Vaccine

Sanofi snaps up acne vaccine developer Origimm Bio

Sanofi has added to its vaccine pipeline with an agreement to acquire Austria’s Origimm Biotechnology and its vaccine-based immunotherapy for people with acne. The French group said that ORI-001, a vaccine based on recombinant proteins from the  Cutibacterium acnes (formerly Propionibacterium acnes) bacterium that is often found in acne lesions, could be the first ever …

Sanofi snaps up acne vaccine developer Origimm Bio Read More »

Report suggests UK’s national vaccine facility is on the block

The UK’s Vaccines Manufacturing and Innovation Centre (VMIC) – unveiled with fanfare by the government in 2018 – is rumoured to be up for sale. The facility at the Harwell Science and Innovation Campus in Oxford has received £215 million in public money since it was announced, and several companies have submitted bids for the …

Report suggests UK’s national vaccine facility is on the block Read More »

Trial of intranasal Alzheimer’s vaccine gets underway in US

The first patients are now being treated as part of a first-in-human trial of a vaccine, administered as a nasal spray, that aims to slow down the progression of Alzheimer’s disease (AD). Researchers at Brigham and Women’s Hospital in Boston, US, hope that the vaccine will stimulate the immune system to clear the amyloid plaques …

Trial of intranasal Alzheimer’s vaccine gets underway in US Read More »

Vaccibody rebrands as Nykode, and unveils big Regeneron partnership

Norwegian biotech Vaccibody has changed its name to Nykode Therapeutics, and celebrated its new identity with a sizeable deal with Regeneron to develop vaccines for cancer and infectious diseases. The Oslo-based company is getting $50 million upfront from Regeneron – split between cash and an equity investment – with another $875 million on the table …

Vaccibody rebrands as Nykode, and unveils big Regeneron partnership Read More »

Study shows HPV jab almost 90% effective at preventing cervical cancer

Routine vaccination with human papillomavirus vaccines have resulted in an 87% reduction in cervical cancer cases in England, and could even see the need for smear tests phased out in future, according to a new study. The jabs with have been offered by the NHS to girls between the ages of 12 and 13 since …

Study shows HPV jab almost 90% effective at preventing cervical cancer Read More »

Vaccine hesitancy in low- and middle-income countries

While the recently developed COVID-19 vaccines offer the hope of ending the pandemic, ending the pandemic is only feasible if individuals take the vaccine. In the US, a large portion of individuals report being hesitant to receive the vaccine. A key question then is whether individuals living in low and middle-income countries (LMIC) are have …

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The “Secret Sauce” – A Comparison of TSMC and Pfizer

By MIKE MAGEE This week’s Tom Friedman Opinion piece in the New York Times contained a title impossible to ignore: “China’s Bullying Is Becoming a Danger To The World and Itself.” The editorial has much to recommend it. But the item that caught my eye was Friedman’s full-throated endorsement of Taiwan’s “most sophisticated microchip manufacturer in the …

The “Secret Sauce” – A Comparison of TSMC and Pfizer Read More »

GSK’s malaria vaccine gets WHO okay for mass rollout

The WHO has given a green light to widespread use of GlaxoSmithKline’s malaria vaccine in Africa, in what could be a major turning point in the fight against the disease. The RTS,S/AS01 vaccine – also known as Mosquirix – will be administered to children living in sub-Saharan Africa and other regions with moderate to high …

GSK’s malaria vaccine gets WHO okay for mass rollout Read More »

Booster data backs Pfizer, Valneva Lyme disease vaccine

Prospects for Valneva’s COVID-19 vaccine are up in the air, but another candidate partnered with Pfizer looks increasingly like it could fill the void of an effective shot for Lyme disease. New phase 2 data with their VLA15 vaccine shows that antibody responses from an initial three-dose regimen are initially high, although they start to …

Booster data backs Pfizer, Valneva Lyme disease vaccine Read More »

Contact-tracing apps ‘could improve COVID vaccination strategy’

Targeting people for COVID-19 vaccination using contract-tracing apps could be a shortcut to achieving herd immunity in the population using fewer doses, according to Canadian researchers. According to Mark Penney, Yigit Yargic and colleagues from the Perimeter Institute for Theoretical Physics in Ontario, targeting vaccines to people who have more exposure than others is the …

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Analysis: Cost of care for unvaccinated Covid patients spikes to $5.7B

The cost of hospital care for unvaccinated Covid-19 patients has more than doubled, jumping from about $2 billion to $5.7 billion over the summer. And this figure may still be lower than the actual cost burden unvaccinated people represent to the healthcare system.

As Delta surges, CMIOs’ focus on plans to provide vaccine booster shots, fight false information

Chief medical information officers are in a unique position to help their organizations fight the Covid-19 pandemic — from setting up IT systems to support Covid testing, care and vaccination to helping fight fast-spreading misinformation.

Pfizer raises pressure on GSK, J&J with late-stage RSV vaccine trial

Pfizer has vaulted ahead with its respiratory syncytial virus (RSV) vaccine, closing the gap with GlaxoSmithKline and Johnson & Johnson as the companies strive to bring the first licensed shot to market. The first of an anticipated 30,000 subjects have been vaccinated in Pfizer’s phase 3 RENOIR trial of its vaccine, just behind GSK and …

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Merck raises pressure on Pfizer in pneumococcal vaccine tussle

Just a month after getting approval for its new pneumococcal vaccine Vaxneuvance in adults, Merck & Co has reported positive trial results in children that will ramp up the pressure on Pfizer and its market-leading Prevnar franchise. The 15-valent conjugate vaccine was at least as effective as Pfizer’s 13-valent Prevnar 13 in the study, which …

Merck raises pressure on Pfizer in pneumococcal vaccine tussle Read More »

Analysis: Care for the unvaccinated may be costing U.S. healthcare system $2.3B

The report, released by Kaiser Family Foundation and the Peterson Center on Healthcare, details the high cost of Covid care for the unvaccinated. In fact, the analysis indicates the figure could be even higher than $2.3 billion, as the authors did not take into account the cost of outpatient treatment for Covid-19.

Providers will likely face more lawsuits against vaccine mandates. But they are also more likely to win.

Providers’ legal defense against lawsuits aiming to tear down vaccine mandates is wide-ranging, from making the argument that allowing an unvaccinated worker into their facilities could pose a direct threat to the worker to invoking a 1905 precedent set by the Supreme Court.

Boost vaccination rates with frictionless self-scheduling

It’s time to accelerate the pace of COVID-19 vaccinations. Healthcare experts are increasingly concerned about the rapid spread of the highly contagious delta variant, which now makes up over 83% of COVID-19 cases. This variant is estimated to be 60% more transmissible than previous strains, and while vaccination doesn’t eliminate the risk, it does reduce …

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Boost vaccination rates with frictionless self-scheduling

As the country strives to ramp up the pace of COVID-19 vaccinations, providers need to take new approaches to drive registration volume. Healthcare experts are increasingly concerned about the rapid spread of the highly contagious delta variant, which now makes up over 83% of COVID-19 cases. This variant is estimated to be 60% more transmissible …

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Sanofi swoops on partner Translate, buying the mRNA firm for $3.2bn

Sanofi has been forging ever-closer ties with its mRNA partner Translate Bio since the two started working together in 2018, and has now gone all in, offering $3.2 billion to buy the company outright. The $38-per-share deal – a 56% premium to Translate’s recent share price before an after-hours surge in the stock on rumours …

Sanofi swoops on partner Translate, buying the mRNA firm for $3.2bn Read More »

Takeda spins norovirus vaccine out into separate company

Takeda has decided development of its norovirus vaccine candidate outside Japan will be more efficient if it is spun out into a dedicated company. The Japanese drugmaker has partnered with venture capital company Frazier Healthcare Partners to form HilleVax, which comes into being with full and exclusive ex-Japanese development and commercial rights to TAK-214 (now …

Takeda spins norovirus vaccine out into separate company Read More »

Medicare vaccine coverage (including how the COVID-19 vaccines are covered)

How does Medicare cover vaccines? Are the paid for by Medicare Part B or Part D? MedPAC’s June 2021 report provides a nice overview. Medicare covers vaccines under Part B and Part D. Part B covers vaccines for influenza, pneumococcal disease, hepatitis B (for patients at high or intermediate risk), and coronavirus disease 2019 (COVID-19), …

Medicare vaccine coverage (including how the COVID-19 vaccines are covered) Read More »

World Hepatitis Day 2021

Every 30 seconds, a person dies from a hepatitis-related illness. This terrible death toll is why the mantra for World Hepatitis Day (July 28) this year is “Hepatitis Can’t Wait”. Hepatitis is an inflammation of the liver, usually caused by a viral infection. Different hepatitis viruses are transmitted in different ways – for instance, Hepatitis …

World Hepatitis Day 2021 Read More »

