante temen que haya miedo a inscribirse en el nuevo programa porque podría afectar la capacidad de obtener la residencia o la ciudadanía en el fututo, y trabajan para asegurarles que no lo hará.
“Illinois cuenta con un legado de ser un estado que acepta al recién llegado y de proteger la privacidad de los inmigrantes”, señaló Andrea Kovach, abogada que trabaja en equidad en la salud en el Shriver Center for Poverty Law en Chicago.
Se espera que la normativa cubra inicialmente de 4,200 a 4,600 inmigrantes mayores, a un costo aproximado de entre $46 millones a $50 millones al año, según John Hoffman, vocero del Departamento de Salud y Servicios Familiares de Illinois.
Algunos representantes estatales republicanos criticaron la expansión de la cobertura, diciendo que era imprudente hacerlo en un momento en que las finanzas de Illinois sufren por la pandemia. En una declaración condenando el presupuesto estatal de este año, el Partido Republicano de Illinois lo denominó “atención de la salud gratuito para los inmigrantes ilegales”.
Pero los defensores de la nueva política sostienen que muchos inmigrantes sin papeles pagan impuestos sin ser elegibles para programas como Medicare y Medicaid, y que gastar por adelantado en cuidados preventivos ahorra dinero, a largo plazo, al reducir el número de personas que esperan para buscar tratamiento hasta que es una emergencia.
Para Delia Ramírez, representante estatal de Illinois, ampliar la cobertura de salud a todos los adultos mayores de bajos ingresos es personal. A la demócrata de Chicago la inspira su tío, un inmigrante de 64 años que no tiene seguro.
Dijo que intentó que la legislación cubriera a las personas de 55 años o más, ya que la gran mayoría de los indocumentados no son personas mayores (señaló que muchos de los inmigrantes mayores —2,7 millones, según estimaciones del gobierno— obtuvieron el estatus legal con la ley de amnistía federal de 1986).
Un mayor número de inmigrantes más jóvenes también pueden estar sin seguro. En los Centros de Salud Esperanza, uno de los mayores proveedores de atención médica para inmigrantes de Chicago, el 31% de los pacientes de 65 años o más carece de cobertura, en comparación con el 47% de los de 60 a 64 años, según Jeffey McInnes, que supervisa el acceso de los pacientes a las clínicas.
Ramírez dijo que su tío la llamó después de ver las noticias sobre la nueva legislación en la televisión en español. Contó que su tío ha vivido en el país por cuatro décadas y ha trabajado para que sus cuatro hijos fueran a la universidad. También padece asma, diabetes e hipertensión, lo que lo hace de alto riesgo para COVID-19.
“Yo le dije: ‘Tío, todavía no. Pero cuando cumplas 65 años, finalmente tendrás atención médica, si es que aún no hemos conseguido legalizarte”, recordó Ramírez, emocionada, durante una reciente entrevista telefónica.
“Así que es un recordatorio para mí de que, en primer lugar, fue una gran victoria para nosotros y ha significado la vida o una segunda oportunidad de vida para muchas personas”, dijo. “Pero también significa que todavía tenemos un largo camino por recorrer para hacer de la atención de salud un verdadero derecho humano en el estado, y en la nación”.
USE OUR CONTENT
This story can be republished for free (details).
The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules.
With the UK reeling from one of the worst outbreaks of the disease, it’s a worrying situation for one of the countries worst hit by the pandemic that is relying on vaccines to bring the virus under control.
The UK is in a national lockdown that could last into March, with more than 62,000 new cases and 1,000 coronavirus-related deaths recorded yesterday as a more transmissible strain threatens to overwhelm the country’s health service.
As things stand, the two rival mRNA-based vaccines from Pfizer/BioNTech and Moderna are now approved for use in the EU.
Meanwhile in the UK, the Pfizer/BioNTech and AstraZeneca shots have been quickly approved.
The UK government has an order for just 7 million shots of the Moderna vaccine covering just half a percent of the population, while the European Commission has secured 160 million doses, enough to cover around 18% of the population.
US-based Moderna said that first deliveries of the vaccine in Europe will begin next week.
Moderna’s vaccine is arguably the most effective approved so far at around 95%, while AstraZeneca’s rival that has been swiftly approved in the UK ahead of Europe works in around 62% of cases when given its recommend dose.
The Pfizer/BioNTech seems to be of comparable efficiency to the Moderna shot, and is being rolled out across the UK along with the AZ vaccine.
There is evidence to suggest the AZ vaccine’s efficacy could be improved to 90% by giving a half-dose to start with, but UK regulators have not been given sufficient evidence to approve this formulation.
After a rolling review began of Moderna’s vaccine late last year, the European Commission has issued a conditional marketing authorisation the day after it was backed by regulators from the CHMP scientific committee.
Moderna has said it is in talks with the UK regulator over approval, where European Commission decisions on medicines no longer automatically apply because of Brexit.
Under Brexit transition arrangements the Medicines and Healthcare products Regulatory Authority (MHRA) will continue to adopt decisions by the European Commission on medicines.
In usual circumstances companies are required to submit an identical filing request to the MHRA after a CHMP positive opinion
The UK regulator would then follow the decision of the European Commission, which nearly always rubber-stamps the CHMP’s decision within a few weeks.
But on this occasion the process has not been possible because of the accelerated timelines for vaccine approval because of the pandemic.
Questioned by pharmaphorum, the MHRA was unable to comment on arrangements for the Moderna vaccine at the time of writing.
However Moderna said separately that it is in talks with the MHRA to get the vaccine approved.
The post UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine appeared first on .
Shortly after launching large-scale trials of its COVID-19 vaccine candidate, CureVac has the partner it will need to roll the shot out at scale if it works as hoped.
Bayer has joined forces with the German biotech to support the development and supply of CVnCoV, an mRNA candidate using a similar technology to the Pfizer/BioNTech and Moderna jabs, with the drugmaker saying it will help CureVac produce “several hundred million doses”.
