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”.
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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.
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Second shots of coronavirus vaccine could be delayed even further amid growing evidence that spacing out the doses improves their effectiveness.
The NHS vaccination programme aims to immunise about 14 million people at greatest risk of Covid by mid-February with second doses due to be given up to 12 weeks later.
Australia’s chief medical officer Professor Paul Kelly and infectious diseases experts have defended securing 54m doses of a Covid-19 vaccine made by Oxford University and pharmaceutical company AstraZeneca, amid concerns the vaccine will not be effective enough to achieve herd immunity.
The president of the Australian and New Zealand Society for Immunology, Prof Stephen Turner, told Nine media that Australia should halt the AstraZeneca vaccine rollout because it has “lower efficacy”.
The choice we have is not whether to use one or the other, it is whether to use what we have
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.
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The European medicines Agency (EMA) said this morning it has received a marketing application from AstraZeneca for its COVID-19 vaccine, already rolling out in the UK, and could give it the go-ahead later this month.
The filing for conditional marketing approval is scheduled for review by the EMA’s CHMP human medicine committee at a meeting on 29 January, and if all goes well it could be authorised on that day, according to the regulator.
The European Commission will then fast-track its decision-making process, says the EMA, with a view to granting a conditional marketing authorisation “within days”, a timeframe which was welcomed by Commission President Ursula von der Leyen.
AZ’s AZD1222 shot – which was developed with Oxford University – was cleared by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on 30 December, and since then it has also been given emergency approval in several other countries including India.
The filing comes as the EU is facing criticism for the slow roll-out of its coronavirus vaccination programme as infection rates soar in the 27 member states.
While individual EU countries make the decisions about who to vaccinate, the Commission is coordinating the acquisition and allocation of supplies, and there have been complaints the process is taking too long.
The US and Britain have both vaccinated 1%-2% of their populations, according to an Economist report citing figures from the Our World in Data website, while Israel is leading the field at 16%. In contrast, Germany has managed just 0.4%, France didn’t cross the 1,000 threshold until 4 January, and the Netherlands only started vaccinating until 6 January.
So far the EMA has conditionally approved two coronavirus vaccines – Pfizer/BioNTech’s Comirnaty last month and Moderna’s candidate last week – and swift approval of the AZ vaccine should allow an acceleration in vaccination rates in the EU.
As it stands, the UK has vaccinated more people than the entirety of the EU combined, with the latest government figures indicating 2.3 million people have now received the first of two required doses, saying it plans to immunise all adults in the country by the autumn.
So far the effect of vaccination is imperceptible, however, as the UK recorded more than 46,000 new cases of COVID-19 yesterday, and 529 deaths, with NHS capacity creaking under the weight of over 32,000 people hospitalised with the infection.
The EU has 400 million doses of the AZ vaccine on order, part of a procurement programme that so far extends to 2.3 billion doses.
Last week the Commission said it intended to order an additional 200 million doses of the BioNTech/Pfizer, with the option to acquire another 100 million doses, taking its total to 600 million doses.
It has also agreed deals for the supply of 160 million doses of the Moderna shot, 400 million apiece for candidates in testing at Johnson & Johnson and CureVac, and 300 million of a Sanofi/GlaxoSmithKline candidate that has been delayed by clinical trial snags.
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COVID-19 has laid bare racial disparities in the United States health system. For example, COVID-19 cases among Native Hawaiian / Pacific Islanders are up to 2.5 times higher as compared to whites. Similarly, the rate of COVID-19 related deaths among Black Americans and American Indian/Alaskan Natives are twice as high as whites. A recent PhRMA paper finds that gaps in information on race, ethnicity and health are barriers to achieving health equity for many groups.
One in five Israelis have been given first doses of coronavirus vaccines, roughly ten times higher than the UK and US, with the country aiming to have inoculated all eligible age groups within two months.
Israel’s lighting-fast vaccine campaign had been expected to slow down this week as the first batches of Pfizer/BioNTech doses ran low.
As part of PhRMA’s continuing work to address health inequities, we are partnering with researchers to study hotspots of COVID-19 and chronic disease inequities in New York state. Reports this summer show that boroughs in New York City with the lowest per-person income and lowest number of employer establishments had the highest COVID-19 mortality rates.
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.
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EU leaders are to hold a pandemic video summit on 21 January after the bloc said it had reached a deal with Pfizer and BioNTech for 300m more doses of their Covid-19 vaccine, giving the EU nearly half the firms’ global output for 2021.
The move raised hopes for speedier inoculation across the continent as the European regulator, which this week approved the Moderna shot, said it would authorise six doses from each vial of the BioNTech/Pfizer vaccine, increasing available jabs by 20%.
The Pfizer/BioNTech Covid jab is an mRNA vaccine. Essentially, mRNA is a molecule used by living cells to turn the gene sequences in DNA into the proteins that are the building blocks of all their fundamental structures. A segment of DNA gets copied (“transcribed”) into a piece of mRNA, which in turn gets “read” by the cell’s tools for synthesising proteins.
The Moderna coronavirus vaccine has been approved for use in the UK.
The jab is the third to be given the green light by the Medicines and Healthcare products Regulatory Agency (MHRA), along with the Covid-19 vaccines from Pfizer/BioNTech and Oxford/AstraZeneca. But unlike the previous jabs, the Moderna vaccine will not be available for use straight away, with the first doses not expected to arrive until the spring.
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.”
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A third Covid vaccine is likely to be approved for use in Britain next week but it will not be available until April because the UK is no longer part of the EU.
Britain has ordered 7m doses of the Moderna vaccine, which has been approved by regulators in the EU and US. But UK authorisation will not help the government towards its goal of vaccinating the most vulnerable by mid-February.
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.
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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).
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Everything now hinges on a vaccine: how many more Britons die, whether the NHS finally breaks, how long the UK stays locked down. All depends on how fast the country can get vaccinated against this plague. Yet we’re in this position in large part because of government failure. When the prime minister imposes lockdowns late and with a sulky grumble; when we haven’t fixed our £22bn test-and-trace system (which, by the way, now bankrolls more outside consultants and contractors than the Treasury has actual civil servants); and when the Dominics and Stanleys are allowed to carry on as if rules are for the little people. If Boris Johnson blunts every political instrument he can lay his pale and meaty hands on, pretty soon a syringe is the only resort.
Vaccines were always going to be how the world limped out of this pandemic; but as Taiwan and New Zealand show, even without inoculation it is possible to drive the number of Covid cases significantly down. Compare their record with the UK – which is on course to hit 100,000 Covid-related deaths before January is out, and where a staggering one in 30 Londoners is today infected. The lecterns from which Johnson and his top advisers gave their press conference this week read “Stay Home. Protect the NHS. Save Lives” – exactly as they did at the start of all this last March, as if to confirm how little progress they have made in almost a year.
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
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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 .
The UK vaccine minister, Nadhim Zahawi, has pledged a “massive uplift” in the number of coronavirus vaccinations carried out this week as he said reaching the government’s target of 13.9m jabs offered by February would be “challenging”.
Zahawi, the minister responsible for the vaccine rollout, 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 government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19 in the UK. The list is:
There is no scientific evidence for a delay of more than six weeks in administering the second dose of the Pfizer/BioNTech vaccine against Covid, say experts from the World Health Organization.
The UK is planning to postpone giving the second dose of both the Pfizer/BioNTech and the Oxford/AstraZeneca vaccines by up to 12 weeks – twice the length of time for which there is data, according to the WHO.
The UK is setting the pace around the world in the approval and use of Covid vaccines but, while other countries watch intently, not all are yet prepared to embrace what looks like public health pragmatism rather than strict adherence to evidence.
Britain is the first country in the world to approve and use the Oxford/AstraZeneca vaccine, just as it was first with Pfizer/BioNTech’s. In a further trailblazing decision, it is giving everyone a first shot of either of those vaccines, with the second shot delayed to 12 weeks afterwards instead of the three- or four-week interval in the trials.
The biggest vaccination programme in the UK’s history will receive a major boost on Monday, with the first use of the Oxford/AstraZeneca Covid vaccine. We answer some key questions around how it will be deployed in England.
- Why is Britain delaying second doses of vaccine?
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People in Britain are set to get their first shots of the Oxford/AstraZeneca vaccine on Monday, with millions of doses being given over the next few months. The mass vaccination of the UK’s population should bring an end to the country’s Covid-19 misery, but how long will it take for this immunisation programme to make a difference to our lives – and what will be the first signs that salvation is on the way?