Shot in the arm for Affinivax as it challenges Pfizer’s Prevnar

Already facing one rival to its blockbuster pneumococcal vaccine Prevnar, Pfizer could have another to contend with, after Affinivax reported positive phase 2 results with its ASP3772 candidate – plus a new breakthrough designation from the FDA. Last year, Pfizer made almost $6 billion from its Prevnar 13 vaccine, which covers 13 common serotypes of …

Shot in the arm for Affinivax as it challenges Pfizer’s Prevnar Read More »

Moderna plans triple vaccine targeting flu, COVID and RSV

Buoyed by the success of its COVID-19 vaccine, Moderna has started a phase 1/2 trials of its mRNA-based shot for seasonal influenza, targeting four different flu strains.  The first patents have now been enrolled into the study of the shot – codenamed mRNA-1010 – which is designed to generate antibodies against influenza A H1N1, H3N2 …

Moderna plans triple vaccine targeting flu, COVID and RSV Read More »

COVID-19 vaccine development: Safety monitoring continues revolution in RWD

From cancer to COVID, real-world data is changing the way we research therapeutics, monitor safety, and collaborate on the development of treatments designed to improve outcomes for patients in need. In today’s feature, Dr. Miruna Sasu lays out how real-world data is evolving in the post COVID-19 vaccine reality.  Only a year after the emergence …

COVID-19 vaccine development: Safety monitoring continues revolution in RWD Read More »

COVID-19 vaccine development: Safety monitoring continues revolution in RWD

From cancer to COVID, real-world data is changing the way we research therapeutics, monitor safety, and collaborate on the development of treatments designed to improve outcomes for patients in need. In today’s feature, Dr. Miruna Sasu lays out how real-world data is evolving in the post COVID-19 vaccine reality.  Only a year after the emergence …

COVID-19 vaccine development: Safety monitoring continues revolution in RWD Read More »

AstraZeneca’s COVID-19 Vaccine Demonstrates 92% Efficacy Against Delta (Indian) Variant

Shots: Real world data from PHE demonstrated two doses of AZ’s vaccine are 92% effective against hospitalization due to the Delta variant and showed no deaths among the vaccinated The vaccine was highly effective against the Alpha variant (kent variant) with an 86% reduction of hospitalizations and no reported deaths. Vaccine effectiveness against the symptomatic …

AstraZeneca’s COVID-19 Vaccine Demonstrates 92% Efficacy Against Delta (Indian) Variant Read More »

Moderna’s mRNA-1273 Meets its Primary Endpoint in P-II/III TeenCOVE Study to Prevent COVID 19 in Adolescents

Shots: The P-II/III TeenCOVE study involves assessing mRNA-1273 (two 100 µg doses) vs PBO in 3700+ participants in a ratio (2:1) aged 12 to <18yrs. in the US The study met its 1EPs i.e non-inferior immunogenicity and demonstrated 93% efficacy in seronegative participants after 14 days following the first dose, was generally well tolerated with …

Moderna’s mRNA-1273 Meets its Primary Endpoint in P-II/III TeenCOVE Study to Prevent COVID 19 in Adolescents Read More »

Japan approves two more COVID vaccines as fourth infection wave hits

Japan has approved two more coronavirus vaccines, while expanding a state of emergency to cover the southern island of Okinawa. The two newly approved vaccines are from Moderna and AstraZeneca and will be added to a vaccine drive that began in mid-February using the Pfizer/BioNTech shot. However Reuters reported that the AstraZeneca vaccine will not …

Japan approves two more COVID vaccines as fourth infection wave hits Read More »

Moderna’s COVID-19 Vaccine Receives Approval for Emergency Use in Japan

Shots: MHLW has granted special approval under article 14-3 of the PMDA for emergency use of Moderna’s mRNA COVID-19 vaccine based on Takeda’s P-I/II immunogenicity and safety clinical trial The interim analysis showed that binding Ab and neutralizing Ab titers were elevated @28days after the second dose in 100% of people vaccinated with two 0.5ml …

Moderna’s COVID-19 Vaccine Receives Approval for Emergency Use in Japan Read More »

Sanofi/GSK move latecomer COVID-19 shot into phase 3

Sanofi and GlaxoSmithKline seem to be getting somewhere with their COVID-19 vaccine at last, announcing plans to move to phase 3 following supportive mid-stage trial results. In a statement the companies said that if the late-stage trial and regulatory reviews go well, the vaccine is expected to be approved in the fourth quarter of this …

Sanofi/GSK move latecomer COVID-19 shot into phase 3 Read More »

Sanofi and GSK Report Results of its COVID-19 Vaccine in a P-II Study Across All Adult Age Groups

Shots: The vaccine has achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19, in all adult age groups in a P-II study The results showed 95%-100% seroconversion following the second injection in all age groups (18-95yrs. old) & across all doses, with acceptable tolerability & …

Sanofi and GSK Report Results of its COVID-19 Vaccine in a P-II Study Across All Adult Age Groups Read More »

Novavax delays COVID vaccine filings until Q3

Novavax has finally provided some clarity about when its long-awaited COVID-19 vaccine will be ready, saying regulatory filings in the US, UK and Europe are due in the third quarter. The vaccine could play an important role in the next stage of the pandemic as phase 3 trials have shown encouraging safety and efficacy data. …

Novavax delays COVID vaccine filings until Q3 Read More »

FDA authorises Pfizer/BioNTech vaccine for adolescents

The FDA has authorised Pfizer/BioNTech’s vaccine for 12- to 15 year-olds under emergency rules. In a statement the regulator said it had expanded the vaccine’s Emergency Use Authorization to include the new age group. The vaccine was first approved under the emergency protocols on 11th December, for people aged 16 years of age and older. …

FDA authorises Pfizer/BioNTech vaccine for adolescents Read More »

Coronavirus won’t be circulating in UK by August, says outgoing vaccine chief Clive Dix

Coronavirus won’t be circulating in the UK by August, according to the outgoing chief of the country’s vaccine rollout scheme, Dr Clive Dix. Dix led the programme from December until he stepped down last week and told the Daily Telegraph that the UK’s vaccination campaign should be enough to protect from the virus and its …

Coronavirus won’t be circulating in UK by August, says outgoing vaccine chief Clive Dix Read More »

Pfizer shares slump as support grows for COVID-19 vaccine patent waiver

Shares in COVID-19 vaccine manufacturers have taken a hit after the US signalled its support for waiving patents on them, a moved aimed to boost global supplies of the life-saving shots. Waiving the patent on proprietary knowledge would allow it to be shared with other manufacturers and the matter is being discussed by the World …

Pfizer shares slump as support grows for COVID-19 vaccine patent waiver Read More »

EU starts rolling review of Sinovac’s COVID-19 vaccine

Europe’s regulator has begun a rolling review of Sinovac’s COVID-19 vaccine, known as Vero Cell. The vaccine is based on an inactivated SARS-CoV-2 virus, which has been killed and cannot cause COVID-19. In a statement, the European Medicines Agency said the rolling review is based on non-clinical and clinical studies suggesting the vaccine triggers production …

EU starts rolling review of Sinovac’s COVID-19 vaccine Read More »

UK orders 60m ‘booster’ doses of Pfizer/BioNTech COVID vaccine

The UK has ordered an extra 60 million doses of the Pfizer/BioNTech COVID-19 vaccine, which could be used as a potential booster campaign in the autumn. Health secretary Matt Hancock made the announcement in a press briefing, revealing that officials think they may have to boost protection for the population during the winter. The UK …

UK orders 60m ‘booster’ doses of Pfizer/BioNTech COVID vaccine Read More »

European Commission legal battle with AZ over COVD vaccines contract

The European Commission has officially begun legal proceedings against AstraZeneca over supplies of COVID vaccines. The legal action marks an escalation in the dispute between the EU and AZ over the supply of coronavirus vaccines. Under pressure to roll out vaccinations, the European Commission has accused AZ of failing to live up to a contract …

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Oxford’s malaria shot set for phase 3 test after ‘unprecedented’ 77% efficacy

Following the success of the coronavirus vaccine developed with AstraZeneca, Oxford University’s Jenner Institute has unveiled trial results showing its experimental malaria shot could be around 77% effective. There is a malaria vaccine on the market – GlaxoSmithKline’s Mosquirix – but this is only around 39% effective in young children and has not been backed …

Oxford’s malaria shot set for phase 3 test after ‘unprecedented’ 77% efficacy Read More »

EU safety regulators clear J&J COVID shot despite tiny clot risk

The benefits of Johnson & Johnson’s COVID-19 vaccine outweigh a tiny risk of unusual blood clots forming, Europe’s drugs regulator has said. In a decision that will allow the rollout of vaccines in certain EU states, the European Medicines Agency’s safety committee said there appears to be a link to unusual blood clots combined with …

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Risk of brain clots higher with COVID than vaccine, study suggests

A study has suggested that the risk of getting a serious brain clot is eight to 10 times higher in people with COVID-19 than those who get a vaccine. There are some big caveats with the research from Oxford University – it was based on data from people in the US who had received either …