CureVac has been working steadily on CVnCoV over the last few months as the spotlight was trained on candidates originated by BioNTech, Moderna and AstraZeneca, which were a little further ahead in development, but began its own phase 2b/3 study in mid-December.
It’s hoping for interim results from that in the first quarter of this year, which if positive could be followed by rolling regulatory submissions and – potentially at least – emergency approvals sometime towards the late spring/early summer.
The trial is assessing the safety and efficacy of CVnCoV in adults of various ages and once fully enrolled will include more than 35,000 participants in Europe and Latin America.
It aims to demonstrate the efficacy of CVnCoV in preventing first cases of confirmed COVID-19 of any severity, as well as preventing moderate to severe disease, in participants who have never been infected with the SARS-CoV-2 virus.
The European Commission – which has just approved the Moderna vaccine and previously gave a green light to the Pfizer/BioNTech shot – already has an order in for 405 million doses of the CureVac vaccine. It gave CureVac €75 million in funding to develop CVnCoV last July, adding to around €100 million provided by the German government in 2020.
The biotech would likely struggle to supply without the help of its new big pharma partner, although it has been expanding its production capacity in the last few weeks with the help of contract manufacturers like Wacker and Fareva.
Bayer said it will contribute in areas like clinical operations, regulatory affairs, pharmacovigilance, medical information, and supply chain performance to help get the vaccine to the public as quickly as possible.
“We are highly committed to making our capabilities and networks available to help end this pandemic,” said Stefan Oelrich, president of the German group’s pharma division.
Bayer is providing assistance to CureVac primarily in the EU and some other markets, where the German biotech will be the marketing authorisation holder, but has an option to seek approval of CVnCoV on its own account in countries outside Europe.
CureVac has previously said however that it does not intend to introduce its vaccine in the US – at least while the pandemic is ongoing – because the government there has already ordered enough supplies of rival jabs to immunise the entire population.
At last count, there are more than 60 coronavirus vaccines at in clinical development around the world, with another 170 in preclinical testing, according to the World Health Organization (WHO).
The post Bayer joins the COVID-19 vaccine push, backing CureVac shot appeared first on .
Research from a large-scale survey of 1000+ senior pharma professionals has highlighted the divide between digitally adept companies and those that have been slow to adopt technologies. We look at how the customer experience is changing due to COVID-19.
Historically, pharma has lagged behind other industries in adopting digital solutions, but with COVID-19 catapulting the sector, and healthcare in general, into a new digital era, the landscape is changing significantly and rapidly. What will this transformation mean for pharma’s customer experience?
In an April survey conducted by Reuters and Omnipresence, 1,363 senior professionals mostly working in pharma (82.8%) in the EMEA region (73%) and biotech, medtech/device or consumer health companies reported on how life sciences organisations were adapting to the ‘new normal’.
With severe restrictions on face-to-face engagements during the pandemic, digital engagement has been one of the few ways companies have been able to connect with customers. Findings from the report highlighted an urgent need for investments in customer relationship management (CRM) capabilities.
A unified approach
According to Sanjay Virmani, CEO of Omnipresence, a key struggle for pharma companies comes from the lack of a common data model, preventing them from having a connected and holistic view of the individuals they’re trying to engage with.
“When an organisation looks at an HCP or customer, are they a marketing customer, a medical affairs customer, a sales customer?”
“If different departments are not coordinated, how can the customer get all the information they need with the proper context? And if the company does not provide that seamless experience, the customer has to glue it together themself or not get it” – Sanjay Virmani
“It is not as if companies have not invested in the infrastructure and are not generating this data. The problem may be that there is no unification that is so essential to going in that agile, omnichannel direction.”
Unified platforms that can pull in data from multiple digital channels can help create a better customer experience according to Virmani. “There is a need to reinvest in the technology stack to be able to drive unification, but there is also a need to reinvent the cultural stack so that different departments are working in a coordinated manner,” he said.
“If different departments are not coordinated, how can the customer get all the information they need with the proper context? And if the company does not provide that seamless experience, the customer has to glue it together themself or not get it.”
In the report, 70% of respondents said they needed better ability to surface customer insights from various channels into digital workflows/CRM. 75% said they needed a more agile method to ingest and consolidate insights across channels and 65% said their CRM needed to improve the method and quality of data collection.
Pharma is also failing to utilise engagement tools, such as chatbots, even though many sectors are using them on some level. According to a report by Juniper Research, the banking sector is expected to automate up to 90% of customer interactions using chatbots by 2022.
“About 40% [of respondents] were not doing that at scale across multiple countries, regions, languages, and products,” said Virmani.
Hybrid strategies that enable companies to have the flexibility to shift between virtual and in-person engagement are likely to be where the industry is heading, Herman De Prins, chief information officer at UCB, explained, adding: “I don’t think we will have complete virtual HCP engagement post-pandemic. We already saw this in the first few months of the pandemic; there was an immediate move towards complete virtual HCP engagement, but once the pandemic restrictions were slightly loosened, we saw face-to-face coming back relatively strong. We do believe that remote engagements will continue — but they will be a hybrid engagement and not a purely virtual one.”
This survey also showed how companies were putting specific strategies in place to improve HCP engagement through modern digital channels, that were considered “non-traditional” pre-pandemic. 73.6% of respondents said they expected the use of social media to engage with HCPs to increase over the next 12 months. However, the transition to digital commercial operations has proved challenging for some companies with 32.3% of respondents saying their organisation did not have the commercial data and analytics capabilities to support digitisation of sales and marketing operations and 28.6% stating their organisation did not have the right technology/platform/channel capabilities to support the digitisation of sales and marketing including virtual sales capabilities.
“CRM is only a minor part in the broader omnichannel approach. Changing only the CRM would achieve nothing but spend more money. What is truly needed is a deep change in the analytical and go-to market approaches and optimising the new channels” – Florent Edouard
Florent Edouard, SVP, global head of commercial excellence at Grünenthal Group, commented: “The 60% or so who think they are ready for complete digitisation of sales and marketing operations say so because they have not truly tried it.