These key issues will be anxiously pursued as the battle against Covid proceeds and daily cases involving the new virus variant continue to spread. However, scientists have warned that simply waiting for a reduction in new cases it not the way to tell whether the vaccine is starting to have an impact.
The Oxford/AstraZeneca vaccine is central to the government’s plans for ending social distancing in the UK and returning to some sort of normality. It has invested in seven different vaccines, but the biggest order is for 100m doses of the AstraZeneca jab, most of which will be manufactured in the UK. While the prime minister was jubilant that the UK was first in the world to approve the Pfizer/BioNTech vaccine, he is now able to claim a British triumph. More to the point is the ease of use of the AstraZeneca vaccine. Unlike Pfizer’s, it does not have to be kept in the long term at -70C. Pfizer’s vaccine can be stored in a fridge for five days, but AstraZeneca’s can be kept for months at fridge temperature, which is 2-8C and will be easy to take to care homes to administer to residents, the first priority group for vaccination.
The manufacturer of the Pfizer/BioNTech vaccine has said its efficacy has only been assessed for two doses given three weeks apart. Therefore the idea that a single dose will be protective beyond three weeks is speculative (Covid vaccine: chief medical officers defend rescheduling of second doses, 31 December). It would be truly tragic to vaccinate millions of recipients with the Pfizer/ BioNTech vaccine (at considerable effort and financial cost) with a twelve-week gap between doses if this doesn’t give them protection.
It is worth noting that there is likely to be a correlation between the antibody response and protection from infection. Therefore volunteers who have already completed two doses could be asked to give a small sample of blood to check the level of neutralising antibodies present four weeks from the first dose. Recipients whose second dose has been postponed after 4 January could give a similar sample from 11 January onwards to check their levels at the four-week point. A relatively small number of volunteers (perhaps 20 or 30 in each group) might settle this.
BioNtech has criticised the EU’s failure to order more doses of its coronavirus vaccine, saying it is now racing with its US partner Pfizer to boost production amid fears of a European “gap” left by the lack of other approved vaccines.
The Pfizer/BioNTech vaccine was the first to be approved by the bloc late last month, after being accepted by the UK, Canada and the US. They and other countries have also since approved the Moderna or Oxford/AstraZeneca vaccine, leaving the EU trailing behind.
It’s a pragmatic solution to an incredibly urgent problem – how to immunise very large numbers of people at risk from a rampaging variant of Covid-19 in the shortest possible time. The answer that government advisers have come up with is to give them all – more than 20 million of them – a single shot of the Oxford/AstraZeneca vaccine so that they have some protection and postpone the second dose to three months afterwards, when hopefully there will be plenty of vaccine available for boosters.
Most of the sprawling industrial estate on the edge of Wrexham was quiet. There was little sign of activity at the engineering firms or in the self-storage units or greasy spoon cafes.
But behind the wire fence of the Wockhardt UK plant, the laboratories and production lines were buzzing as scores of staff worked on the final part of the manufacture of the Oxford/AstraZeneca vaccine.
The UK has approved AstraZeneca and Oxford University’s COVID-19 vaccine AZD1222 in another significant step forward in the fight against the pandemic, with first doses due to be administered on Monday.
The UK government has already ordered 100 million doses of the adenovirus-based shot, enough to vaccinate 50 million people, adding to the 40 million dose order of the Pfizer/BioNTech shot – now known as Comirnaty – that was approved earlier this month.
The UK is the first country to approved AZD1222, and AZ says it is preparing to provide “millions of doses” in the first quarter of 2021, while building capacity for three billion doses for delivery worldwide by the end of the coming year.
The emergency approval comes as millions more people in the UK are facing tighter lockdown restrictions after another daily record of more than 53,000 confirmed new coronavirus cases yesterday.
Health Secretary Matt Hancock warned that while the rollout of AZD1222 brings forward the end of the pandemic, mass vaccination will take time and people should “hold their nerve” to avoid swamping the NHS in the first few months of 2021.
He told the BBC this morning that he now has “a high degree of confidence that we can be out of this by the spring.”
The Joint Committee on Vaccine and Immunisation (JCVI) has set out priority groups who will receive the vaccine, and as with the Pfizer/BioNTech jab first in line will be the over-80s and health and social care workers. So far, more than 600,000 people have received Comirnaty since dosing started on 9 December.
AZ chief executive Pascal Soriot said that millions of doses of AZD1222 have already been produced and are being filled, ready to ramp up supply as the UK immunisation programme gathers pace.
Soriot confirmed that AZ should be able to provide enough vaccine to meet the UK government’s target of a million doses per week “very rapidly” with the first doses due to be delivered to clinics “today or tomorrow.”
He also said that AZD1222 provides a reasonable level of protection from the coronavirus after a single dose, and as the second dose only needs to be given within 12 weeks, that provides an opportunity to immunise more people, more quickly.
In turn, that should start to reduce mortality and hospitalisation from COVID-19 and ease pressure from the NHS as cases continue to surge.
The AZ vaccine can also be stored, transported and handled at normal refrigerated conditions for at least six months making it more suitable for delivery to parts of the world with less sophisticated healthcare systems than the Pfizer/BioNTech shot, which requires colder storage.
Soriot also reiterated his view that AZD1222 should provide protection against the new, more transmissible strain of the SARS-CoV-2 virus that causes COVID-19.
The first case of that has now been identified in the US, along with dozens of other countries, but new research suggests that while it is easier to transmit it isn’t any more likely to cause severe disease.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved two full doses of AZD122, which has a top-line protective efficacy of 62%, as it decided there wasn’t enough data on a half dose/full dose combination that seemed to be more effective in trials with 90% protection rate.
The British Medical Association’s council chair Dr Chaand Nagpaul, welcomed the approval, but warned the rollout will require a massive step up in immunisation capacity.
“It is now crucial that supplies of this vaccine are given to as many GP practice sites and hospital hubs as possible and that this happens as quickly as possible so that we can begin vaccination en masse,” he said.
“We need to see a step change in distribution so that doctors can protect their patients and communities, beginning with those most at risk, and crucially this must include health and social care workers as they confront the virus on the front line.”
The BMA has previously said it is concerned about patchy access to the Pfizer/BioNTech vaccine by healthcare workers across the country.
EU orders another 100m doses of Comirnaty
The EMA is still reviewing the AZ vaccine, but yesterday exercised an option to acquire another 100 million doses of Comirnaty for distribution in the EU in 2021, taking the tally to 300 million doses.
Pfizer and BioNTech say they will be able to meet that order, agreed just two days after the first vaccinations against COVID-19 started in EU member states. The companies have previously said they will be able to supply up to 1.3 billion doses worldwide by the end of 2021.
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2020 has been the most remarkable year for the global financial markets. After the Covid-19 pandemic triggered the worst crash in a generation, unprecedented stimulus measures and vaccine breakthroughs have sent stocks roaring back to record highs.
In a year in which at least 1.7 million people died from coronavirus and unemployment soared in a global recession, world stock markets are ending 2020 up 13% – despite the latest surge in cases forcing further lockdowns this winter.
NHS England’s chief executive Sir Simon Stevens has said that all vulnerable people over the age of 50 will be offered a COVID-19 vaccine by “late spring” in a message to healthcare workers.
The prediction comes after the NHS announced on Christmas Eve that more than half a million people had received the Pfizer/BioNTech shot approved in early December, but will depend on additional vaccine supplies coming “on stream”, according to Stevens.
There are around 25 million people classed as vulnerable due to their age or health conditions, and hitting that target will likely rely on the much-anticipated approval of the AstraZeneca/University of Oxford COVID-19 vaccine, said to be coming this week.
The UK has ordered 100 million doses of the AZ vaccine, which unlike the Pfizer/BioNTech shot can be stored and transported at normal temperatures, making it easier to distribute. Around 40 million doses are due to be delivered before the end of March. A third shot from Moderna isn’t expected to be available in the UK until well into next year.
The Pfizer/BioNTech vaccine – which was approved by the EU last week – is being delivered via a network of more than 80 hospital hubs and over 500 GP-led vaccination centres, as well as in care homes in the UK.
That will likely have to be expanded even further if the AZ vaccine is approved and as the immunisation programme gathers pace.
Stevens’ forecast – delivered to staff at a vacciination centre – came alongside a warning that NHS workers are “back in the eye of the storm”, with the number of coronavirus patients in hospitals higher than at the peak of the first wave.
There were around 20,500 hospitalised cases as of this morning, above a peak of just under 19,000 as the first wave hit in April. The UK also recorded a record number of lab-confirmed new cases yesterday at more than 41,000, although that figures reflects a higher level of testing nationally.