Risk of brain clots higher with COVID than vaccine, study suggests Read More »

Czech Republic swoops for Denmark’s 2.4m unwanted AZ COVID shots

The Czech Republic wants to buy around 2.4 million doses of the AstraZeneca/Oxford University vaccine ditched by Denmark, which has said it will stop using it because of concerns about rare blood clotting side-effects. Czech deputy prime minister Jan Hamacek said on twitter that he had instructed the country’s ambassador in Denmark to try to …

Czech Republic swoops for Denmark’s 2.4m unwanted AZ COVID shots Read More »

J&J Pauses Dosing of COVID-19 Vaccine Due to Blood Clotting

Shots: J&J temporarily pause the use of the COVID-19 vaccine in the US, following recommended of the CDC and FDA. The review data involves six reported cases of a rare and severe type of blood clot in the US after receiving the J&J vaccine The pause is due to the unusual clotting in 6 women …

J&J Pauses Dosing of COVID-19 Vaccine Due to Blood Clotting Read More »

England begins Moderna vaccine rollout as lockdown eases

England is beginning its rollout of the Moderna COVID-19 vaccine, offering an alternative to the AstraZeneca/Oxford University jab following a potential link to a very rare kind of blood clot. The Moderna shot is the third vaccine to become available in the country, which has made considerable progress with its inoculation campaign. Its arrival is …

England begins Moderna vaccine rollout as lockdown eases Read More »

South African variant may evade Pfizer/BioNTech vaccine, study finds

The coronavirus variant discovered in South Africa may evade Pfizer/BioNTech’s vaccine, according to a real-world data study conducted in Israel. Known as variant B.1.351, the variant was found to make up around 1% of all COVID-19 cases across the people studied according to results which have yet to be peer-reviewed. But among patients who had …

South African variant may evade Pfizer/BioNTech vaccine, study finds Read More »

Poll: About half of healthcare workers feel burned out, anxious when going to work

Though a majority of healthcare workers believe that the pandemic is at least somewhat under control now, about half still feel anxious or burned out when going to work, a new survey shows. Pandemic-related stress has also given rise to physical issues among healthcare workers, including trouble sleeping and headaches.

World leaders call for international pandemic preparedness treaty

More than 20 world leaders have called for an international treaty for pandemic preparedness to protect the world from future health crises. Backed by the World Health Organization, the treaty would “dispel the temptations of isolationism and nationalism” in the event of another crisis such as COVID-19. In a commentary backed by the 24 leaders, …

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EU stops short of vaccine export controls after summit

The European Union has stopped short of export controls on vaccines after leaders met at a summit to discuss the issue of shortfalls in supply. At the meeting of the European Council leaders said that toughening export controls was an option but a post-summit statement emphasised the importance of global supply chains to produce vaccines. …

EU stops short of vaccine export controls after summit Read More »

AZ issues revised efficacy figures for COVID-19 shot

AstraZeneca has issued revised efficacy figures from the US trial of its COVID-19 vaccine following a complaint from independent monitors that figures from an interim analysis published earlier this week were out of date. The new figures from AZ, which developed the vaccine in partnership with Oxford University, give an efficacy at preventing symptomatic COVID-19 …

AZ issues revised efficacy figures for COVID-19 shot Read More »

Cell-Mediated Therapies for Infectious Disease Summit

In the fight against emerging coronavirus variants and spike mutations, the need for long-lasting immunity is greater than ever. This is why the time is now to look beyond antibodies and capitalize on the long-term immune response of T cell therapies. The Cell-Mediated Therapies for Infectious Disease Summit is the first and only meeting focused on novel …

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Regulators questioned integrity of Pfizer/BioNTech vaccine, leaked files show

European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. As it conducted its analysis of the vaccine in December, the European Medicines Agency’s systems were targeted by unknown hackers. Following this, more than 40 megabytes of classified …

Regulators questioned integrity of Pfizer/BioNTech vaccine, leaked files show Read More »

EU probes low platelet safety issue with COVID-19 shots

EU regulators are reviewing reports of low blood platelets in patients who received any of the three approved COVID-19 vaccines from Pfizer/BioNTech, AstraZeneca and Moderna. The experts have also recommended a safety update on the label of Oxford University/AstraZeneca’s COVID-19 vaccine, which has been linked to anaphylactic reactions, in what has turned out to be …

EU probes low platelet safety issue with COVID-19 shots Read More »

J&J manufacturing delays hit US vaccine rollout

The rollout of the US COVID-19 vaccination programme slowed up this week because manufacturing delays mean no new doses of the recently approved Johnson & Johnson vaccine are available. The White House said on Tuesday that the government will distribute around 18.5 million doses of COVID-19 vaccines this week, fewer than last week because of …

J&J manufacturing delays hit US vaccine rollout Read More »

Austria safety officials suspend batch of AZ vaccines after death

Austrian health officials have withdrawn a batch of Oxford University/AstraZeneca’s COVID-19 vaccine after two cases of severe coagulation, one of which was fatal. Both patients were treated from the same batch, codenamed ABV 5300, in the district of Zwettl. In a statement the Austrian Federal Office for Safety in Health Care (BASG) said a 49 …

Austria safety officials suspend batch of AZ vaccines after death Read More »

Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan

Shots: Takeda has submitted an NDA to MHLW to import and distribute Moderna’s (mRNA-1273/ TAK-919) in Japan Takeda is conducting a P- I/II study assessing the safety and immunogenicity of two vaccinations of TAK-919 (100μg, given 28 days apart) in 200 participants aged ≥20yrs. followed through 12mos. after the second vaccination. Takeda has completed enrollment …

Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan Read More »

Budget 2021: Sunak focuses on vaccine development to restart economy

UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. The ongoing fight against COVID-19 was a top-line feature of the budget announcement, with an extra £1.65bn to ensure the …

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‘Vaccine, vaccine’: Dolly Parton urges Americans to get COVID-19 shots

Efforts to encourage US citizens to take their COVID-19 vaccines received a boost from country music legend Dolly Parton, who updated her hit song “Jolene” to pledge her support in a social media video showing her getting inoculated. Parton burst into a version of her hit, which she wrote and recorded in 1973, before receiving …

‘Vaccine, vaccine’: Dolly Parton urges Americans to get COVID-19 shots Read More »

Novavax in talks with FDA over quick approval for COVID-19 shot

Novavax hopes its COVID-19 vaccine could be filed in the US in the second quarter, following a potential approval from the UK regulator in the coming weeks. The timetable for approval from the FDA depends on whether the regulator accepts data from the company’s trial in the UK, which could set up a potential Emergency …

Novavax in talks with FDA over quick approval for COVID-19 shot Read More »

Genetic Vaccine Development for Infectious Diseases Summit

The COVID-19 pandemic brought life-changing disruptions to people around the world and has turned the typical vaccine R&D process on its head. A combination of urgent need, unprecedented investments, and advances in genetic engineering has allowed what was once mere speculation to become not only our reality, but our future. With pandemic vaccines now launching …

Genetic Vaccine Development for Infectious Diseases Summit Read More »

Data back use of AZ and Pfizer COVID-19 vaccines in older people

Both the Pfizer/BioNTech and Oxford University/AstraZeneca COVID-19 vaccines are highly effective in reducing COVID-19 infections among older people, according to an emerging study data. Data came from Public Health England, which has submitted findings of a real-world study for peer review. The article compares the rate of vaccination in symptomatic people aged over 70 years …

Data back use of AZ and Pfizer COVID-19 vaccines in older people Read More »

How advanced technology can streamline the COVID-19 vaccine rollout

Zebra Technologies healthcare lead Chris Sullivan discusses the COVID-19 vaccine rollout and how technology can streamline the process to combat new variants.  While the rollout of the COVID-19 vaccine has signified the first signs of light at the end of the tunnel, the reality is that this public health crisis is still far from over. …

How advanced technology can streamline the COVID-19 vaccine rollout Read More »

Johnson & Johnson Receives the US FDA’s EUA for COVID-19 Vaccine

Shots: The FDA has issued a EUA for a single-shot COVID-19 vaccine to prevent COVID-19 in individuals aged ≥18yrs. The company plans to file BLA to the US FDA in 2021 The EUA is based on a P-III ENSEMBLE study that demonstrated 85% efficacy in preventing severe disease across all regions and protect against COVID-19 …

Johnson & Johnson Receives the US FDA’s EUA for COVID-19 Vaccine Read More »

AZ sells stake in Moderna for more than $1billion

AstraZeneca has sold its stake in Moderna for more than $1 billion as the US biotech’s shares soared in value following its coronavirus vaccine breakthrough. The UK-based pharma has disposed of its 7.7% holding in the mRNA technology pioneer, The Times reported (behind paywall). Moderna was among the first companies to get a COVID-19 vaccine …