“This is probably the most challenging part of the digital transformation, as we need to acquire skills such as advanced analytics that we currently do not have, turn our customer model fully around, and implement tools that are able to create sophisticated AI-powered models that can manipulate billions of data points. Very few companies are equipped to do that in their commercial entities.”
Time for change
Commercial teams should now address the gaps they have in data and analytics and accelerate the adoption of omnichannel capabilities. While CRM was traditionally built for a time where there were only one or two channels, it is now becoming a thing of the past.
Omnichannel approaches that allow bi-directional engagement on all modern channels provide a seamless and individualised customer experience that will soon become the ‘better normal’. Key benefits could be medical chatbots answering simple dosing questions, HCPs triggering inbound virtual meeting requests and ensuring compliant social media engagement from field teams to HCPs.
But what exactly does this mean for life sciences companies? “This means we need much better CRM capabilities than pre-pandemic. That does not mean these capabilities are not available. It just means they have not been exploited” said De Prins.
Organisations have started to recognise the urgency, with 79.7% of survey respondents stating the pandemic will influence priorities towards investments in customer experience.
“CRM is only a minor part in the broader omnichannel approach,” said Edouard. “Changing only the CRM would achieve nothing but spend more money. What is truly needed is a deep change in the analytical and go-to market approaches and optimising the new channels.”
Virmani agreed that the pandemic has made the need for better insights and analytics from CRMs and other CX systems much clearer and more urgent. “There will be a greater emphasis on the connected customer journey. Many companies are already thinking about customer experience as a competitive edge.”
Maximising the best management of customer experiences is one of the essential strategies that pharma companies can take to stand out from the competition. Indeed, companies that will triumph in the post COVID-19 world are the ones that continue to allocate resources, execute omnichannel development, remove silos and move towards a more unified and agile digital approach.
As the pandemic continues to accelerate the pace of digital change around healthcare, organisations need to grasp the opportunities this shift presents to make far-reaching improvements to their customer experience.
Check out the full report: COVID-19: Accelerating Digital Transformation in Life Sciences
Download the executive summary: COVID-19: A Pulse of the Life Sciences Industry
Omnipresence is a unified and intelligent customer experience management platform (CXM) for healthcare and life sciences organisations with CRM, omnichannel engagement, advanced analytics, and AI capabilities in a single platform.
The post 2021 Outlook: The future for life sciences customer experience appeared first on .
“We’re in a bad dream all the time,” she said during a recent day treating coronavirus patients at Mount Sinai Hospital, which was founded in the early 20th century to care for the city’s poorest immigrants. “I can’t wait to wake up from this.”
Prendkowski believes some of the death and suffering could have been avoided if more of these people had regular treatment for the types of chronic conditions — asthma, diabetes, heart disease — that can worsen covid. She now sees a new reason for hope.
Amid a deadly virus outbreak that has disproportionately stricken Latino communities, Illinois recently became the first state to provide public health insurance to all low-income noncitizen seniors, even if they’re in the country illegally. Advocates for immigrants expect it will inspire other states to do the same, building on efforts to cover undocumented children and young adults. Currently, Democratic legislators in California are pushing to expand coverage to all low-income undocumented immigrants there.
“The fact that we’re going to do this during the pandemic really shows our commitment to expansion and broadening health care access. It’s an amazing first step in the door,” said Graciela Guzmán, campaign director for Healthy Illinois, a group that advocates for universal coverage.
Undocumented immigrants without health insurance often skip care. That was the case for Victoria Hernandez, 68, a house cleaner who lives in West Chicago, a suburb. The Mexico City native said she had avoided going to the doctor because she didn’t have coverage. Eventually, she found a charity program to help her get treatment, including for her prediabetes. She said she intends to enroll in the new state plan.
“I’m very thankful for the new program,” she said through a translator who works for the DuPage Health Coalition, a nonprofit that coordinates charity care for the uninsured in DuPage County, the state’s second-most populous. “I know it will help a lot of people like me.”
Healthy Illinois pushed state lawmakers to offer health benefits to all low-income immigrants. But the legislature opted instead for a smaller program that covers people 65 and older who are undocumented or have been legal permanent residents, also known as green card holders, for less than five years. (These groups don’t typically qualify for government health insurance.) Participants must have an income at or below the federal poverty level, which is $12,670 for an individual or $17,240 for a couple. It covers services like hospital and doctor visits, prescription drugs, and dental and vision care (though not stays in nursing facilities), at no cost to the patient.
The new policy continues a trend of expanding government health coverage to undocumented immigrants.
Illinois was the first state to cover children’s care — a handful of states and the District of Columbia have since followed suit — and organ transplants for unauthorized immigrants. In 2019, California became the first to offer public coverage to adults in the country illegally when it opened eligibility for its Medi-Cal program to all low-income residents under age 26.
Under federal law, undocumented people are generally not eligible for Medicare, nonemergency Medicaid and the Affordable Care Act’s health insurance marketplace. The states that do cover this population get around that by using only state funds.
An estimated 3,986 undocumented seniors live in Illinois, according to a study by Rush University Medical Center and the Chicago demographer group Rob Paral & Associates — but that number is expected to grow to 55,144 by 2030. The report also found that 16% of Illinois immigrants 55 or older live in poverty, compared with 11% of the native-born population.
Given the outgoing Trump administration’s crackdown on immigration, some advocates worry that people will be afraid to enroll in the insurance because it could affect their ability to obtain residency or citizenship. Andrea Kovach, senior attorney for health care justice at the Shriver Center on Poverty Law in Chicago, said she and others are working to assure immigrants they don’t need to worry. Because the new program is state-funded, federal guidance suggests it is not subject to the “public charge” rule designed to keep out immigrants who might end up on public assistance.
“Illinois has a legacy of being a very welcoming state and protecting immigrants’ privacy,” Kovach said.