At the same time, the new, more transmissible variant of SARS-CoV-2 that was first identified in the UK has been detected in more than 20 other countries around the world, including several EU member states, India, Canada, Japan and Hong Kong.
The leading vaccine developers have said there is no reason their shots will not work against the new variant.
So far there is little evidence of “anti-vaxxer” resistance to the vaccine in the UK. However, in Spain – where more than a quarter of people said they would not take the vaccine in a recent survey – the health ministry has suggested it will set up a registry of people who refuse to be vaccinated and share it with other EU members.
The European Commission has said it expects to deliver 200 million doses of the Pfizer/BioNTech vaccine to EU countries by September 2021.
Novavax vaccine starts US phase 3
Meanwhile, another COVID-19 vaccine has entered the late-stage testing phase in North America. US biotech Novavax has started a phase 3 trial of its recombinant protein-based shot NVX-CoV2373 in the US and Mexico, adding to an ongoing phase 3 trial that started in the UK that is due to read out next year.
The UK government has already signed an agreement with the US biotech to buy 60 million doses of the vaccine in August if trials work out.
The post Vulnerable should all get COVID-19 shot before summer, says NHS chief appeared first on .
Frontline NHS staff have been denied the Pfizer/BioNTech vaccine, leaving doctors alarmed and “scrabbling” to get immunised.
A new survey reveals that almost two-thirds of medics who responded to it have still not had the vaccine, half believe its delivery to the NHS frontline has been “ad hoc” and a third have no idea when they will be offered it. They fear the government’s decision to prioritise over-80s and care home staff above health workers has left them at risk of catching the disease, especially given the emergence of the coronavirus variant, which is 70% more transmissable.
British scientists are trialling a new drug that could prevent someone who has been exposed to coronavirus from going on to develop the disease Covid-19, which experts say could save many lives.
The antibody therapy would confer instant immunity against the disease and could be given as an emergency treatment to hospital inpatients and care home residents to help contain outbreaks.
The chief executive of the German pharmaceutical company BioNTech has said he is confident its coronavirus vaccine works against the new UK variant, but that further studies are need to be certain.
Uğur Şahin told a press conference that his team had been working on trying to find out whether the vaccine worked on the UK variant or whether it would be necessary to adapt it. Results would be known within two weeks, he said.
The Pfizer/BioNTech Covid jab is an mRNA vaccine. Essentially, mRNA is a molecule used by living cells to turn the gene sequences in DNA into the proteins that are the building blocks of all their fundamental structures. A segment of DNA gets copied (“transcribed”) into a piece of mRNA, which in turn gets “read” by the cell’s tools for synthesising proteins.
The government was operating an illegal “buy British” policy when it signed contracts with a small UK firm to supply Covid antibody tests, claim lawyers who have filed a case against the health secretary.
The Good Law Project said there were a number of other companies in a better position to supply antibody tests in June and August, when the Department of Health and Social Care (DHSC) agreed deals worth up to £80m with Abingdon Health without going out to tender.
Two weeks ago, Vicore reported mid-stage data showing that its lead drug C21 could boost the benefit of steroid therapy in treating COVID-19. Now, it has new data from the trial to back up that promise, and says the drug could act as a “complement” to coronavirus vaccines.
The Swedish biotech’s chief executive Carl-Johan Dalsgaarl said on a conference call that the extended analysis from the ATTRACT trial reinforced earlier data showing that C21 reduced the need for supplemental oxygen and restored lung function in hospitalised COVID-19 patients.
The company is now planning to start a large phase 2/3 trial in the second quarter of next year to try to reproduce the findings in moderate to severe disease requiring hospitalisation – a group where other drugs including Eli Lilly’s antibody bamlanivimab and Gilead’s Veklury (remdesivir) haven’t shown a benefit.
C21 (also known as VP01) is an oral angiotensin II type two receptor (AT2R) agonist that is also being developed for idiopathic pulmonary fibrosis (IPF) and lung complications of systemic sclerosis (SSc), as well as being repurposed for COVID-19.
Two weeks ago, Vicore reported that giving C21 to coronavirus patients reduced the need for oxygen therapy by 40% after seven days’ dosing, which approached but didn’t quite reach statistical significance.
Now, with additional follow-up, it says that at day eight after start of treatment the risk reduction is 57%, which reached significance threshold with a statistical p value of 0.014, below the generally acknowledged threshold of 0.05.
ATTRACT recruited 106 patients, 61 on the study drug and 55 on placebo, who had been hospitalised and on testing showed evidence of severe inflammation – a situation that predicts a poor prognosis – and in almost all cases were on steroid therapy, which has been proven to cut deaths in COVID-19.
At the end of the trial, the effect was even more pronounced with only one patient in the C21 group still needing oxygen…compared to 11 in the placebo group,” Dalsgaarl said.
There was also a statistically significant reduction in C-reactive protein, a marker of inflammation – although only in the group needing oxygen and not the entire C2 group – as well as trends towards a reduce need for mechanical ventilation and a lower death rate.
Vicore now plans to follow up patients for 24 weeks to see if the drug can have an impact on longer term lung injury.
C21 is thought to normalise gas exchange in the lung cells, restoring their function, according to Dalsgaarl.
“The critical incident in COVID-19 that makes this disease different to a common cold is the progression to the distal airways with respiratory distress and subsequent need for oxygen supplementation”, said Dalsgaard.
“Our data clearly show that C21 can restore lung function on top of steroids and normalise gas exchange.”
Moreover, with a new strain in the UK raising fears that the virus may start to elude current therapies, there could be advantages for a drug that bypasses the virus to work on the lung itself.
Vicore is also intrigued by the possibility of using C21 as an oral treatment that can be used as an outpatient therapy for milder disease, potentially reducing the need for hospitalisation, that could be used in conjunction with immunisation programmes.
It would like to look at that in a second phase 2/3 trial but acknowledges it may need a larger partner to take that forward.
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As the world has grappled with the current pandemic, there has been increased focus on biopharmaceutical manufacturing and its global supply chain. Many wondered whether the biopharmaceutical industry could ensure continued and uninterrupted supply of innovative medicines relied on by so many Americans, as well as develop and supply new treatments and vaccines to address the pandemic. We are nearly a year into this public health crisis, and the biopharmaceutical manufacturing industry has stepped up to help beat COVID-19 in more ways than one. A new report from TEConomy Partners takes a closer look at what makes the U.S. biopharmaceutical manufacturing industry so globally competitive. While highlighting U.S. leadership, the report also makes clear the critical steps needed to secure that leadership: addressing the gaps in infrastructure investments, as well as investing in the growth of a STEM workforce.
As expected, the FDA has moved swiftly ahead with emergency approval of Moderna’s COVID-19 vaccine after a positive assessment at its vaccines advisory committee.
The authorisation means that around six million more vaccine doses can now be rolled out in the US coronavirus immunisation programme, adding to the almost three million doses of Pfizer/BioNTech’s already-approved shot which started to be administered a few days ago.
The emergency use authorisation (EUA) for mRNA-1273 came the day after the FDA’s advisory panel voted 20-0 with one abstention that the benefits of the vaccine outweighed the risks for people aged 18 and over.
Moderna said delivery of supplies of mRNA-1273 will begin immediately, and reiterated its intention to provide 20 million doses to the US government out of its total order of more than 200 million before the end of this month.
The biotech now expects to have between 100 and 125 million doses available in the first quarter of 2021, of which 85 to 100 million have been claimed by the US.
On Friday meanwhile, the European Commission said it had exercised an option for an additional 80 million doses of Moderna’s product, taking its total order to 160 million doses. The UK has ordered seven million doses, Japan 50 million and South Korea 20 million.
The new supplies come as a quarter of a million new cases are being recorded each day in the US, the highest national rate in the world, with daily deaths averaging around 2,500 in the last couple of weeks.
Some US states re already saying they are unable to get access to promised supplies of Pfizer and BioNTech’s BNT-162b, as federal officials suggested manufacturing issues were at risk of holding up supplies of the shot – although that has been disputed by Pfizer. The US government’s objective is to have 100 million people vaccinated by April.
“It has been less than a year since the world first learned of SARS-CoV-2 and the terrible disease it can cause,” said Francis Collins, director of the US National Institutes of Health (NIH) which carried out clinical trials of mRNA-1273 and also contributed a technology used to stabilise the jab.
“To have not one but two safe and highly effective COVID-19 vaccines ready for deployment to the American public is truly a remarkable scientific achievement, and a significant step toward ending the pandemic that has caused so much suffering,” he added.