AZ sells stake in Moderna for more than $1billion Read More »

Altimmune begins trial of nasal vaccine for COVID-19

Pfizer/BioNTech’s mRNA vaccine against COVID is a technical marvel – but the ultra-cool temperatures required for storage and stability has been tricky to handle. Maryland, US-based company Altimmune is among the biotechs and research labs trying to find more convenient alternatives and believes a nasal vaccine spray that is stable at room temperature could be …

Altimmune begins trial of nasal vaccine for COVID-19 Read More »

Pfizer files tick-borne encephalitis shot with FDA

Pfizer may have been making headlines with the COVID vaccine it developed with BioNTech, but it’s not the only infectious disease the big pharma is targeting. In a statement, Pfizer said the FDA has granted a fast review for TicoVac tick-borne encephalitis (TBE) vaccine, to prevent the disease in individuals one year of age or …

Pfizer files tick-borne encephalitis shot with FDA Read More »

COVAX vaccine-sharing scheme delivers first COVID shots to Ghana

The first deliveries of vaccines from the World Health Organization-backed COVAX initiative, which aims to ensure access in low income countries,  has arrived. A shipment of 600,000 doses of the AstraZeneca/Oxford University vaccine to Accra in Ghana is seen as milestone for a scheme. It aims to address the imbalance that has seen the world’s …

COVAX vaccine-sharing scheme delivers first COVID shots to Ghana Read More »

FDA guidance allows fast updates of COVID-19 vaccines

The FDA has issued guidelines allowing for faster development of updated coronavirus vaccines, based on previously approved shots that have been tweaked to combat emerging variants of the SARS-CoV-2 virus. There is evidence that some of the emerging strains, particularly one that has emerged in South Africa, could be more resistant to vaccines developed to …

FDA guidance allows fast updates of COVID-19 vaccines Read More »

AZ to divert COVID-19 vaccines from global supply chain to meet EU target

AstraZeneca has said it will be able meet a target to deliver 180 million COVID-19 vaccines to the EU in the second quarter, by topping up the supply from its global production network. The company released a statement saying it will meet the EU’s targets by using its global supply chain to make up for …

AZ to divert COVID-19 vaccines from global supply chain to meet EU target Read More »

Sanofi and GSK Initiate P-II Study of their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine

Shots: The companies reported the initiation of a P-II dose-finding study assessing the safety, reactogenicity, and immunogenicity of two injections given 21 days apart in 720 adults aged ≥18yrs. The P-II study assesses the potential for refined antigen formulation to achieve an optimal immune response, including in older adults. If P-II results are positive, the …

Sanofi and GSK Initiate P-II Study of their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine Read More »

Sanofi/GSK restart COVID-19 vaccine trials after tweaking formulation

Sanofi and GlaxoSmithKline are restarting clinical development of their COVID-19 vaccine, which was delayed after hitting a snag late last year. In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults. At the time analysts said that this was likely due to an insufficient concentration of the …

Sanofi/GSK restart COVID-19 vaccine trials after tweaking formulation Read More »

Novavax provides 1.1 billion COVID shots to global vaccine drive

Novavax has signed a deal to provide 1.1 billion doses of its COVID-19 vaccine to the COVAX global initiative led by Gavi, the vaccine alliance, which aims to ensure fair access across the globe. There are growing concerns about the lack of COVID vaccines available to poorer countries. This week UK prime minister Boris Johnson …

Novavax provides 1.1 billion COVID shots to global vaccine drive Read More »

South African variant may cut response from Pfizer/BioNTech shot, study finds

The South African coronavirus variant may cut the effectiveness of Pfizer/BioNTech’s vaccine by around two thirds, according to a laboratory study. Researchers from the University of Texas Medical Branch based their findings on lab tests using SARS-CoV-2 coronaviruses that were genetically engineered to have the same mutations as those in the strain that is causing …

South African variant may cut response from Pfizer/BioNTech shot, study finds Read More »

Livi fights anti-vaxxers with digital patient messaging campaign

Digital health firm Livi is planning to step up its digital campaign to encourage people to get their COVID-19 vaccines in the UK, with messaging designed to provide accurate information to patients and counter social media messages from anti-vaxxer groups. Through its MJog platform the digital doctor service Livi is supporting the vaccine roll-out by …

Livi fights anti-vaxxers with digital patient messaging campaign Read More »

Europe orders another 200m doses of Pfizer/BioNTech COVID shot

The European Commission has ordered another 200 million doses of the Pfizer/BioNTech COVID-19 vaccine Comirnaty, bringing the bloc’s total order to 500 million doses. Under the latest deal the commission has an option for a further 100 million doses to be supplied to the 27 European member states. This new agreement is in addition to …

Europe orders another 200m doses of Pfizer/BioNTech COVID shot Read More »

AstraZeneca and Serum Institute of India’s COVID-19 Vaccine Receive WHO’s EUA to Prevent COVID-19

Shots: WHO has granted EUL to AZ’s vaccine for active immunization to prevent COVID-19 in individuals aged ≥18yrs., including those over 65yrs. EUL granted AZ and SII enabling global access to the vaccine The WHO’s SAGE recommended a dosing interval of 8-12wks. and also recommended the use of the vaccine in countries where new variants, …

AstraZeneca and Serum Institute of India’s COVID-19 Vaccine Receive WHO’s EUA to Prevent COVID-19 Read More »

Guinea declares Ebola epidemic following first deaths since 2016

Guinea has officially declared it is dealing with an Ebola epidemic, after at least three people died from the virus. The BBC reported that these first deaths from Ebola since 2016 were linked to the burial of a nurse, where four others fell ill with diarrhoea, vomiting and bleeding. Newly developed vaccines will be supplied …

Guinea declares Ebola epidemic following first deaths since 2016 Read More »

UK government mulls lockdown review as it hits 15m COVID vaccine target

More than 15 million people in the UK have had their first coronavirus vaccine, described as a ‘significant milestone’ by prime minister Boris Johnson. While the UK was slow to react to the first wave of the pandemic a year ago, it has mounted one of the fastest vaccination programmes in the world. The first …

UK government mulls lockdown review as it hits 15m COVID vaccine target Read More »

Early data back J&J and AC Immune’s Alzheimer’s jab

Shares in Swiss biotech AC Immune have risen sharply after it said a vaccine in development for Alzheimer’s disease (AD) hit the mark in a phase 1/2 trial.  ACI-35.030, partnered with Johnson & Johnson, is designed to stimulate the body to generate antibodies against tau protein, one of the factors though to play a role …

Early data back J&J and AC Immune’s Alzheimer’s jab Read More »

AZ’s next-generation COVID-19 vaccine could be ready in autumn

AstraZeneca is aiming to get a next-generation vaccine targeting emerging variants approved and into the arms of patients by the autumn, company representatives said in a press conference. Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said work has already begun to tweak the shot developed with Oxford University to combat the new variants, which …

AZ’s next-generation COVID-19 vaccine could be ready in autumn Read More »

EU finalises order for 300 million more Pfizer/BioNTech COVID-19 shots

The European Union has rubber-stamped its order for a further 300 million doses of Pfizer/BioNTech’s COVID-19 vaccine, according to press reports. Citing a European Commission spokesperson, Reuters reported the EU had finalised a preliminary contract for 300 million doses that was first announced a month ago. This is on top of the 300 million doses …

EU finalises order for 300 million more Pfizer/BioNTech COVID-19 shots Read More »

China approves Sinovac’s coronavirus vaccine

China’s national regulator has approved Sinovac Biotech’s COVID-19 vaccine for use by the general public. This is the second vaccine approved by China’s National Medical Products Administration (NMPA). Both of the vaccines, along with another experimental vaccine from Sinopharm, have been used in China’s vaccination programme. More than 31 million doses have been administered, mainly …

China approves Sinovac’s coronavirus vaccine Read More »

Daiichi Sankyo Signs an Outsourcing Agreement with AstraZeneca for COVID-19 Vaccine in Japan

Shots: Daiichi Sankyo signs an outsourcing Agreement to Manufacture AstraZeneca COVID-19 Vaccine AZD1222 in Japan Following the AstraZeneca’s agreement with the Japanese government to manufacture and supply COVID-19 vaccine, Daiichi Sankyo will use undiluted solutions to manufacture COVID-19 vaccines in the Japan including vial filling and packaging Additionally, Daiichi Sankyo will continue to work to …

Daiichi Sankyo Signs an Outsourcing Agreement with AstraZeneca for COVID-19 Vaccine in Japan Read More »

J&J asks FDA for emergence clearance for single-shot COVID-19 vaccine

Johnson & Johnson’s Janssen unit has filed its single dose COVID-19 vaccine candidate with the FDA, asking for an Emergency Use Authorization (EUA). The EUA will be based on the data from the phase 3 ENSEMBLE trial that Janssen announced last week. The European Medicines Agency (EMA) has already begun a rolling review of the …