The Illinois policy is initially expected to cover 4,200 to 4,600 immigrant seniors, at an approximate cost of $46 million to $50 million a year, according to John Hoffman, a spokesperson for the Illinois Department of Healthcare and Family Services. Most of them would likely be undocumented.
Some Republicans criticized the coverage expansion, saying it was reckless at a time when Illinois’ finances are being shredded by the pandemic. The Illinois Republican Party deemed it “free healthcare for illegal immigrants.”
But proponents contend that many unauthorized immigrants pay taxes without being eligible for programs like Medicare and Medicaid, and that spending on preventive care saves money in the long run by cutting down on more expensive treatment for emergencies.
State Rep. Delia Ramirez, a Chicago Democrat who helped shepherd the legislation, advocated for a more expansive plan. She was inspired by her uncle, a 64-year-old immigrant who has asthma, diabetes and high blood pressure but no insurance. He has been working in the country for four decades.
She wanted the policy to apply to people 55 and older, since the vast majority of those who are undocumented are not seniors (she noted that a lot of older immigrants — 2.7 million, according to government estimates — obtained legal status under the 1986 federal amnesty law).
The real impact of this plan will likely be felt in years to come. At Esperanza Health Centers, one of Chicago’s largest providers of health care to immigrants, 31% of patients 65 and older lack coverage, compared with 47% of those 60 to 64, according to Jeffrey McInnes, who oversees patient access there.
Ramirez said her uncle called her after seeing news of the legislation on Spanish-language TV.
“And I said to him, ‘Tío, not yet. But when you turn 65, you’ll finally have health care, if we still can’t help you legalize,’” Ramirez recalled, choking up during a recent phone interview.
“So it is a reminder to me that, one, it was a major victory for us and it has meant life or a second chance at life for many people,” she said. “But it is also a reminder to me that we still have a long way to go in making health care truly a human right in the state and, furthermore, the nation.”
USE OUR CONTENT
This story can be republished for free (details).
SAN FRANCISCO — In early 2019, Tom Wolf posted a thank-you on Twitter to the cop who had arrested him the previous spring, when he was homeless and strung out in a doorway with 103 tiny bindles of heroin and cocaine in a plastic baggie at his feet.
“You saved my life,” wrote Wolf, who had finally gotten clean after that bust and 90 days in jail, ending six months of sleeping on scraps of cardboard on the sidewalk.
Today, he joins a growing chorus of people, including the mayor, calling for the city to crack down on an increasingly deadly drug trade. But there is little agreement on how that should be done. Those who demand more arrests and stiffer penalties for dealers face powerful opposition in a city with little appetite for locking people up for drugs, especially as the Black Lives Matter and Defund the Police movements push to drastically limit the power of law enforcement to deal with social problems.
Drug overdoses killed 621 people in the first 11 months of 2020, up from 441 in all of 2019 and 259 in 2018. San Francisco is on track to lose an average of nearly two people a day to drugs in 2020, compared with the 178 who had died by Dec. 20 of the coronavirus.
As in other parts of the country, most of the overdoses have been linked to fentanyl, the powerful synthetic opioid that laid waste to the eastern United States starting in 2013 but didn’t arrive in the Bay Area until about five years later. Just as the city’s drug scene was awash with the lethal new product — which is 50 times stronger than heroin and sells on the street for around $20 for a baggie weighing less than half a gram — the coronavirus pandemic hit, absorbing the attention and resources of health officials and isolating drug users, making them more likely to overdose.
The pandemic is contributing to rising overdose deaths nationwide, according to the Centers for Disease Control and Prevention, which reported last month that a record 81,000 Americans died of an overdose in the 12 months ending in May.
“This is moving very quickly in a horrific direction, and the solutions aren’t matching it,” said Supervisor Matt Haney, who represents the Tenderloin and South of Market neighborhoods, where nearly 40% of the deaths have occurred. Haney, who has hammered City Hall for what he sees as its indifference to a life-or-death crisis, is calling for a more coordinated response.
“It should be a harm reduction response, it should be a treatment response — and yes, there needs to be a law enforcement aspect of it too,” he said.
Tensions within the city’s leadership came to a head in September, when Mayor London Breed supported an effort by City Attorney Dennis Herrera to clean up the Tenderloin by legally blocking 28 known drug dealers from entering the neighborhood.
But District Attorney Chesa Boudin, a progressive elected in 2019 on a platform of police accountability and racial justice, sided with activists opposing the move. He called it a “recycled, punishment-focused” approach that would accomplish nothing.
People have died on the Tenderloin’s needle-strewn sidewalks and alone in hotel rooms where they were housed by the city to protect them from covid-19. Older Black men living alone in residential hotels are dying at particularly high rates; Blacks make up around 5% of the city’s population but account for a quarter of the 2020 overdoses. Last February, a man was found hunched over, ice-cold, in the front pew at St. Boniface Roman Catholic Church.
The only reason drug deaths aren’t in the thousands, say health officials, is the outreach that has become the mainstay of the city’s drug policy. From January to October, 2,975 deaths were prevented by naloxone, an overdose reversal drug that’s usually sprayed up the nose, according to the DOPE Project, a city-funded program that trains outreach workers, drug users, the users’ family members and others.
“If we didn’t have Narcan,” said program manager Kristen Marshall, referring to the common naloxone brand name, “there would be no room at our morgue.”
The city is also hoping that this year state lawmakers will approve safe consumption sites, where people can do drugs in a supervised setting. Other initiatives, like a 24-hour meth sobering center and an overhaul of the city’s behavioral health system, have been put on hold because of pandemic-strained resources.
Efforts like the DOPE Project, the country’s largest distributor of naloxone, reflect a seismic shift over the past few years in the way cities confront drug abuse. As more people have come to see addiction as a disease rather than a crime, there is little appetite for locking up low-level dealers, let alone drug users — policies left over from the “war on drugs” that began in 1971 under President Richard Nixon and disproportionately punished Black Americans.