Moderna’s vaccine should be easier to distribute than the Pfizer/BioNTech shot as it requires temperatures of around -20 C for shipping – similar to a normal freezer – rather than -70 C.
The company has also updated its handling guide for the distribution for mRNA-1273 to include local transport under controlled conditions in a liquid state at 2-8 C, noting that “this important update eases the logistical burden of transporting the vaccine to more remote locations and ensures that the barriers to being vaccinated are lowered.”
The post Moderna’s COVID-19 vaccine is second for US after FDA green light appeared first on .
A Belgian minister has inadvertently blown the lid off a sensitive and commercial secret – the price that the EU has agreed to pay for the leading Covid vaccines.
Belgium’s budget state ecretary, Eva De Bleeker, posted the price list on Twitter, with the amounts of each vaccine that her country intends to buy from the EU. The tweet was quickly deleted, but not soon enough to prevent interested parties taking screenshots, which have now made it public knowledge.
Johnson & Johnson: $8.50
America’s biopharmaceutical companies are committed to COVID-19 treatment and vaccine research and development (R&D). Reliable IP protections have helped drive innovation and enhance patient access to breakthrough therapies. Innovators are also relying on these strong protections to discover new medical advances that will keep patients healthy during this pandemic and after.
Researchers in the UK have developed a chatbot-enabled website that can train people to detect and counter misinformation on COVID-19 and other topics, using techniques from some of philosophy’s greatest critical thinkers.
Earlier this year, the World Health organisation (WHO) said the world was dealing with an “infodemic” that is accompanying the pandemic and it is hard for the general public to recognise the “grey area of” misinformation.
Do masks actually protect your from coronavirus? Is it similar to the flu in severity, and was it man-made and developed by governments to force mass vaccinations? The Fake News Immunity Chatbot won’t answer those questions directly, but aims to give people the skills to make up their own mind.
It takes the form of an interactive quiz, presented as a question and answer session between the user and other figures like Aristotle, Socrates and Gorgias, that encourages them to look into the facts beyond the headlines.
Using the exchanges, users can gauge whether they would fall for misinformation – what the researchers call semi-fake news – information that is misleading but not intentionally produced, unlike disinformation or fake news.
Semi-fake news can derive from misinterpretation of study findings, cherry picking of data points to suit someone’s bias, anecdotal stories, or hasty generalisations – which can all be hard to spot.
The chatbot has been designed by researchers at the Universities of Liverpool and Dundee to coach anyone with the skills needed to cut through the noise.
Users choose an identity and are then guided through a discourse with the three philosophers, as each teaches their rhetoric speciality: Aristotle explains the ten fallacies, Socrates encourages the need to question everything and Gorgias challenges mainstream opinions.
“Our chatbot is unique as it allows people to play and be trained by the greatest thinkers and become their own fact-checkers,” says Dr Elena Musi of Liverpool University’s department of communication and media, who is leading the project.
“You can play by yourself or encourage family, friends or colleagues to join in so you can quiz each other,” she adds. “Learning together and helping each other to understand how news is produced for different purposes provides the necessary skills needed to flag misleading content in our news feeds.”
The game has three levels – credulous, sceptic and agnostic – with users competing to pick up points shaped as gadflies.
Why gadflies? Plato described Socrates as a gadfly stinging people with questions to keep them on a virtuous path.
“We hope that with our chatbot, people will develop critical thinking that strengthens their digital literacy and helps them and their communities to become more resilient to information manipulation,” according to Musi.
“Acquiring critical digital literacy collectively, can help us build a healthier, stronger and smarter democracy.”
The chatbot was developed with the help of £200,000 in UK government funding.
The post Would you fall for COVID misinformation? Chatbot can help you find out appeared first on .
Tik Tok is unlikely to spring to mind as a source of reliable information about complex issues, but scientists are using it to fly the flag for COVID-19 vaccines and other health topics.
The social media platform, which allows users to share short and often frivolous video clips, has a growing number of experts using it to communicate important information to a broad audience, and particular teenagers and young adults.
One such scientist is Dr Anna Blakney (pictured above left), who is working on the COVID-19 vaccine project underway at Imperial College London in the UK and has attracted an impressive 205,000 followers.
She told the BBC that her approach on TikTok is “come for the entertainment, but stay for the science.” Her videos cover a host of topics from the science behind the immune system, side effects caused by the shots and vaccine hesitancy and the clinical and regulatory path to approval.
Another is Dr Austin Chiang, a gastroenterologist and the chief medical social media officer at Jefferson Health in Philadelphia, who said in an interview with the New York Times that covering vaccine-related topics on TikTok can be a minefield.
“When we talk about vaccines as health professionals, people who are vehemently anti-vaccine can take it out of context for their agenda. That makes me hold back sometimes,” said Chiang.
“The approach that I try to take is to leave room for the grey. If you say vaccines don’t cause any harm and are the best things in the world, it can alienate people who are vaccine hesitant. If we instead acknowledge that there are risks just like anything else in medicine and life, it’s a more effective message.”
TikTok itself meanwhile says it has taken steps to make sure its users have access to reliable information about the pandemic, which will be stepped up as immunisation programmes start in the UK, US and elsewhere.
Kevin Morgan, head of product and process, Europe, at the social media firm, notes in a blog post that in January it introduced an in-app notice so that when users searched for hashtags related to the pandemic, they would be provided with easy links to the World Health Organisation’s website and the British Red Cross.
The following month it rolled out an information hub in-app to provide the TikTok community with access to accurate information, which has been viewed 2 billion times since June and will be updated on 17 December with new information on vaccines
“Additionally, we will soon introduce a new vaccine tag to detect and tag all videos with words and hashtags related to the COVID-19 vaccine,” says Morgan.
“We will attach a banner to these videos with the message ‘Learn more about COVID-19 vaccines’,” which will redirect users to “verifiable, authoritative sources of information.”
The post Scientists and medics turn to TikTok to reassure public on vaccine safety appeared first on .
once an intriguing proposition struggling to reach its potential, became an
absolute necessity in 2020. In the early days of COVID-19, as medical centers
labored to deal with an influx of patients while also trying to mitigate
coronavirus spread, telemedicine was urgently needed as an option for providing
healthcare to others at a safe distance. In the U.S., the government and
providers quickly started to take measures to facilitate its use during the
crisis of the pandemic.
In some ways it’s
hard to understand why telemedicine wasn’t already in widespread use,
though, considering that people are increasingly preferring to do everything
from banking to grocery shopping online. Why not healthcare as well?
A new webinar, Emerging Trends in Telemedicine, offers some insight. Moderated by Elsevier’s Ann Gabriel, the webinar includes an international panel featuring Dr. Amol Navathe (Philadelphia VA Medical Center, University of Pennsylvania), Dr. Heather Ross (Toronto General Hospital, University of Toronto), and Dr. Robin Ohannessian (Public Health specialist, Director of Télémédecine 360).
In this fascinating
discussion, the panelists talk about the many challenges of telemedicine, which
include hurdles like regulatory standards, privacy and security concerns, the
need for political buy-in, insurance coverage and pricing for telemedicine
visits, and technology requirements. These issues and more have contributed to
the relatively sluggish rate of adoption of telemedicine prior to the pandemic.
The good news is
that is changing – and while those hurdles are still high, they are hardly
insurmountable. The panelists reveal some of the ways that they have seen
governments, doctors, patients and the healthcare system as a whole start to
embrace telemedicine and they offer some thoughts as to how it can be most
The webinar also
includes the presentation of some fascinating data and polling results that
offer further insight into the latest trends around telemedicine and its
To learn more, watch the webinar here.
British American Tobacco has moved a step closer to producing a vaccine for coronavirus using tobacco plants, as it won approval in the US to begin testing on humans.
The company behind cigarette brands including Lucky Strike, Rothmans and Benson & Hedges said the US Food & Drug Administration had given it clearance to begin a clinical study with adult volunteers.
The global scheme to deliver Covid-19 vaccines to poorer countries faces a “very high” risk of failure, potentially leaving billions of people with no access to vaccines until as late as 2024, internal documents say.
The Covax scheme has been beset by a number of issues, including a shortage of doses of approved vaccines, and a decision by India’s Serum Institute, which was initially earmarked to supply Covax, saying it would prioritise supplying India first.
AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University.
In a joint statement, the biotech and the university said that the antibody, dubbed ABBV-47D11, will be developed for prevention and treatment of COVID-19 and related coronaviruses.
AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.
The antibody has been developed by Harbour using transgenic mice, which enabled the quick discovery and development of several candidates.
From these ABBV-47D11 was selected because of its cross-reactive neutralising nature.