J&J asks FDA for emergence clearance for single-shot COVID-19 vaccine Read More »

UK reaches 10 million landmark with COVID-19 vaccination programme

The UK has reached a major landmark with its COVID-19 vaccination programme, with more than 10 million people receiving their first shot. After almost a year of restrictions to prevent the virus spreading, there is now hope that normal life may begin to return as data collected separately in Israel showed that vaccination also helps …

UK reaches 10 million landmark with COVID-19 vaccination programme Read More »

Covaxx Initiates P-II Trial of UB-612 Against COVID-19 in Taiwan

Shots: The Taiwan Ministry of Health and Welfare granted conditional approval to initiate P-II trial of UB-612 in 3,850 subjects including adolescents, adults, and seniors across 11 medical centers and hospitals in Taiwan Additionally, Covaxx collaborated with UNMC to conduct clinical trials in the US, and with Dasa S.A. to conduct P-II/III study and distribute …

Covaxx Initiates P-II Trial of UB-612 Against COVID-19 in Taiwan Read More »

Clover and Dynavax Plan to Initiate P-II/III Trial for Adjuvanted COVID-19 Vaccine Candidate

Shots: Clover plans to initiate a global P-II/III efficacy trial with the S-Trimer COVID-19 vaccine candidate adjuvanted with CpG 1018 plus alum in the H1’2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021 Additionally, Clover discontinued their partnership with GSK to evaluate the S-Trimer vaccine candidate with GSK’s pandemic adjuvant …

Clover and Dynavax Plan to Initiate P-II/III Trial for Adjuvanted COVID-19 Vaccine Candidate Read More »

Gilead Signs an Option and License Agreement with Gritstone for HIV Vaccine

Shots: Gristone to receive $60M at closing, including $30M up front and a $30M as an equity investment at a premium and is eligible to receive up to ~$725M as option exercise payments and milestones along with royalties on sales of therapy Gilead will be in charge of conducting a P- I study for the …

Gilead Signs an Option and License Agreement with Gritstone for HIV Vaccine Read More »

AstraZeneca to supply nine million more vaccines to EU

The diplomatic row that broke out last week over the supply of AstraZeneca’s vaccine to Europe appears to have cooled after the UK pharma agreed to supply an extra nine million doses. At the end of last week, the European Commission was forced into an embarrassing U-Turn when it tried to impose restrictions on COVID-19 …

AstraZeneca to supply nine million more vaccines to EU Read More »

AZ has ‘constructive talks’ with EU leaders after vaccine row

AstraZeneca has said it has had “constructive talks” with European leaders in a bid to cool the row over vaccine supplies to the EU. The vaccine is expected to be approved by European regulators tomorrow, but this has been overshadowed by an announcement that the company will not be able to produce the 300 million …

AZ has ‘constructive talks’ with EU leaders after vaccine row Read More »

Sanofi steps in to boost supplies of Pfizer/BioNTech’s COVID shot

Sanofi has said it is to begin manufacturing the COVID-19 shot from Pfizer and BioNTech in a week when supplies are in the spotlight. The French pharma will use its production infrastructure to boost supplies of the vaccine and perform late-stage manufacturing to supply over 125 million doses to the EU. In a statement Sanofi …

Sanofi steps in to boost supplies of Pfizer/BioNTech’s COVID shot Read More »

US Merck axes two COVID-19 vaccines, focuses on therapies instead

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 …

US Merck axes two COVID-19 vaccines, focuses on therapies instead Read More »

Pfizer and BioNTech Signs an Agreement with Covax for Advance Purchase of Vaccine to Help Combat COVID-19

Shots: 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 …

Pfizer and BioNTech Signs an Agreement with Covax for Advance Purchase of Vaccine to Help Combat COVID-19 Read More »

Pfizer and BioNTech Signs an Agreement with Covax for Advance Purchase of Vaccine to Help Combat COVID-19

Shots: 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 …

Pfizer and BioNTech Signs an Agreement with Covax for Advance Purchase of Vaccine to Help Combat COVID-19 Read More »

Russia asks for “non-political” treatment of Sputnik V shot, then rules out US filing

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 …

Russia asks for “non-political” treatment of Sputnik V shot, then rules out US filing Read More »

ConserV Bioscience works on mutation-proof coronavirus shots with US lab

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 …

ConserV Bioscience works on mutation-proof coronavirus shots with US lab Read More »

One in 11 over-65s unwilling to take COVID-19 shot

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. Findings from part of the Heartline clinical study, sponsored by Johnson & Johnson …

One in 11 over-65s unwilling to take COVID-19 shot Read More »

COVID-19 vaccine supplies in spotlight as immunisation campaigns kick in

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 …

COVID-19 vaccine supplies in spotlight as immunisation campaigns kick in Read More »

J&J single-shot COVID-19 vaccine shows early promise

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 …

J&J single-shot COVID-19 vaccine shows early promise Read More »

YouTube teams up with providers, healthcare groups to combat health misinformation

The video-sharing giant is partnering with providers and groups, like Mayo Clinic and the American Public Health Association, to create evidence-based health content. YouTube has also added CVS Health’s former chief community health officer to lead those efforts.

IO Biotech raises $155m to develop breakthrough cancer vaccine

IO Biotech, an oncology specialist formed and backed by Denmark’s Novo Holdings, has raised €127 million ($155 million) to further develop its cancer vaccine technology that has boosted efficacy of PD-1 immunotherapy in early trials. The Series B fundraiser follows the FDA’s decision to grant Breakthrough Therapy designation last month for a combination of its …

IO Biotech raises $155m to develop breakthrough cancer vaccine Read More »

UK promises ‘uplift’ in COVID-19 vaccinations as crisis deepens

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 …

UK promises ‘uplift’ in COVID-19 vaccinations as crisis deepens Read More »

FDA and doctors warn against extending COVID-19 vaccine dose gap

Tinkering with the dosing schedule of COVID-19 vaccines runs a “significant risk” to public health, the FDA has warned in a statement after the UK announced plans to prioritise the first doses of two approved shots. The regulator made its comments after the UK announced a policy of stretching the gap between doses of the …

FDA and doctors warn against extending COVID-19 vaccine dose gap Read More »

Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine

Shots: Health Canada expedite the review of AstraZeneca’s COVID-19 vaccine after the vaccine received the UK’s MHRA approval for emergency use Following an agreement to supply 20M of doses for the Government of Canada, AstraZeneca seek out Health Canada’s clearance in Oct’2020, leading to data submission done on a rolling basis for accelerating the review …

Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine Read More »

Aurobindo Pharma Sign Agreement with COVAXX to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF

Shots: In the agreement, Aurobindo has obtained the exclusive rights to develop, manufacture & sell COVAXX’s UB-612 vaccine in India & UNICEF & also non-exclusive rights in other selected emerging & developing markets UB-612 is presently being assessed in P-I will be manufactured by Aurobindo in its Hyderabad facility has a manufacturing capacity of 220M …

Aurobindo Pharma Sign Agreement with COVAXX to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF Read More »

UK prepares for decision on AZ/Oxford vaccine as COVID cases soar

The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford University/AstraZeneca in the next few days. If the vaccine becomes available the UK will be able to step up its vaccination programme as large swathes of the country face draconian …

UK prepares for decision on AZ/Oxford vaccine as COVID cases soar Read More »

‘Highly likely’ BioNTech vaccine will work against new strain, says CEO

BioNTech CEO Ugur Sahin has said that it is “highly likely” the company’s COVID-19 vaccine will work against the more infectious strain circulating in the south east of England, although further studies will be needed. Sahin was addressing a news conference after the vaccine was approved by the European Union, three weeks after the shot …

‘Highly likely’ BioNTech vaccine will work against new strain, says CEO Read More »

Moderna and BioNTech – who are they?