In practice, San Francisco police don’t arrest people for taking drugs, certainly not in the Tenderloin. On a sunny afternoon in early December, a red-haired young woman in a beret crouched on a Hyde Street sidewalk with her eyes closed, clutching a piece of foil and a straw. A few blocks away, a man sat on the curb injecting a needle into a thigh covered with scabs and scars, while two uniformed police officers sat in a squad car across the street.
Last spring, after the pandemic prompted a citywide shutdown, police stopped arresting dealers to avoid contacts that might spread the coronavirus. Within weeks, the sidewalks of the Tenderloin were lined with transients in tents. The streets became such a narcotics free-for-all that many of the working-class and immigrant families living there felt afraid to leave their homes, according to a federal lawsuit filed by business owners and residents. It accuses City Hall of treating less wealthy ZIP codes as “containment zones” for the city’s ills.
The suit was settled a few weeks later after officials moved most of the tents to designated “safe sleeping sites.” But for many, the deterioration of the Tenderloin, juxtaposed with the gleaming headquarters of companies like Twitter and Uber just blocks away, symbolizes San Francisco’s starkest contradictions.
The Federal Initiative for the Tenderloin was one such effort, announced in 2019. It aims to “reclaim a neighborhood that is being smothered by lawlessness,” U.S. Attorney David Anderson said at a recent virtual news conference held to announce a major operation in which the feds arrested seven people and seized 10 pounds of fentanyl.
Law enforcement agencies have blamed the continued availability of cheap, potent drugs on lax prosecutions. Boudin, however, said his office files charges in 80% of felony drug cases, but most involve low-level dealers whom cartels can easily replace in a matter of hours.
He pointed to a 2019 federal sting that culminated in the arrest of 32 dealers — mostly Hondurans who were later deported — after a two-year undercover operation involving 15 agencies.
“You go walk through the Tenderloin today and tell me if it made a difference,” said Boudin.
His position reflects a growing “progressive prosecutor” movement that questions whether decades-old policies that focus on putting people behind bars are effective or just. In May, the killing of George Floyd by the Minneapolis police energized a nationwide police reform campaign. Cities around the country, including San Francisco, have promised to redirect millions of dollars from law enforcement to social programs.
“If our city leadership says in one breath that they want to defund the police and are for racial and economic justice and in the next talk about arresting drug dealers, they’re hypocrites and they’re wrong,” said Marshall, the leader of the DOPE Project.
But Wolf, 50, believes a concerted crackdown on dealers would send a message to the drug networks that San Francisco is no longer an open-air illegal drug market.
Like hundreds of thousands of other Americans who’ve succumbed to opiate misuse, he began with a prescription for the painkiller oxycodone, in his case following foot surgery in 2015. When the pills ran out, he made his way from his tidy home in Daly City, just south of San Francisco, to the Tenderloin, where dealers in hoodies and backpacks loiter three or four deep on some blocks.
When he could no longer afford pills, Wolf switched to heroin, which he learned how to inject on YouTube. He soon lost his job as a caseworker for the city and his wife threw him out, so he became homeless, holding large quantities of drugs for Central American dealers, who sometimes showed him photos of the lavish houses they were having built for their families back home.
Looking back, he wishes it hadn’t taken six arrests and three months behind bars before someone finally pushed him toward treatment.
“In San Francisco, it seems like we’ve moved away from trying to urge people into treatment and instead are just trying to keep people alive,” he said. “And that’s not really working out that great.”
USE OUR CONTENT
This story can be republished for free (details).
USE OUR CONTENT
This story can be republished for free (details).
It’s gotten so bad that Los Angeles County officials are warning paramedics to conserve it. Some hospitals are having to delay releasing patients as they don’t have enough oxygen equipment to send home with them.
“Everybody is worried about what’s going to happen in the next week or so,” said Cathy Chidester, director of the L.A. County Emergency Medical Services Agency.
Oxygen, which makes up 21% of the Earth’s air, isn’t running short. But covid damages the lungs, and the crush of patients in hot spots such as Los Angeles, the Navajo Nation, El Paso, Texas, and in New York last spring have needed high concentrations of it. That has stressed the infrastructure for delivering the gas to hospitals and their patients.
The strain in those areas is caused by multiple weak links in the pandemic supply chain. In some hospitals that pipe oxygen to patients’ rooms, the massive volume of cold liquid oxygen is freezing the equipment needed to deliver it, which can block the system.
“You can completely — literally, completely — shut down the entire hospital supply if that happens,” said Rich Branson, a respiratory therapist with the University of Cincinnati and editor-in-chief of the journal Respiratory Care.
There is also pressure on the availability of both the portable cylinders that hold oxygen and the concentrators that pull oxygen from the air. And in some cases, vendors that supply the oxygen have struggled to get enough of the gas to hospitals. Even nasal cannulas, the tubing used to deliver oxygen, are now running low.
“It’s been nuts, absolutely nuts,” said Esteban Trejo, general manager of Syoxsa, an industrial and medical gas distributor based in El Paso. He provides oxygen to several temporary hospitals set up specifically to treat people with covid.
In November, he said, he was answering calls in the middle of the night from contractors worried about oxygen supplies. At one point, when the company’s usual supplier fell through, they were hauling oxygen from Houston, which is a more than 10-hour drive each way.
Branson has been sounding the alarm about logistical limitations on critical care since the SARS pandemic nearly 20 years ago, when he and others surveyed experts about the specific equipment and infrastructure needed during a future pandemic. Oxygen was near the top of the list.
Oxygen as Cold as Neptune
Last spring, New York, New Jersey and Connecticut faced a challenge similar to what is now unfolding in Los Angeles, said Robert Karcher, a vice president of contract services for Acurity, a group purchasing organization that worked with many hospitals during that surge.
To take up less space, oxygen is often stored as a liquid around minus 300 degrees Fahrenheit, about as cold as the surface of Neptune. But as covid patients filling ICUs were given oxygen through ventilators or nasal tubes, some hospitals began to see ice form over the equipment that converts liquid oxygen into a gas.
When a hospital draws more and more liquid oxygen from those tanks, the super-cold liquid can seep further into the vaporizing coils where liquid oxygen turns to gas.