The antibody targets a conserved region of the SARS-CoV-2 spike protein and has been developed through a collaboration between Harbour (HBM) and Utrecht University (UU).
The license agreement will help advance the development of ABBV-47D11, which in pre-clinical research demonstrated potential against SARS-CoV-2, as well as the related SARS-CoV-1 virus that caused an outbreak in Asia in 2003.
AbbVie will conduct clinical development of ABBV-47D11, and if successful, will manufacture and market the product worldwide.
AbbVie will pay HBM and UU an undisclosed one-time license fee and will also make payments upon achievement of certain development, regulatory and sales-based milestones.
The pharma will also pay tiered royalties on commercial net sales of the antibody.
Erasmus University Medical Center, based in Rotterdam, Netherlands, was involved in the fundamental science but is not involved in the license agreement.
The phase 1 trial will be a randomised, double-blind, placebo-controlled, study to evaluate the safety, pharmacokinetics, and pharmacodynamics of single ascending doses of ABBV-47D11 in adults hospitalized with COVID-19.
The antibody will be tested in three different doses on 24 patients across global study sites to evaluate study-drug related adverse events as primary endpoints, and several other secondary outcomes.
Regeneron and Eli Lilly have been leading the charge to develop antibody-based therapies against the coronavirus.
Regeneron’s cocktail, REGN-COV2 and Eli Lilly’s bamlanivimab have emergency approvals from the FDA and AstraZeneca has begun clinical development of its rival antibody cocktail last month.
Harbour BioMed is a clinical-stage biotech specialising in antibody therapeutics with operations in Cambridge, Massachusetts; Rotterdam, The Netherlands; and Suzhou and Shanghai, China.
Feature image courtesy of Rocky Mountain Laboratories/NIH
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Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing its safety and rating its efficacy at 94.5%.
The document has been published just after the US started the rollout of Pfizer and BioNTech’s vaccine after it got an emergency green light last week, and ahead of an expert panel due to consider Moderna’s shot on Thursday.
If the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) agrees with the agency’s assessment it could be available before the end of the week, accelerating the pandemic immunisation programme.
Like Pfizer/BioNTech’s BNT-162b, Moderna’s mRNA-1273 is based on messenger RNA coding for the SARS-CoV-2 spike protein, and will be administered in a two-dose regimen given a few weeks apart.
The FDA says no specific safety concerns with mRNA-1273 have been seen in the 30,400-patient COVE trial that underpins the EUA application, with minor effects like fever, headache and fatigue common but manageable, a serious side effects rare.
The overall 94.5% efficacy rating two weeks after the second dose is in line with interim data from the trial, although the FDA notes that it seems to be less effective in older people.
For the 18 to 64 age group efficacy comes in at 96%, but drops to 86% in the over-65s – both values are way above the threshold that should be needed to support emergency use during the pandemic.
The shot also worked equally well in white, black and Hispanic subjects, men and women, and those with conditions like obesity and diabetes that increase the risk of severe COVID-19.
Importantly, there was also some preliminary data pointing to a reduction in asymptomatic SARS-CoV-2 infections – something that hasn’t yet been demonstrated with other vaccines – as well as prevention of severe disease.
All told, 38 trial participants in the placebo arm of the trial tested positive for asymptomatic COVID-19 at the time of their second dose, well above the 14 positives in the mRNA-1273 arm.
If the VRBPAC votes in favour of mRNA-1273 shipments are expected to begin within 24 hours, and Moderna has said it expects to be able to provide up to 6 million doses in the initial rollout, adding to around 3 million doses of the Pfizer/BioNTech jab.
The first doses of BNT-162b are being used to treat healthcare workers and elderly people in care homes, and it will be many months before vaccinations are available for all America’s 330 million population. Both vaccines will be provided free of charge to recipients.
The federal government has already signed supply agreements with Moderna and Pfizer/BioNTech for 300 million doses in 2021, enough to dose 150 million people. mRNA-1273 requires less intensive refrigeration that BNT-162b, so could be more suitable for distribution to more remote areas of the US.
There is also hope that vaccines from Johnson & Johnson and AstraZeneca could also be available in the first quarter of 2021.
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Vaccinating the population against Covid-19 will cost up to £12bn, Whitehall’s spending watchdog has disclosed, amid details of tensions between health bodies over the rollout.
The National Audit Office said the government would spend up to £11.7bn on purchasing and manufacturing Covid-19 jabs for the UK before deploying them in England.
The 2020 election was defined by a wide range of unique, and in some cases, unprecedented factors. From a global pandemic to never before seen rates of mail-in ballot casting and record voter turnout across the country, this election cycle was unlike any other we have seen in recent history. Thus, it may not be surprising that in some cases where we saw candidates adhering too closely to a traditional campaign playbook, election outcomes turned out in ways we did not anticipate.
Hospitals in the US have started vaccinating their front-line staff against COVID-19, as deaths in the country crossed the 300,000 threshold with more than 200,000 new cases reported yesterday.
Shipments of Pfizer/BioNTech’s mRNA vaccine BNT-162b are being shipped to hundreds of hospitals and other distribution facilities across the US, with the first three million doses earmarked for healthcare workers and elderly.
Just three days after the FDA granted Emergency Use Authorisation for the shot, the first dose administered outside a clinical trial was given yesterday to intensive care nurse Sandra Lindsay at the Long Island Jewish Medical Center in Queens, New York.
It’s likely to be months before all eligible healthcare workers for the first wave receive vaccinations. Hopeful eyes are already turning to the Moderna’s mRNA-1273 vaccine, which is scheduled to be reviewed by FDA advisors on Thursday, to help boost available supplies.
The first nursing home residents aren’t expected to start receiving their doses until next week, according to Army General Gustave Perna, chief operating officer for Operation Warp Speed, the US vaccination task force.
The immunisation programme comes as hospitals around the country say they are already struggling to cope with the influx of COVID-19. The US has the highest death toll from the disease worldwide, ahead of Brazil, India and Mexico, and there are fears of a further spike as the holiday season gathers pace.
The US government is predicting that 20 million Americans will have received at least one of the two doses of the vaccines by the end of the year, with another 30 million set to be immunised during January and another 50 million by the end of March.
President Trump took a break from his relentless tweeting about alleged election fraud to briefly acknowledge the milestone on the path to recovery from the pandemic.
Canada also gave the first doses of BNT-162b to healthcare workers yesterday, a week after the UK started the ball rolling on its own vaccination programme – the first to get started in the world.
Because BNT-162b is made from RNA, it has strict temperature requirements and has to be stored at -70 C in dry ice to prevent it from breaking down, although it can be kept at regular refrigeration temperatures temporarily – around three days – after being defrosted for administration.
That will pose a logistical challenge for all countries, requiring a massive and carefully controlled shipping operation as doses come off the production line at Pfizer’s facility in Michigan.
Around 5 million doses of Moderna’s vaccine could be ready to ship straightaway if the FDA gives a green light, possibly as soon as Friday, with distributor McKesson handling that roll-out. Moderna’s shot is a little easier to handle as it only needs to be kept at -20 C.
Meanwhile, Operation Warp Speed’s chief executive Dr Moncef Slauoi also suggested yesterday that Johnson & Johnson could get approval for its shot in late January or early in February, while AstraZeneca may be in a position to seek FDA approval as early as February.
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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 response in older adults.
While antibody levels were comparable to those seen in recovering COVID-19 patients in adults aged 18-49, the response was lower in older adults.
This was likely due to an insufficient concentration of the antigen, according to a team of analysts from Jefferies investment bank, who said the companies have decided to investigate an improved formulation.
This demonstrated rapid viral clearance in a challenge study in non-human primates.
A phase 2b study is expected in February next year with support from the US government agency, the Biomedical Advanced Research and Development Agency (BARDA).
This could lead to a phase 3 study next summer and an authorised product at the end of next year delaying deliveries of potentially more than a billion shots, enough to protect half a billion people.
The US government has an agreement to buy 100 million doses, with an option for another 500 million doses and has funded development to the tune of $2.1 billion.
The European Commission has an agreement for 300 million doses, the UK has ordered 60 million doses and the Canadian government has ordered 72 million doses.
AZ to combine vaccine with Russian rival
In a separate development it has emerged that AstraZeneca is to test its whether its COVID-19 vaccine can be combined with a component used in Russia’s Sputnik V shot, according to a statement the government-backed Russian Direct Investment Fund (RDIF).
Clinical trials so far have shown that Sputnik V, which uses two different types of viral vector to produce an immune response, provides protection in around 90% of cases.