Moderna and BioNTech, two rising stars in biotech, were in the limelight this year with their pioneering mRNA vaccines against COVID-19. Just who are these companies and who is behind them, asks Richard Staines. A year ago, the names Moderna and BioNTech were known mainly to those who followed biotech and pharma dealings. But the …

Moderna and BioNTech – who are they? Read More »

NHS pilots virtual assistant for flu jab bookings

More than 1,000 NHS patients have booked flu vaccinations using a virtual assistant as part of a pilot project in the south east of England. The pilot project, run in collaboration with GP practices in Buckinghamshire, Brent, and Greenwich, involved patients using the Ask NHS app, which is already used by more than 375,000 patients. …

NHS pilots virtual assistant for flu jab bookings Read More »

FDA aims for fast approval of Moderna’s COVID-19 shot after panel vote

The FDA is looking to quickly approve Moderna’s COVID-19 vaccine after it was unanimously backed by a panel of experts. Yesterday’s advisory panel meeting voted 20-0 in favour of approving Moderna’s vaccine and although the vote is non-binding, you could probably bet your house on the FDA backing the shot as it rarely goes against …

FDA aims for fast approval of Moderna’s COVID-19 shot after panel vote Read More »

Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

Shots: The VRBPAC voted 20-0, with one abstention that the benefits of the Moderna’s vaccine outweighed its risks for use in people aged ≥18yrs The recommendation is based on data analysis from the pivotal P-III clinical study that demonstrated 94.1% efficacy The US FDA’s committees provide non-binding recommendations. The FDA will take the VRBPAC’s recommendation …

Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19 Read More »

COVID-19 vaccine distribution: 4 ways providers can win with online self-scheduling

It’s been almost an entire year since COVID-19 changed life as we know it. The good news? A vaccine has finally arrived and is currently making its way to distribution sites across the United States—a significant milestone as the nation has seen more than 16 million cases to date, and more that 300,000 deaths. Because …

COVID-19 vaccine distribution: 4 ways providers can win with online self-scheduling Read More »

Trials of Valneva COVID-19 vaccine begin in UK

Trials of a fifth COVID-19 vaccine have begun in the UK, as IT issues threaten to delay the roll-out of the shot from Pfizer/BioNTech. France’s Valneva begun the phase 1/2 clinical study of the inactivated vaccine candidate VLA2001 in sites across the UK, supported by the National Institute for Health Research (NIHR). It is the …

Trials of Valneva COVID-19 vaccine begin in UK Read More »

Minervax raises €47.4m in Series B funding round for GBS shot

Denmark’s MinervaX has raised €47.4 million (around $56 million) in a Series B funding round to take its novel group B streptococcus (GBS) vaccine into mid-stage clinical trials. When and if the pandemic finally recedes there will still be an ongoing issue with a dearth of new antibiotics and a growing number of bacterial strains …

Minervax raises €47.4m in Series B funding round for GBS shot Read More »

Family doctors begin COVID-19 immunisation drive in UK

The roll-out of the biggest vaccination programme in the history of the UK’s NHS is gathering pace, as family doctors and their teams begin taking delivery of Pfizer/BioNTech’s COVID-19 shot. In a statement the NHS said that GP practices in more than 100 parts of the country are taking delivery of the vaccine today. Some …

Family doctors begin COVID-19 immunisation drive in UK Read More »

Sanofi/GSK trial woes delay a billion COVID-19 shots by nine months

Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinical development, prompting analysts to note this could delay delivery of potentially more than a billion shots globally by up to nine months. Interim results from a phase 1/2 clinical trial show the immune response from Sanofi/GSK’s vaccine produced a lower immune …

Sanofi/GSK trial woes delay a billion COVID-19 shots by nine months Read More »

FDA advisers vote in favour of Pfizer/BioNTech COVID-19 shot

Advisers to the FDA have voted in favour of approving Pfizer and BioNTech’s COVID-19 vaccine, with a near-unanimous backing from an expert committee. While the decision of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) is non-binding, the FDA seldom goes against the ruling of its advisers when making regulatory decisions. However has were …

FDA advisers vote in favour of Pfizer/BioNTech COVID-19 shot Read More »

QliqSOFT, CPSI to offer Covid-19 vaccine chatbot to community hospitals

The COVID-19 Vaccination Assistant will provide information about the new vaccines to help allay fears among the U.S. public. It will also help people schedule their vaccinations and connect them with rideshare services to make it to their appointment.

Coronavirus vaccine may have allergy warning in US, says expert

The US government’s coronavirus vaccine chief has said that Pfizer/BioNTech’s vaccine could carry a warning that it should be avoided by people who are prone to serious allergic reactions. Moncef Slaoui, co-head of the US government’s Operation Warp Speed COVID-19 vaccine programme, made the comments after the UK drugs regulator advised those with severe allergies …

Coronavirus vaccine may have allergy warning in US, says expert Read More »

CO2 Safety Monitors for Dry Ice Vaccination

Ormond Beach, FL – CO2Meter, Inc. has partnered with a national pharmacy chain to keep their customers and employees safe from the potential hazardous effects for CO2 exposure from the dry ice that is keeping the COVID-19 vaccines cold. A national pharmacy chain contacted CO2Meter on December 1st asking about devices to detect the release …

CO2 Safety Monitors for Dry Ice Vaccination Read More »

FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The gist of a briefing document published from FDA reviewers ahead of an expert advisory board …

FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel Read More »

Sinovac raises $515m to boost production of potential COVID-19 vaccine

China’s Sinovac has raised $515 million to increase its distribution and production capacity as clinical development of its potential coronavirus vaccine nears conclusion. According to press reports Sino Biopharmaceutical, a Hong Kong-listed generics firm, acquired a 15% stake in a subsidiary of Sinovac. Sinovac has a coronavirus vaccine in late-stage development, which is undergoing large-scale …

Sinovac raises $515m to boost production of potential COVID-19 vaccine Read More »

UK faces “V-Day” and largest ever vaccination programme

Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a clinical trial. Health secretary reportedly Matt Hancock came up with the wartime analogy to describe what will be the largest scale vaccination programme in the country’s history. The UK last …

UK faces “V-Day” and largest ever vaccination programme Read More »

Valneva accelerates Lyme disease vaccine R&D project with Pfizer

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. Subject to approval from regulators the vaccine specialist said it plans the trial known as VLA15-221 as a randomised, observer-blind phase 2 study including around 600 healthy people …

Valneva accelerates Lyme disease vaccine R&D project with Pfizer Read More »

Pfizer cut vaccine production targets because of raw material shortage – reports

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of …

Pfizer cut vaccine production targets because of raw material shortage – reports Read More »

The known unknowns of COVID-19 vaccines

News that COVID-19 vaccines are up to 95 per cent effective has scientists cautiously optimistic. But questions remain. “There’s a long list of things we don’t know,” says Maria Sundaram, a postdoctoral fellow at the Centre for Vaccine Preventable Diseases at the University of Toronto. Health Canada is currently reviewing early findings from Moderna, Pfizer/BioNTech …

The known unknowns of COVID-19 vaccines Read More »

Pfizer/BioNTech to deliver COVID-19 vaccine to UK after approval

Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world to approve it. As predicted by pharmaphorum, the regulator was able to move faster than its counterparts from the European Medicines Agency, who are also conducting a separate review of …

Pfizer/BioNTech to deliver COVID-19 vaccine to UK after approval Read More »

Pfizer/BioNTech say COVID-19 vaccine could be approved in Europe by year-end

Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year. The filing for a conditional marketing authorisation completed the rolling submission process that began on October 6. The companies initially filed the nonclinical data and other technical data, followed …

Pfizer/BioNTech say COVID-19 vaccine could be approved in Europe by year-end Read More »

Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study

Shots: The P-III COVE study demonstrated 94.1% efficacy against COVID-19 and 100% efficacy against severe COVID-19. The vaccine was well tolerated with no serious safety concerns identified to date Moderna plans to submit an EUA to the FDA & an application for CMA with the EMA and to progress with the rolling reviews, which have …

Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study Read More »

Vaccine nationalism, CDMO expansion, AMR and dual sourcing predicted in 2021

The new report looks ahead to a post-pandemic 2021 with pharma manufacturing capacity and payment structures shifting as new sourcing strategies emerge Amsterdam:  A new report from CPhI explores the potential implications in 2021 of impending vaccine approvals, a new administration in the White House and a return to dual supply chain strategies. The report …

Vaccine nationalism, CDMO expansion, AMR and dual sourcing predicted in 2021 Read More »

UK appoints COVID-19 vaccine rollout minister as country preps for launch

The UK has appointed Nadhim Zahawi as vaccine rollout minister as the country prepares for a potential approval of Pfizer/BioNTech’s ground-breaking COVID-19 vaccine. According to press reports, the UK’s drug regulator, the Medicines and Healthcare products Regulatory Authority (MHRA) could become one of the first bodies to approve the vaccine. According to the Financial Times, …

UK appoints COVID-19 vaccine rollout minister as country preps for launch Read More »

Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

Shots: Moderna amended its current supply agreement with the UK govt. for an additional 2M doses of mRNA-1273 against COVID-19. The UK govt. has now secured 7M doses of mRNA-1273 The agreement reflects Moderna’s commitment to making its vaccine available in multiple countries. Moderna ramp up its global manufacturing to be able to deliver ~500M …

Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine Read More »

AZ mulls trial of new COVID-19 vaccine dose as UK regulator begins review

AstraZeneca is to run an additional global trial to test its COVID-19 vaccine at a lower dosage, as the UK regulator begins to review trial data. The shot, known as AZD-1222, developed in partnership with Oxford University, has dominated the pharma news agenda this week after it hit efficacy targets but appeared short of rivals …

AZ mulls trial of new COVID-19 vaccine dose as UK regulator begins review Read More »

Brexit could hinder access to coronavirus vaccines, says pharma group

The UK’s pharma industry trade body has warned that Brexit could derail the government’s efforts to get coronavirus vaccines to the population, but welcomed other measures in this week’s spending review aimed at reviving the economy after the pandemic. In the build-up to chancellor Rishi Sunak’s announcement in the House of Commons, the Association of …