Branson said some ice is normal, but a lot of ice can cause valves on the device to freeze in place. And the ice can restrict airflow in the pipes sending the oxygen into patients’ rooms, Karcher said. To combat this, hospitals could switch to a backup vaporizer if they had one, hose down iced vaporizers or move patients to cylinder-delivered oxygen. But that puts additional strain on the hospitals’ cylinder oxygen supply, as well as the medical gas supplier, Karcher said.
Hospitals in New York began to panic in the spring because the icing of the vaporizer was much greater than they had seen before, he added. It got so bad, he said, that some hospitals worried they’d have to close their ICUs.
“They thought they were in imminent danger of their tank piping shutting down,” he said. “We came pretty close in a couple of our hospitals. It was a rough few weeks.”
The strain on Los Angeles health care infrastructure could be worse given the now-common treatment of putting patients on oxygen using high-flow nasal cannulas. That requires more of the gas pumped at a higher rate than with ventilators.
“I don’t know of any system that is really set to triple patient volumes — or 10 times the oxygen delivery,” Chidester said of the L.A. County hospitals. “They’re having a hard time keeping up.”
The Oxygen Shortage Doom Loop
In and around Los Angeles, the Army Corps of Engineers has so far surveyed 11 hospitals for freezing oxygen pipe issues. The hospitals are a mix of older facilities and smaller suburban hospitals seeing such high demand amid skyrocketing cases in the area, said Mike Petersen, a Corps spokesperson.
One of the worst examples he saw included pipes that looked like a home freezer that had not been defrosted in some time.
The problem gets worse for hospitals that have had to convert regular hospital rooms to intensive care units. ICU pipes are bigger than those leading to other parts of a hospital. When rooms get repurposed as pop-up ICUs, the pipes can simply be too narrow to deliver the oxygen that covid patients need. And so, Chidester said, the hospitals switch to large cylinders of oxygen. But vendors are having a hard time refilling those quickly enough.
Even smaller cylinders and oxygen concentrators are in short supply amid the surge, she said. Those patients who could be sent home with an oxygen cylinder are left stuck in a hospital waiting for one, taking up a much-needed bed.
In early December, doctors serving the Navajo Nation said they needed more of everything: the oxygen itself and the equipment to get oxygen to patients both in the hospital and recovering at home.
“We’ve never reached capacity before — until now,” said Dr. Loretta Christensen, chief medical officer for the Navajo Area Indian Health Service, in mid-December. Its hospitals serve a patient population in the southwestern U.S. that’s spread across an area bigger than West Virginia.
The buildings are aging, and they aren’t built to house a large number of critical patients, said Christensen. As the number of patients on high-flow oxygen climbed, several facilities started to notice their oxygen flow weaken. They thought something was broken, but when engineers took a look, Christensen said, it became clear the system was just not able to provide the amount of high-flow oxygen patients needed.
She said a hospital in Gallup, New Mexico, put in new filters to maximize oxygen flow. After delays from snowy weather, a hospital serving the northern part of the Navajo Nation managed to hook up a second oxygen tank to boost capacity.
But medical facilities in the area are always a little on edge.
“Honestly, we worry about supply a lot out here because — and I call it extreme rurality — you just can’t get something tomorrow,” said Christensen. “It’s not like being in an urban area where you can say, ‘Oh, I need this right now.’”
Because of the small size of certain hospitals and the difficulty of getting to some of them, Christensen said, Navajo facilities aren’t attractive to big vendors, so they rely on local vendors, which may prove more vulnerable to supply chain hiccups.
Tséhootsooí Medical Center in Fort Defiance, Arizona, has at times had to keep patients in the hospital and transfer incoming patients to other facilities because it couldn’t get the oxygen cylinders needed to send recovering patients home.
Tina James-Tafoya, covid incident commander at Fort Defiance Indian Hospital Board, which runs the center, said at-home oxygen is out of the question for some patients. Oxygen concentrators require electricity, which some patients don’t have. And for patients who live in hogans, homes often heated with a wood stove, the use of oxygen cylinders is a hazard.
“It’s really interesting and eye-opening for me to see that something that seems so simple like oxygen has so many different things tied to it that will hinder it getting to the patient,” she said.
USE OUR CONTENT
This story can be republished for free (details).
In mid-June, Catalyst launched the Robert Wood Johnson Foundation Emergency Response Innovation Challenges. These Challenges, one for the General Public and one for the Health Care System, asked innovators to develop a health technology tool to support the needs of individuals as well as health care systems affected by a large-scale health crisis, such as a pandemic or natural disaster.
The Challenges saw a record number of applications— nearly 125 applications were submitted to the General Public Challenge and over 130 applications were submitted to the Health Care System Challenge. Over the course of several months and with the help of experts and industry leaders who evaluated the submissions, these applications were narrowed down to five and then again until only three teams per Challenge remained. These teams were:
Emergency Response for the General Public Finalists:
- Binformed Covidata– Binformed is a clinically-driven comprehensive desktop + mobile infectious disease, epidemic + pandemic management tool targeting suppression and containment of diseases such as COVID-19.
- CovidSMS– CovidSMS is a text message-based platform providing city-specific information and resources to help low-income communities endure COVID-19.
- Fresh EBT by Propel– A technology tool for SNAP families to address food insecurity & economic vulnerability in times of crisis.
Emergency Response for the Health Care System Finalists:
- Path Check– Path Check provides privacy first, free, open source solutions for public health to supplement manual contact tracing, visualize hot spots, and interfaces with citizen-facing privacy first apps.
- Qventus– Qventus is a patient flow automation solution that applies AI / ML and behavioral science to help health systems optimize resources for Covid, create effective capacity, and reduce frontline burnout.
- Tiatros– A mental health and social support platform that combines clinical expertise, peer communities and scalable technology to advance mental wellbeing and to sustain meaningful behavioral change.