The RDIF, which has helped bankroll the vaccine, said AZ had accepted a proposal to begin trials of its AZD-1222 in combination with Sputnik V’s human adenoviral vector type Ad26 by the end of the year.
AZ has already announced findings suggesting that using an initial lower dose of the vaccine produces a protection level of around 90%, while using two maximum strength doses produced protection levels of just over 60%.
The idea behind Sputnik V, developed by a team of scientists from Moscow’s Gamaleya Center, is to use two shots using different viral vectors to reduce the risk of the body developing resistance and not producing a boosted immune response to the second booster shot.
AZ’s vaccine, developed in partnership with Oxford University, looked like one of the most promising vaccine candidates until it was hit with a safety scare that caused trials to be put on hold for a few weeks in September.
While regulators later decided that trials could continue, the announcement that researchers had accidentally stumbled on the low-dose high-dose combination did not go down well and caused the company’s share price to tumble.
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A coronavirus vaccine being developed by GlaxoSmithKline and its French partner, Sanofi, will be delayed until the end of next year after trials revealed it failed to produce a strong immune response in older people.
The drug companies hoped to have regulatory approval for the candidate vaccine in the first half of 2021, but interim results from a phase 1/2 trial showed an “insufficient” response in the over-50s, the age group most vulnerable to severe Covid-19.
Now that the UK has authorised the first Covid vaccine, who will get it first?
The UK has become the first country to approve one of the coronavirus vaccines that the entire world has been desperately waiting for. And on Tuesday it delivered the first dose, to 90-year-old Margaret Keenan in Coventry. We should be very pleased about this. But, as with every other stage of the pandemic, the final stretch brings a new set of unprecedented challenges. The world is watching as the UK becomes the first test case of our collective ability to manufacture, ship, and deliver an entirely new class of vaccines, on a scale and speed that no previous vaccination drive in history has ever approached.
The thing everyone knows about the Pfizer-BioNTech vaccine is that it needs to be extremely cold. The mRNA that makes up the vaccine payload is the same stuff your cells use to send short-lived genetic instructions. It’s a messenger that isn’t supposed to stick around, as temporally fragile as a Snap on Snapchat. The vaccine is happiest at -70C, and after thawing can be kept at between 4C and -8C – the temperature of a regular fridge – for just five days before it degrades. Most logistics providers aren’t set up to ship at -70C, and while university labs and large hospitals generally have some -70C freezers, GP surgeries and smaller centres do not. The temperature for shipping and storage has been identified as one of the biggest challenges in getting this vaccine out.
The Pfizer/BioNTech Covid jab is an mRNA vaccine. Essentially, mRNA is a molecule used by living cells to turn the gene sequences in DNA into the proteins that are the building blocks of all their fundamental structures. A segment of DNA gets copied (“transcribed”) into a piece of mRNA, which in turn gets “read” by the cell’s tools for synthesising proteins.
Stephen Buranyi is a writer specialising in science and the environment
The European Medicines Agency (EMA) says it suffered a cyberattack, with documents relating to a Pfizer and BioNTech’s COVID-19 vaccine accessed.
In a terse statement, the EU regulator confirmed its security had been breached and said it had launched an investigation with law enforcement, but would not be providing any additional information while that probe was underway.
Shortly after however BioNTech confirmed that documents submitted as part of its marketing application for coronavirus vaccine BNT-162b had been accessed by the hackers.
Responding to fears that the review could be delayed, the company said it had been assured by the EMA that the timeline should not be affected. The agency has indicated it should complete its review by 29 December.
BNT-162b is already approved in the UK and Canada, and the first UK patients started to receive the shot on Tuesday this week. The EMA is also reviewing another vaccine from Moderna, but at the moment it’s not clear if data from that programme has also been compromised.
“It is important to note that no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware that any study participants have been identified through the data being accessed,” said BioNTech in a statement on its website.
It added that it had publicised the breach “given the critical public health considerations and the importance of transparency”.
The cyberattack came just days after international enforcement agency Interpol warned that organised criminals may try to target COVID-19 vaccine supply chains, for example by falsification, theft and illegal advertising of unlicensed shots.
Europol meanwhile warned earlier this year that criminal networks are exploiting the COVID-19 pandemic with a surge in cybercrime, targeted thefts and counterfeiting, including attempts to target organisations through business email compromise (BEC), which can be used to harvest sensitive data, siphon off funds or damage its reputation.
There’s no indication yet who was behind the EMA hack, but a volunteer group set up to tackle cybercrime related to COVID-19 – CTI League – has suggested that one motivation could be to uncover details about the supply and distribution of vaccines.
The group’s found Marc Rogers told Reuters that information “potentially significantly increases the attack surface for the vaccine”.
IBM recently said an email phishing campaign had targeted organisations linked to the Cold Chain Equipment Optimisation Platform (CCEOP) of Gavi, the international vaccine alliance, suggesting that the sophistication of the assault pointed to a nation state being the culprit.
“Without a clear path to a cash-out, cyber-criminals are unlikely to devote the time and resources required to execute such a calculated operation,” according to the tech giant’s Security X-Force.
There has also been reports that hackers linked to North Korea, South Korea, Iran, Vietnam, China and Russia have tried to steal information about vaccines, targeting pharma companies and other organisations involved in COVID-19 medicine R&D, according to the news agency.
In October, Indian pharma company Dr Reddy’s Laboratories, which is helping to conduct late-stage testing of Russia’s Sputnik V COVID-19 vaccine, said it had been hit by a cyberattack that disrupted its production facilities.
Sam Curry, chief security officer at Cybereason, is convinced that a nation state is behind the EMA attack, saying: “Cyberattacks on the global COVID-19 vaccine distribution network from nation-states China, Russia and North Korea are diabolical in nature and acts of war.”
While acknowledging the average person “might be asking themselves why nation-state actors…are deliberately sowing doubt and confusion around the world at the worst possible time,” Curry says there is tremendous value in interfering with the distribution of COVID-19 vaccines.
“A COVID-19 vaccine is a strategically valuable asset to nation-states; whoever gets a vaccine distributed first has an economic advantage. It is the ultimate IP with immediate value. It is like having an oil rush, a data advantage or territorial gain in older real political terms.”
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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 to avoid the vaccine.
According to press reports, Slaoui expects an influential FDA advisory committee to say today that people with severe allergies “should not take the vaccine until we know exactly what happened.”
According to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), people with a “significant history of allergic reactions” should avoid the shot.
This followed two NHS staff members, who both carried adrenaline auto-injectors and had a history of allergic reaction, developing an anaphylactoid reaction after receiving the vaccine on Tuesday.
These individuals developed symptoms of anaphylactoid reaction – a milder reaction than a severe anaphylactic shock – shortly after receiving the vaccine. Both recovered after appropriate treatment.
Professor Stephen Powis, national medical director for the NHS, said in a statement: “As is common with new vaccines the MHRA have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination after two people with a history of significant allergic reactions responded adversely yesterday. Both are recovering well.”
It’s an issue that’s also likely to come up at today’s meeting of US vaccine experts, who are advising the FDA on whether to go ahead with an Emergency Use Authorization for the shot.
FDA reviewers have already concluded that the vaccine is safe and effective in a briefing document ahead of the Vaccines and Related Biological Products Advisory Committee’s meeting.
The committee will meet in public to discuss the shot and although the FDA is not bound to follow its advice, the regulator usually follows its experts’ advice when making decisions on drugs.
The regulator has run its own analysis of the vaccine and concluded there was a “slight numerical imbalance”, with more adverse events representing allergic reactions in those taking the vaccine compared with the placebo group.
There were 137 people reporting hypersensitivity-related adverse events in the vaccine group and 111 in the placebo group, according to the analysis in the briefing document.
This represented a tiny fraction of the 38,000 people tested in the phase 3 trial at the time of data read-out although the trials so far have excluded people with histories of allergic reactions.
Feature image copyright BioNTech SE 2020, all rights reserved
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German biotech firm BioNTech said on Wednesday that regulation documents related to the Covid-19 vaccine it has developed with Pfizer were “unlawfully accessed” after a cyber-attack on Europe’s medicines regulator.
Earlier, the European Medicines Agency (EMA) – which is responsible for assessing and approving vaccines for the European Union – said it had been targeted in a cyber-attack. It gave no further details.
For a man presenting landmark results from trials of a vaccine that it is hoped will save the world from a devastating pandemic, Sir Menelas Pangalos did not look cheerful on Wednesday.
Pangalos, executive vice-president of biopharmaceuticals R&D at AstraZeneca, and his colleagues are undoubtedly exhausted, having been working round the clock on the coronavirus vaccine with Oxford University since April. But they are now dealing with a sizeable new headache – the doubts of the US regulator.