Brexit could hinder access to coronavirus vaccines, says pharma group Read More »

What, Us Worry

By KIM BELLARD 2020 has been an awful year.  Hurricanes, wildfires, murder hornets, unjustified shootings, a divisive Presidential election, and, of course, a pandemic.  Most of us are spending unprecedented amounts of time sheltering in place, millions have lost their jobs, the economy is sputtering, and over a quarter million of us didn’t survive to …

What, Us Worry Read More »

‘Mistake’ led to AZ’s more effective lower-dose COVID-19 shot

AstraZeneca’s research chief has said that the more effective dosing regimen of its coronavirus vaccine was discovered by accident. According to Reuters, the AstraZeneca development team made a minor mistake that made them realise they could significantly boost the success rate of the vaccine, codenamed AZD1222. Results announced earlier this week showed that by giving …

‘Mistake’ led to AZ’s more effective lower-dose COVID-19 shot Read More »

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Shots: Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and no hospitalizations/ severe cases of the disease were reported One dosing regimen showed an efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose …

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19 Read More »

AZ preps filings for COVID-19 jab, UK nears decision on Pfizer rival

AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective. AZ made the announcement as the UK regulator reportedly gears up to make a decision on the rival vaccine from Pfizer and BioNTech, ahead of counterparts in the US and Europe. Results from …

AZ preps filings for COVID-19 jab, UK nears decision on Pfizer rival Read More »

Pfizer/BioNTech prep US COVID-19 vaccine launch after emergency filing

Pfizer and BioNTech have filed for emergency use of their COVID-19 vaccine candidate in the US, paving the way for a launch before year-end. The announcement is no surprise as earlier this week, Pfizer’s CEO Albert Bourla said the company was preparing to file phase 3 data from the vaccine known as BNT162b2 with the …

Pfizer/BioNTech prep US COVID-19 vaccine launch after emergency filing Read More »

Pfizer prepares to file COVID-19 shot after reaching safety milestone

Pfizer is preparing to file its COVID-19 vaccine after a trial reached the safety milestone required by US regulators for emergency use, according to press reports. The company’s CEO Albert Bourla said that the company is preparing to submit its data to the FDA following last week’s announcement that the vaccine is more than 90% …

Pfizer prepares to file COVID-19 shot after reaching safety milestone Read More »

Pfizer begins US pilot delivery programme for COVID-19 vaccine

Pfizer has begun a pilot delivery programme in the US for its experimental COVID-19 vaccine, as the company seeks to overcome logistical challenges caused by its ultra-cold storage requirements. The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials. But it has a major drawback in that …

Pfizer begins US pilot delivery programme for COVID-19 vaccine Read More »

COVID-19 vaccine: More good news as Moderna releases results

Looks like more good news on the COVID-19 vaccine front. Dr. Fauci’s prediction that the Pfizer/BioNTech foreshadowed positive news for future vaccines appears to have come true. Stat News reports: The Moderna vaccine reduced the risk of Covid-19 infection by 94.5%. There were 95 cases of infection among patients who received placebo in the company’s …

COVID-19 vaccine: More good news as Moderna releases results Read More »

J&J begins trial of two-dose COVID-19 vaccine regimen

Johnson & Johnson has begun a second phase 3 trial of its potential COVID-19 vaccine, including sites in the UK, testing whether it works as a two-dose regimen. The company’s Janssen pharmaceuticals and vaccines unit has already begun the ENSEMBLE study testing the single-dose vaccine and plans to enrol up to 60,000 participants worldwide. It …

J&J begins trial of two-dose COVID-19 vaccine regimen Read More »

Hungary steps out of line with EU to order Russia’s COVID-19 vaccine

Hungary is to order a consignment of Russia’s Sputnik V COVID-19 vaccine, as the country struggles to contain the infection rate. According to press reports, the decision puts Hungary on “collision course” with the EU, which has not approved the vaccine or plans to review it either. The European Medicines Agency has announced rolling reviews …

Hungary steps out of line with EU to order Russia’s COVID-19 vaccine Read More »

GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine

Shots: Following the positive P-I results, Medicago has decided to launch the Phase 2/3 clinical trial with GSK’s pandemic adjuvant The study will evaluate the immunogenicity and safety profile of the chosen formulation and dosing regimen of CoVLP (two doses of 3.75µg combined with GSK’s adjuvant given 21 days apart) in healthy adults 18-64yrs. of …

GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine Read More »

EU orders 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine

The European Union has ordered 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine following this week’s landmark announcement that it was effective in more than 90% of patients. The companies said deliveries of an initial order of 200 million vaccines will be subject to approval by European regulators and are expected to start by the end …

EU orders 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine Read More »

J&J Resumes all Clinical Trial of its COVID-19 Vaccine in the EU

Shots: J&J has resumed recruitment, enrolment, and vaccination in all studies of its COVID-19 vaccine across the EU, after a temporary pause. Trials in the US, South Africa, and some Latin American countries are already ongoing Clinical trials to be resumed are the P-IIa studies in Germany, the Netherlands, and Spain and P-I/IIa study in …

J&J Resumes all Clinical Trial of its COVID-19 Vaccine in the EU Read More »

NHS set to roll out COVID-19 shot in New Year, says health secretary

The UK’s NHS is ready to start rolling out a coronavirus vaccine, likely beginning in the new year, according to health secretary Matt Hancock. In an interview with the BBC Hancock said that the vaccine could be available by Christmas, but he expected a mass roll out “in the first part of the new year”. …

NHS set to roll out COVID-19 shot in New Year, says health secretary Read More »

Divided Congress paves way for drug price reforms on Biden’s watch

Unless president Donald Trump is successful with legal challenges, Democratic rival Joe Biden looks to have won the White House in last week’s election but faces the challenges of a divided Congress when it comes to implementing important health policies. Making healthcare affordable is one of Biden’s goals as many Americans struggle to pay for …

Divided Congress paves way for drug price reforms on Biden’s watch Read More »

Positive news on a COVID-19 vaccine

Great news on progress for a COVID-19 vaccine from Pfizer. From their press release: Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis Analysis evaluated 94 confirmed cases of COVID-19 in trial participants Study enrolled 43,538 participants, …

Positive news on a COVID-19 vaccine Read More »

Pfizer/BioNTech say vaccine works in 90% of COVID-19 patients

As the death toll from COVID19 inexorably mounts, Pfizer and BioNTech have announced that their COVID-19 vaccine candidate is more than 90% effective at countering the disease in an interim analysis. The companies said they will be ready to file the vaccine with the FDA in the third week of November once they have enough …

Pfizer/BioNTech say vaccine works in 90% of COVID-19 patients Read More »

Drugs and vaccines may not swiftly end pandemic, says Merck & Co’s CEO

Merck & Co’s CEO Kenneth Frazier has warned that the drugs and vaccines in the pipeline to combat COVID-19 may not be enough to swiftly end the pandemic. Speaking to CNBC, Frazier said that the drugs and vaccines to treat COVID-19 are not a “silver bullet” solution to the pandemic, meaning people are likely to …

Drugs and vaccines may not swiftly end pandemic, says Merck & Co’s CEO Read More »

BCG – COVID-19 Hackathon Challenge Now Extended Through End of Year

A renewed interest in whether the BCG vaccine (for tuberculosis) could also have an application for COVID-19 has been on the rise, as evidenced by this recent Cell publication, the University of Exeter’s involvement in the BRACE Trial and ongoing general press coverage. Furthermore, the list of clinical trials focusing on this area is continuing to grow (and is available here). …

BCG – COVID-19 Hackathon Challenge Now Extended Through End of Year Read More »

Adult data back Merck’s challenger to Pfizer’s blockbuster Prevnar 13

Merck & Co has built more momentum behind its attempt to depose Pfizer’s blockbuster pneumococcal conjugate vaccine Prevnar 13, with two new phase 3 trials backing its rival shot V114. The two trials are both in adult subjects, a group that has been driving growth of Prevnar 13 in the last few years, and showed …

Adult data back Merck’s challenger to Pfizer’s blockbuster Prevnar 13 Read More »

AZ’s COVID-19 vaccine trial ready to resume – reports

AstraZeneca’s COVID-19 vaccine trial could be ready to resume this week in the US after a seven-week hiatus while the FDA completed its review of a serious illness, according to reports. Citing four sources, Reuters said that the FDA is about to allow the large-scale trial of the shot to resume after it was put …

AZ’s COVID-19 vaccine trial ready to resume – reports Read More »

UK government signs contract for COVID-19 challenge trial

The UK government has signed a contract to develop a controversial COVID-19 human challenge trial, where participants will be deliberately infected in a controlled environment with coronavirus to test whether a vaccine is effective. Contract research organisation (CRO) hVIVO, a subsidiary of Open Orphan, has signed the contract with the UK government to develop the …