These six teams competed in the finals, a virtual pitch event, on November 19th in front of expert judging panels, who evaluated the entries on impact, UX/UI, innovation/creativity, scalability and strength of presentation. (Also re-introduced during this event was Catalyst’s SourceDB, a health tech tracking database – more on that in a separate blog post here!)
In the Health Care System Innovation Challenge, judges awarded first, second, and third place to Qventus, Path Check, and Tiatros, Inc., respectively, with these teams receiving, in order, $25,000, $15,000, and $5,000. However, there was a tie for first in the General Public Innovation Challenge between binformed | covidata and CovidSMS. These two teams split the first and second place prizes and received $17,500 each, and Fresh EBT by Propel in third place received $5,000.
See the demos from all six teams below!
Health Care System:
Missed the event? View the full recording below:
We follow up with the winners of the Challenges in a separate blog post here
To learn more about the two Challenges, please visit the Challenge websites, bit.ly/genpublicresponse and bit.ly/healthcareresponse
Elizabeth Brown is a Program Manager at Catalyst @ Health 2.0
- The US FDA has granted EUA to Nirmidas’ COVID-19 rapid antibody IgG/IgM test for use in POC settings, delivering results in 15-20min
- Using a fingerstick serology test, the MidaSpot COVID-19 Ab combo detection kit checks for Ab against the RBD antigen and showed 100% sensitivity for IgG after 14 days post symptom onset and 100% sensitivity for IgM after 7 days post symptom onset
- With this, Nirmidas became the first US company to receive EUA for a COVID-19 POC fingerstick Ab test. The kit can now be administered in CLIA-waived settings for POC testing such as doctor’s offices, pharmacies, ERs
Click here to read full press release/ article | Ref: Businesswire | Image: Yahoo Finance
The post Nirmidas Receives the US FDA’s EUA for its COVID-19 Rapid Antibody Fingerstick Test first appeared on PharmaShots.
The UK government has promised a “massive uplift” in the number of coronavirus vaccinations carried out this week, while conceding a target of 13.9 million jabs offered by the end of February will be “challenging”.
As the number of daily recorded cases in the country exceeded 60,000 for the first time, vaccine minister Nadhim Zahawi told BBC Radio 4’s today programme: “My absolute focus is to get to 13.9 million…offered a vaccine by the middle of February.
“That is my target and I’m confident the NHS has a plan and we will meet that target.”
The number of vaccinations will continue to rise, he promised, adding that a quarter of over-80s had already been vaccinated.
Zahawi stopped short of saying when the government would reach the 300,000 vaccinations a day required to meet the goal.
More than a million people are thought to be infected with virus at the moment and hospitals across in the worst-affected areas are running at full capacity because of the disease.
All of the country is now in a strict lockdown, with mixing indoors banned and people instructed to stay except to get exercise and other essential tasks such as buying food.
According to reports elsewhere there are a number of backlogs that are causing delays to the roll-out of the vaccine from AstraZeneca, which will be offered to the majority of patients.
The UK has ordered 100 million doses of the vaccine and AZ has reportedly manufactured around 3.5 million doses in addition to the half million or so shots that are already available.
But Sky News reported that the extra doses are still waiting to be batch tested by the country’s regulator, the Medicines and Healthcare Products Regulatory Agency.
Sky reported that the MHRA is working in parallel with AstraZeneca’s own batch testing system to speed up a process that usually takes up to three weeks.
There are also issues with Pfizer/BioNTech vaccine, which is not manufactured in the UK like the AZ shot but in Belgium.
It has already been placed into glass vials by the time it arrives in the country, but a worldwide shortage of these means that five million doses have been delivered.
This is less than half the number that should have been because of the problems with manufacturing including the fill-and-finish process, according to the BBC.
Feature image courtesy of NIH/Rocky Mountain Laboratories
The post UK promises ‘uplift’ in COVID-19 vaccinations as crisis deepens appeared first on .
The UK government agency NHS Digital has awarded an £8m digital system that processes coronavirus test results to healthcare software specialist X-Lab without competition.
According to a tender document, the “extreme urgency brought about by the COVID-19 pandemic situation” justified the decision not to open up the contract to competition.
The document added that the technical demands for the project mean that X-Labs is the only provider capable of fulfilling the contract.
Specialist tech website The Register reported that the contract will be to “deliver the digital service” supporting coronavirus service.
It will require a messaging service allowing pathology labs to communicate so all test results and requests can be processed digitally.
The system will underpin the NHS COVID-19 Test and Trace system known as “pillar 2”, which is based on swab testing for the wider population.
It will also help “pillar 3” testing, which shows whether people have antibodies against COVID-19 after contracting it.
Based in Leeds, X-Lab is a private software company that already has experience with the NHS after building the National Pathology Exchange (NPEx), which ensures coronavirus test results are matched to patient records.
This system links laboratories including private facilities with the NHS Business Services Authority, which informs patients of their test results.
In England, the NPEx links to GP records, using details from NHS Digital or Public Health England.
The IT infrastructure underpinning the UK’s testing system has proved controversial in recent months.
Early in October it emerged that data from “pillar 2” private testing labs had been stored on an Excel spreadsheet.
But limitations on the size of the spreadsheet caused thousands of positive results from the labs hired to provide extra capacity to be omitted from the UK’s official records.
This caused official records to show that numbers of infections were stable or falling when in fact around 16,000 positive results were missing from public records.
The post NHS Digital awards £8m COVID record contract to X-lab appeared first on .
Use Our Content
It can be republished for free.
Krissy Williams, 15, had attempted suicide before, but never with pills.
The teen was diagnosed with schizophrenia when she was 9. People with this chronic mental health condition perceive reality differently and often experience hallucinations and delusions. She learned to manage these symptoms with a variety of services offered at home and at school.
But the pandemic upended those lifelines. She lost much of the support offered at school. She also lost regular contact with her peers. Her mother lost access to respite care — which allowed her to take a break.
On a Thursday in October, the isolation and sadness came to a head. As Krissy’s mother, Patricia Williams, called a mental crisis hotline for help, she said, Krissy stood on the deck of their Maryland home with a bottle of pain medication in one hand and water in the other.