Regulators have issued a warning that people who have a history of “significant” allergic reactions should not currently receive the Pfizer/BioNTech Covid-19 vaccine after two people who had the jab on Tuesday had allergic reactions.
Two NHS staff members who received the vaccine on the first day of the mass vaccination programme experienced an allergic reaction, the NHS in England has confirmed.
Nine out of 10 people in 70 low-income countries are unlikely to be vaccinated against Covid-19 next year because the majority of the most promising vaccines coming on-stream have been bought up by the west, campaigners have said.
As the first people get vaccinated in the UK, the People’s Vaccine Alliance is warning that the deals done by rich countries’ governments will leave the poor at the mercy of the rampaging virus. Rich countries with 14% of the world’s population have secured 53% of the most promising vaccines.
US Food and Drug Administration (FDA) staff said on Tuesday that data on Pfizer’s coronavirus vaccine was in line with its guidance on emergency use authorization, raising hopes it could soon be available to Americans aged 16 and above.
The comments were made in documents released ahead of Thursday’s meeting of outside experts to discuss whether the vaccine developed by Pfizer with German pharmaceutical partner BioNTech should be authorized for emergency use in America.
A new Health Union survey reveals that people with chronic conditions feel that telehealth, despite its convenience and increased use throughout the COVID-19 pandemic, is generally less preferable than in-person visits, but can still serve as an occasionally suitable alternative. The survey is the fifth in Health Union’s ongoing COVID-19 Consumer Attitudes and Health Behaviors Survey series that captures “snapshots in time” that track the perspectives and health behaviors of people with chronic conditions throughout the pandemic.
Telehealth use continues to increase during the pandemic for people living with chronic health conditions. Nearly three-fourths of respondents of this wave 5 survey said they have had at least one telehealth appointment, up from 63% from the wave 4 survey, which fielded in July.
Fortunately, two-thirds of respondents who have had telehealth appointments considered their experiences to be positive, with convenience being a primary reason. And 44% of all respondents said they were “extremely likely” to consider using telehealth after the pandemic is under control. This number was even higher for people living with autoimmune conditions, such as ankylosing spondylitis (61%), Crohn’s disease (61%) and plaque psoriasis (56%).
However, the survey findings reveal that increased use doesn’t necessarily translate into a clear preference for telehealth.
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Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view.
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 week became the first country in the world to officially authorise the vaccine, which has so far shown an effectiveness of around 95% and minimal side effects in a late-stage clinical trial.
But the logistics of delivering the vaccine are hugely challenging, with up to 4 million sent out this month alone.
The most at-risk groups of people will be first to get the vaccine, with people in care homes, those aged over 80 and healthcare workers targeted first.
On top of this is the requirement for the cutting-edge RNA-based vaccines to be stored at ultra-low temperatures.
According to Luxembourg-based cold chain specialist B Medical Systems, demand for ultra-cool freezers has gone “off the chart” in recent weeks.
Pfizer’s vaccine needs to be stored at around -70C to retain its integrity, while its rival from Moderna that is under review by regulators needs to be stored at -20C.
The company has developed a product that can operate as both a vaccine freezer and a vaccine refrigerator, which could be used to store the Pfizer/BioNTech and Moderna vaccines, as well as the potential shot from AstraZeneca that requires standard refrigerator temperatures for storage.
However the waiting list for the vaccine fridges is expected to grow as more and more companies authorise various coronavirus vaccines.
CEO Luc Provost said: “Normally we would be supplying 2,000-3,000 units typically for a country. We expect this to increase 5-7 fold to some 15,000 units at least. In places like India we are seeing orders reach six figures.”
The biggest challenge is maintaining an unbroken “cold chain”, something that is already common in medicine logistics, but more challenging on this occasion because of the specialist requirements of the vaccine and the sheer scale of the operation.
According to Provost the biggest challenge will be distribution within the UK and other countries and in particular “the last mile” to the patient.
“Vaccine wastage happens in two areas – in-country transport and vaccine administration at health facilities.
“Most portable vaccine carriers and cold containers cannot keep cold beyond 12 hours, especially if it is hot outside.
“Transportation for the last mile to where the immunisation is happening – for example care home residents which will be amongst the first in the UK to get vaccinated – is time consuming and monitoring this journey presents a big problem.”
Feature image copyright BioNTech SE 2020, all rights reserved
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Batches of the Covid vaccine have begun to arrive in hospitals around the UK, ready for the first jabs on Tuesday in what NHS England’s medical director warned would be the largest and most complex vaccination campaign in the country’s history.
The UK’s record-breaking approval of the vaccine and the rapid start of immunisation against Covid-19 did not mean the end of the pandemic was in sight, said Prof Stephen Powis. It would be a marathon and not a sprint, he said.
Public health messaging that people can have faith in the safety of coronavirus vaccines is “vitally important”, the leader of the body that has approved the Pfizer jab has said.
Dr June Raine, the chief executive of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), said of the Pfizer treatment that there “should be no doubt whatever that this is a very safe and highly effective vaccine”.
In the early afternoon of 3 January this year, a small metal box was delivered to the Shanghai Public Health Clinical Centre addressed to virus expert Prof Zhang Yongzhen. Inside, packed in dry ice, were swabs from a patient who was suffering from a novel, occasionally fatal respiratory illness that was sweeping the city of Wuhan. Exactly what was causing terrifying rises in case numbers, medical authorities wanted to know? And how was the disease being spread?
What Zhang did was critical … Without the information he provided no one could have started working on vaccines
Never before has the world awaited a new medicine with such bated breath. A vaccine for Covid-19 has the potential to unlock society and save millions of people from death and serious disease, and the hero of the hour is an industry that is often regarded with disdain.
“Traditionally and historically, public trust in pharma has been comparable to the trust they put in their broadband provider,” said Alex Davies, a healthcare PR expert at Hanover Communications, which counts many drug companies as clients.
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view.
Today, we are pleased to welcome a guest post Michel Pairet, a member of the Board of Managing Directors in charge of Innovation at Boehringer Ingelheim and Clive R. Wood, Global Head of Discovery Research.
In the midst of the jubilation about the UK’s emergency approval of Pfizer/BioNTech’s COVID-19 shot in the UK came the depressingly inevitable round of anti-vaccine social media activity and lobbying.
The green light for BNT162b was swiftly followed by posts on Twitter likening the vaccine to thalidomide – the drug that notoriously resulted in thousands of children being born with birth defects in the 1960s.
That ignores the fact that the thalidomide tragedy itself was responsible for the introduction of evidence-based medicine and reforms to the regulatory system that keep patients safe today.
While thalidomide is trending in the UK, it’s worth noting that many tweets are being posted by people slamming the #antivaxxers – a hashtag that is currently also riding high.
The Medicines and healthcare products regulatory Agency (MHRA) has been warning for some against anti-vaccine rhetoric that it fears could derail the coronavirus vaccination programme – which would be larger than any adult campaign carried out to date.
Pre-empting the backlash, MHRA’s chief executive Dr June Raine said at a Downing Street press briefing that despite the speed of its review, completed just three weeks after the final data were made available, no corners had been cut.
The vaccine had been approved after “an extremely thorough and scientifically rigorous review of all the evidence of safety, of effectiveness and of quality,” she asserted, adding: “The safety of the public will always come first.”
As the vaccine starts to be distributed, the National Institute for Biological Standards and Control (NIBSC) will be carrying out independent lab tests to confirm that every single shot that goes out meets the required standards for safety and quality, according to Raine.
Anti-vaxxers have been responsible for promulgating a series of fantastical rumours and conspiracy theories about coronavirus vaccines, including a persistent claim that vaccination will result in people being implanted with a microchip that will be used to track them.
Other false claims are that RNA-based vaccines like BNT162b can alter a recipient’s DNA and that the shots will contain tissue from aborted foetuses.
While some of these are frankly comical, the fear is that the spread of misinformation into mainstream media sources could result in fewer people taking up the opportunity to be vaccinated, undermining the programme.
Research published by the Vaccine Confidence Project – a unit of the London School of Hygiene & Tropical Medicine – found that misinformation around a COVID-19 vaccine induced a fall in the willingness to receive it among those who would otherwise “definitely” vaccinate.
VCP’s study found that only 54% of UK people would definitely have a COVID-19 vaccine – higher than the 41% seen in the US – with most of those who were reluctant citing safety concerns or a sense the threat posed by the pandemic had been overblown.
That’s already fewer than is required for herd immunity – a level of protection that would impact on virus transmission – but most worrying was that exposure to misinformation reduced the proportion of those definite responses by more than 6%.