UK government signs contract for COVID-19 challenge trial Read More »

Pfizer to wait until after election to file COVID-19 vaccine in US

Pfizer said it will wait until after the US election to file its COVID-19 vaccine with the US regulator, as it waits for important safety data to become available. The vaccine is being developed by Pfizer and development partner BioNTech and will wait until late November to make its application with the FDA. In a …

Pfizer to wait until after election to file COVID-19 vaccine in US Read More »

GSK Signs an Agreement with Vir Biotechnology to Develop Solutions for Coronaviruses

Shots: GSK will make equity investment to gain access to Vir’s technology of $250M, priced at $37.73 (a 10% premium to closing share price on March 27, 2020). The equity investment and collaboration will complete at the same time & are conditional upon customary conditions including regulatory review by appropriate regulatory agencies under Hart-Scott-Rodino Act …

GSK Signs an Agreement with Vir Biotechnology to Develop Solutions for Coronaviruses Read More »

BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2

Shots: The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work with the EMA’s CHMP to complete the rolling review process …

BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2 Read More »

Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab

The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZeneca and Oxford University. The announcement comes just days after the regulator said its CHMP scientific committee had begun to look at the first batch of …

Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab Read More »

Older people first to receive COVID-19 vaccine in UK, says government

As European regulators begin a rolling review of AstraZeneca’s COVID-19 vaccine, the focus in the UK has shifted to the government’s plans to distribute any vaccine that is deemed to be a safe and effective way of preventing the disease. According to weekend press reports a rollout of a vaccine could be just three months …

Older people first to receive COVID-19 vaccine in UK, says government Read More »

European regulators begin rolling review of AZ’s COVID-19 vaccine

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. It’s an historic announcement, bringing hope that the vaccine could be approved in the near future, although the European Medicines Agency did not say how long the process will take. …

European regulators begin rolling review of AZ’s COVID-19 vaccine Read More »

BCG-COVID 19 Hackathon: Task 1 winners announced, Task 2 – data scientists – we need you!

We’ve seen the scientific community come together time and again throughout the COVID-19 pandemic, and we’re thrilled to have been part of a hackathon bringing together data scientists, epidemiologists and partner organizations focusing on analysing the hypothesis of whether the tuberculosis (TB) vaccine – BCG – could reduce COVID-19 mortality. After the news hype mounted …

BCG-COVID 19 Hackathon: Task 1 winners announced, Task 2 – data scientists – we need you! Read More »

Pfizer/BioNTech say COVID-19 jab on track for approval by year-end

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. There are no vaccines approved for COVID-19 and governments across the world are striking deals with various manufacturers to get early …

Pfizer/BioNTech say COVID-19 jab on track for approval by year-end Read More »

Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

Shots: The companies have shared additional P-I safety and immunogenicity data from their ongoing US study of the BNT162b2 against SARS-CoV-2, which has advanced into P-II/III evaluation. Across all populations, BNT162b2 was well tolerated with mild to moderate fever in fewer than 20% of the participants In P-I study, BNT162b2 (@7days after the second dose …

Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020 Read More »

AstraZeneca Collaborates with mAbxience to Produce COVID-19 Vaccine in Latin America

Shots: mAbxience will produce ~200M + doses of AZD1222 and will supply it to all Latin American countries, except Brazil The company will produce API in its facility located in Garín (Argentina) and will send it to Mexico to complete the production and filling process. AstraZeneca will transfer its technology to the Garín plant shortly, …

AstraZeneca Collaborates with mAbxience to Produce COVID-19 Vaccine in Latin America Read More »

EC Concludes Exploratory Talks with J&J to Supply 200M Doses of COVID-19 Vaccine

Shots: The EC has the contractual framework in place to purchase the initial 200M doses on behalf of all EU Member States once the vaccine has proven safe and effective. The agreement includes an option to purchase up to an additional 200M dose If approved, the EC expects to facilitate a process for the allocation …

EC Concludes Exploratory Talks with J&J to Supply 200M Doses of COVID-19 Vaccine Read More »

AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021

Shots: AstraZeneca collaborates with the Mexican and Argentinean governments to initially produce 150M doses of the vaccine and eventually make at least 400M for distribution throughout the region The price for the vaccine is not final but it is expected not to exceed $4/ dose. The vaccine will initially supply to all Latin American countries …

AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021 Read More »

Scepticism as Russia claims coronavirus vaccine breakthrough with Sputnik V

Russia has become the first country in the world to approve a coronavirus vaccine, amid scepticism from international experts who have been unable to review or verify clinical data from the jab called ‘Sputnik V’. According to press reports the vaccine has been tested on one of President Vladimir Putin’s daughters. But World Health Organization …

Scepticism as Russia claims coronavirus vaccine breakthrough with Sputnik V Read More »

Johnson & Johnson Signs an Agreement with the US Government to Supply 100M Doses of COVID-19 Vaccine Worth ~$1B

Shots: The US government will pay over $1B for 100M doses of its potential COVID-19 vaccine, Ad26.COV2.S, for use in the US following the US FDA’s EUA The government may also purchase additional 200M doses of Ad26.COV2.S under a subsequent agreement. The company is evaluating one- and two-dose regimens, in its clinical program for the global …

Johnson & Johnson Signs an Agreement with the US Government to Supply 100M Doses of COVID-19 Vaccine Worth ~$1B Read More »

Insights+ KOL Articles: The New Normal and Covid-19 Vaccine Development

Since the virus outbreak in China, all eyes are on the most awaited Covid-19 vaccine offering a glimmer of hope. Abide by social distancing, wearing a mask, and frequent hand washing – until we have a vaccine. This new mantra amidst all misery has created hope in the hearts of many. We have to accept …

Insights+ KOL Articles: The New Normal and Covid-19 Vaccine Development Read More »

Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine

Shots: The US government will provide ~$2.1B to support the development of the vaccine, including clinical trials with some amount to be used for ramping up the manufacturing and delivery of an initial 100M dose of the vaccine The US government has an option to supply an additional 500M dose and helps the government’s Operation …

Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine Read More »

US pays $2.1bn to Sanofi/GSK for 100 million doses of COVID-19 vaccine

The US government has selected a potential vaccine from Sanofi and GlaxoSmithKline for its Operation Warp Speed COVID-19 vaccine development initiative, committing up to $2.1 billion for an initial 100 million doses. The collaborative effort with the US government will accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine. Developed by Sanofi in …

US pays $2.1bn to Sanofi/GSK for 100 million doses of COVID-19 vaccine Read More »

Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Shots: The two global companies will supply up to ~60M doses of a vaccine to the UK’s government to combat COVID-19 Sanofi leads the clinical development and registration of the vaccine and expects a P-I/II study to be initiated in Sept’2020, followed by a P-III study by the end of 2020. Additionally, the companies are …

Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine Read More »

Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Shots: The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2, 30µg dose level in a 2 dose regimen) from their BNT162 mRNA-based vaccine program against SARS-CoV-2 The P-II/III study follows the US FDA’s guidance on clinical trial design, will evaluate up to 30,000 participants in a ratio (1:1)  aged 18 …

Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19 Read More »

Moderna gets further $472m as expanded phase 3 COVID-19 trial begins

A US government agency is to give a further $472 million to biotech Moderna, after it announced plans to expand a phase 3 trial for its potential COVID-19 jab. The latest funding from the Biomedical Advanced Research and Development Authority follows a tranche worth $483 million, awarded to kick-start development of Moderna’s mRNA-based vaccine codenamed …

Moderna gets further $472m as expanded phase 3 COVID-19 trial begins Read More »

UK announces COVID-19 vaccine deals with BioNTech/Pfizer and Valneva

The UK has secured 90 million doses of two different COVID-19 vaccines from BioNTech/Pfizer and Valneva, with an option of 40 million doses if they check out in trials.  There is no approved COVID-19 vaccine, but governments across the world are busy signing deals with developers to gain access should trial results check out.  The announcements came as the scientific community held …

UK announces COVID-19 vaccine deals with BioNTech/Pfizer and Valneva Read More »

Call for COVID-19 ‘challenge trial’ ahead of AstraZeneca vaccine readout

Press reports suggest that there is good news about AstraZeneca and Oxford University’s COVID-19 vaccine due from an early stage trial in the coming days – but the focus is moving on how to get the in-depth safety and efficacy results needed to get the jab formally approved.  According to the press reports, the phase …

Call for COVID-19 ‘challenge trial’ ahead of AstraZeneca vaccine readout Read More »

No Approved Drug or Chemical For Prevention and Treatment of Coronavirus

The health authorities have time and again requested people not to take any drug or medicines by themselves in an attempt to cure coronavirus. When something is available for the treatment of COVID-19, it will be publicly announced by the World Health Organization (WHO). The WHO is already coordinating with the pharmaceutical companies and researchers …

No Approved Drug or Chemical For Prevention and Treatment of Coronavirus Read More »