Before Patricia could react, Krissy placed the pills in her mouth and swallowed.
Efforts to contain the spread of the novel coronavirus in the United States have led to drastic changes in the way children and teens learn, play and socialize. Tens of millions of students are attending school through some form of distance learning. Many extracurricular activities have been canceled. Playgrounds, zoos and other recreational spaces have closed. Kids like Krissy have struggled to cope and the toll is becoming evident.
Government figures show the proportion of children who arrived in emergency departments with mental health issues increased 24% from mid-March through mid-October, compared with the same period in 2019. Among preteens and adolescents, it rose by 31%. Anecdotally, some hospitals said they are seeing more cases of severe depression and suicidal thoughts among children, particularly attempts to overdose.
The increased demand for intensive mental health care that has accompanied the pandemic has worsened issues that have long plagued the system. In some hospitals, the number of children unable to immediately get a bed in the psychiatric unit rose. Others reduced the number of beds or closed psychiatric units altogether to reduce the spread of covid-19.
“It’s only a matter of time before a tsunami sort of reaches the shore of our service system, and it’s going to be overwhelmed with the mental health needs of kids,” said Jason Williams, a psychologist and director of operations of the Pediatric Mental Health Institute at Children’s Hospital Colorado.
“I think we’re just starting to see the tip of the iceberg, to be honest with you.”
Before covid, more than 8 million kids between ages 3 and 17 were diagnosed with a mental or behavioral health condition, according to the most recent National Survey of Children’s Health. A separate survey from the Centers for Disease Control and Prevention found 1 in 3 high school students in 2019 reported feeling persistently sad and hopeless — a 40% increase from 2009.
The coronavirus pandemic appears to be adding to these difficulties. A review of 80 studies found forced isolation and loneliness among children correlated with an increased risk of depression.
“We’re all social beings, but they’re [teenagers] at the point in their development where their peers are their reality,” said Terrie Andrews, a psychologist and administrator of behavioral health at Wolfson Children’s Hospital in Florida. “Their peers are their grounding mechanism.”
Children’s hospitals in New York, Colorado and Missouri all reported an uptick in the number of patients who thought about or attempted suicide. Clinicians also mentioned spikes in children with severe depression and those with autism who are acting out.
The number of overdose attempts among children has caught the attention of clinicians at two facilities. Andrews from Wolfson Children’s said the facility gives out lockboxes for weapons and medication to the public — including parents who come in after children attempted to take their life using medication.
Children’s National Hospital in Washington, D.C., also has experienced an uptick, said Dr. Colby Tyson, associate director of inpatient psychiatry. She’s seen children’s mental health deteriorate due to a likely increase in family conflict — often a consequence of the chaos caused by the pandemic. Without school, connections with peers or employment, families don’t have the opportunity to spend time away from one another and regroup, which can add stress to an already tense situation.
“That break is gone,” she said.
The higher demand for child mental health services caused by the pandemic has made finding a bed at an inpatient unit more difficult.
Now, some hospitals report running at full capacity and having more children “boarding,” or sleeping in emergency departments before being admitted to the psychiatric unit. Among them is the Pediatric Mental Health Institute at Children’s Hospital Colorado. Williams said the inpatient unit has been full since March. Some children now wait nearly two days for a bed, up from the eight to 10 hours common before the pandemic.
Cincinnati Children’s Hospital Medical Center in Ohio is also running at full capacity, said clinicians, and had several days in which the unit was above capacity and placed kids instead in the emergency department waiting to be admitted. In Florida, Andrews said, up to 25 children have been held on surgical floors at Wolfson Children’s while waiting for a spot to open in the inpatient psychiatric unit. Their wait could last as long as five days, she said.
Multiple hospitals said the usual summer slump in child psychiatric admissions was missing last year. “We never saw that during the pandemic,” said Andrews. “We stayed completely busy the entire time.”
Some facilities have decided to reduce the number of beds available to maintain physical distancing, further constricting supply. Children’s National in D.C. cut five beds from its unit to maintain single occupancy in every room, said Dr. Adelaide Robb, division chief of psychiatry and behavioral sciences.
The measures taken to curb the spread of covid have also affected the way hospitalized children receive mental health services. In addition to providers wearing protective equipment, some hospitals like Cincinnati Children’s rearranged furniture and placed cues on the floor as reminders to stay 6 feet apart. UPMC Western Psychiatric Hospital in Pittsburgh and other facilities encourage children to keep their masks on by offering rewards like extra computer time. Patients at Children’s National now eat in their rooms, a change from when they ate together.
Despite the need for distance, social interaction still represents an important part of mental health care for children, clinicians said. Facilities have come up with various ways to do so safely, including creating smaller pods for group therapy. Kids at Cincinnati Children’s can play with toys, but only with ones that can be wiped clean afterward. No cards or board games, said Dr. Suzanne Sampang, clinical medical director for child and adolescent psychiatry at the hospital.
“I think what’s different about psychiatric treatment is that, really, interaction is the treatment,” she said, “just as much as a medication.”
The added infection-control precautions pose challenges to forging therapeutic connections. Masks can complicate the ability to read a person’s face. Online meetings make it difficult to build trust between a patient and a therapist.
“There’s something about the real relationship in person that the best technology can’t give to you,” said Robb.
For now, Krissy is relying on virtual platforms to receive some of her mental health services. Despite being hospitalized and suffering brain damage due to the overdose, she is now at home and in good spirits. She enjoys geometry, dancing on TikTok and trying to beat her mother at Super Mario Bros. on the Wii. But being away from her friends, she said, has been a hard adjustment.
“When you’re used to something,” she said, “it’s not easy to change everything.”
If you have contemplated suicide or someone you know has talked about it, call the National Suicide Prevention Lifeline at 1-800-273-8255, or use the online Lifeline Crisis Chat, both available 24 hours a day, seven days a week.
USE OUR CONTENT
This story can be republished for free (details).