“I hope that enough people take these vaccines, but I think it is going to be much more of a challenge than is recognised,” VCP director Heidi Larson told the Financial Times this week.
Speaking to the BBC today, Pfizer’s country manager for the UK, Ben Osborn said that “after the provision of clean water, vaccines are…the single most effective public health intervention we can make”. He also stressed that the study behind the approval was assessed by an independent panel with no links to Pfizer and BioNTech.
Health secretary Matt Hancock has also responded to questions about the anti-vax movement today, telling LBC radio that “the good news is that it’s not growing”.
“We monitor this very carefully and actually the number of people who want to have the vaccine is increasing,” he said
“The regulators are fiercely independent – they would not approve this if it wasn’t safe.”
800,000 doses of BNT162b have passed batch testing and should be ready within the next few days, and will be prioritised for elderly people in care homes and care home staff, followed by over-80s and health and care service workers.
The UK has ordered 40 million doses – enough for 20 million people – with several million doses expected to be available by year-end. Scottish leader Nicola Sturgeon said the first vaccines would be available in Scotland from Tuesday next week.
Twitter has also seen a debate about how the UK was able to become the first country in the world to approve the vaccine.
Hancock said the country was able to move quickly because of Brexit, but Raine emphasised in the press briefing that the approval was “made under provisions under European law which exist until January 1”.
The European Medicines Agency will meet on 29 December to decide if the safety and efficacy of Pfizer and BioNTech’s vaccine supports its approval.
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Covid vaccine with an efficacy of almost 95% has been authorised by the UK medicines regulator
The Pfizer/BioNTech Covid vaccine, which has an efficacy of almost 95%, has been authorised by the UK medicines regulator, making the UK the first western country to license a vaccine against the disease. The UK has 40m doses of this vaccine on order.
Moderna has said it will file for US, European and UK emergency approval of its coronavirus vaccine straight away, after reporting updated phase 3 results for the shot.
The primary analysis from the 30,000-subject COVE trial of mRNA-1273 – based on 196 confirmed cases of COVID-19 – has come in at 94% efficacy, with 185 cases in the placebo arm and just 11 among those given the vaccine after two months of follow-up.
The efficacy rate is almost identical to an earlier readout after 95 confirmed cases of COVID-19 in COVE, which is being run by the US National Institute of Allergy and Infectious Diseases (NIAID), and the safety profile also looks clean, according to Moderna.
It also appears to prevent volunteers from getting very sick from the virus, as all 30 cases of severe COVID-19, and single coronavirus-related death, were in the placebo arm.
The FDA and EMA will now look at the results and see if the mRNA-based vaccine can be given a green light for widespread use, and according to Moderna the data will be discussed at a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on 17 December.
Pfizer and BioNTech’s mRNA-based shot BNT162b was the first coronavirus vaccine to be submitted for emergency approval in the US on 20 November, but at the time of writing hadn’t yet been given a green light.
AstraZeneca and the University of Oxford’s adenoviral shot AZD1222 meanwhile has also been submitted for approval in Europe under the rolling review procedure, as well as in the UK. The company expects to file for approval in the US after the readout of a US trial in 40,000 patients that hasn’t yet generated results.
While AZD1222’s efficacy hasn’t matched the mRNA vaccines in trials so far, it will be cheaper and easier to distribute as it can be kept at standard refrigeration temperatures.
As it stands, the Pfizer/BioNTech shot has to be kept at -70 degrees Celsius – although the partners are testing stability at warmer temperatures – and Moderna has data suggesting its vaccine is stable for a month in standard refrigeration once taken out of a freezer.
AZD122 is expected to cost around $4 per dose, compared to approximately $20 for BNT162b and $32-plus for mRNA-1273.
Russia’s adenoviral shot Sputnik V meanwhile has a claimed efficacy of 92%, will cost less than $10 a dose, and can also be stored at standard fridge temperatures.
Moderna said that it will also seek prequalification and emergency use listing from the World Health Organization (WHO), which provide a route to market for vaccines, drugs and other healthcare products that meet pressing public health needs, particularly in low- and middle-income countries.
As with the other vaccine data readouts, there are still a lot of unanswered questions, including whether the shots can cut viral transmission rates – including asymptomatic transmission – how long protection may last, the impact on hospitalisation rates, and long-term safety.
“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalisations and death,” commented Moderna’s chief executive Stéphane Bancel.
The US biotech has reiterated its expectation of having 20 million doses of mRNA-1273 available by the end of the year, which is earmarked to supply the US, which has ordered 100 million doses. 50 million doses are also due to head to Japan, and 20 million to Canada, while the UK has just raised its order to 7 million.
Shares of Moderna were up more than 16% on the Nasdaq as the markets opened in the US.
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In a few days, researchers plan to solve a medical mystery that threatens to erupt into a major transatlantic battle. Scientists at Oxford University say they intend to publish full, peer-reviewed data, in the journal Lancet, about trials they have completed on their Covid-19 vaccine.
The information, they say, should end mounting controversy about the vaccine’s effectiveness and explain apparent inconsistencies in trial results. Opponents, most of them American, say this is unlikely, and insist new phase 3 trials now need to be restarted from scratch to restore confidence in the vaccine.
Concerns around the efficacy of the Oxford University/AstraZeneca coronavirus jab in older people could lead to different age groups being given different vaccines, experts have said.
The partners announced last week that the vaccine had a 70% efficacy overall. For most trial participants – given two full doses, spaced a month apart – the efficacy was 62%, but for 3,000 participants mistakenly given half a dose for their first jab, the efficacy was 90%. No participants, regardless of dosing, developed severe Covid or were hospitalised with the disease.
The world took note when the German startup BioNTech announced its breakthrough in the development of a new type of vaccine to combat Covid-19. After testing tens of thousands of people, BioNTech’s vaccine has been shown to be 95% effective in providing protection for those who would otherwise have been infected. The company was the first to apply for emergency use authorisation for a coronavirus vaccine in the US and it has announced it will soon take similar steps in Europe.
Antiviral vaccines are usually made with devitalised viral materials fabricated outside the body but BioNTech has pursued a new method of injecting genetically modified RNA into the patient. This prompts the patient’s cells to produce a characteristic protein of the relevant Sars-CoV-2 virus themselves, enabling the body’s immune system to build up an effective response before it encounters the real virus.
Colchicine, a cheap and readily available anti-inflammatory drug used to treat diseases such as gout, is to be investigated as a potential therapy for COVID-19 in the UK’s ground-breaking RECOVERY trial.
In a statement academics from Oxford University, which is running the trial, said that colchicine will be added to the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial from today.
Colchicine is derived from the autumn crocus and could be an important inclusion in the growing list of drugs that are being used against the disease if results are supportive.
RECOVERY is the world’s largest clinical trial of treatments for COVID-19 and is taking place in 176 hospital sites with over 18,000 patients recruited so far.
At least 2,500 patients are expected to be recruited to RECOVERY and will be randomly allocated to receive colchicine plus usual standard of care.
Results will be compared with at least 2,500 patients who receive the usual standard of care on its own.
Dosage used will be 1000 micrograms for the first treatment, then 500 micrograms every 12 hours for a total of 10 days or until discharge if sooner.
The main outcome the RECOVERY trial will assess is mortality after 28 days. Other outcomes include the impact on hospital stay and the need for ventilation.
Depending on recruitment rates, it is likely to be several months before there is enough evidence to conclude whether colchicine has a significant benefit in COVID-19 patients.
Other treatments being tested on RECOVERY include Roche’s Actemra (tocilizumab), convalescent plasma from donors who have recovered from COVID-19 containing antibodies against the virus, Regeneron’s antibody cocktail REGEN-COV2 and aspirin.
The trial has already shown that the dexamethasone, a cheap steroid, can cut mortality in patients with severe respiratory complications from COVID-19.
It has also shown that hydroxychloroquine, the anti-malarial touted by president Donald Trump as a potential therapy, produced no effect in COVID-19.
RECOVERY has been made possible by the UK’s National Health Service and its ability to coordinate a large clinical trial across the entire country.
Professor Peter Horby, co-chief investigator of the RECOVERY trial, said: “Colchicine is an attractive drug to evaluate in the RECOVERY trial as it is very well understood, inexpensive and widely available. If it works it would be another COVID-19 treatment that could be used immediately worldwide, even in the poorest countries.”
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Michael Safi, the Guardian’s international correspondent, explains why ‘vaccine nationalisation’ could scupper global efforts to kill the virus and examines what is being done to tackle the issue