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Pfizer applies for EU emergency authorisation for its coronavirus vaccine


With coronavirus cases around the world now at over 63 million, scientists have been working around the clock to develop a vaccine.

Jabs from Pfizer, Moderna and AstraZeneca are undergoing Phase 3 clinical trials, and now it seems that Pfizer’s offering could be one step closer to launching.

Pfizer and BioNTech have applied to the European drugs regulator for conditional authorization of their COVID-19 vaccine, following similar steps in the United States and Britain, the companies said on Tuesday.

The application to the European Medicines Agency (EMA) comes after the companies applied for U.S. approval on Nov. 20, taking them a step closer to launching their vaccine.

In their pursuit of a European launch, potentially this year, the partners are neck-and-neck with rival Moderna, which said on Monday it would ask the EU regulator to recommend conditional approval for its shot.


U.S. drugmaker Pfizer and Germany’s BioNTech reported final trial results on Nov. 18 that showed their vaccine candidate was 95% effective in preventing COVID-19, with no major safety concerns, raising the prospect of U.S. and European approval as early as December.

The European filing completes the so-called rolling review process, which was initiated with the EMA on Oct. 6.

The British government said last week that the US-German partners had reported the data from their clinical trials to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

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The UK has access to a total of 357 million doses of vaccines from 7 different developers.

This includes 40 million doses of BioNTech and Pfizer’s Covid-19 vaccine.

NHS hospitals have been told to be ready to deploy a coronavirus vaccine from as early as Wednesday this week, according to sources speaking to The Daily Telegraph.

Sources said trusts ‘have been asked to mobilise’, amid widespread anticipation that the Pfizer vaccine will get regulatory approval this week.





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Coronavirus COVID-19 Delhi The Buzz

Govt exploring modalities of emergency authorisation of COVID-19 vaccine


New Delhi, November 22

The government is exploring the modalities of emergency authorisation and usage of anti-coronavirus vaccines pending completion of phase-three clinical trial and regular licensure.

The issue of advance purchase commitment for vaccines, including pricing, was also discussed in a recent meeting attended by NITI Aayog Member (Health) Vinod Paul, Principal Scientific Adviser to the government K Vijay Raghavan and Union Health Secretary Rajesh Bhushan.

“It was decided that the PMO-constituted Vaccine Task Force (VTF) will lay down the principles for emergency use authorisation while the National Expert Group On Vaccine Administration for COVID-19 (NEGVAC) should take the lead in setting the principles for advance market commitment, including vaccine pricing,” a source said.

These developments assume significance against the backdrop of Pfizer seeking emergency use authorisation of its COVID-19 vaccine from the US regulators. Another US-based biotechnology giant, Moderna, said it also intends to apply for an emergency use authorisation (EUA) with the US Food and Drug Administration (USFDA) in the coming weeks.

Meanwhile, five vaccines are under different phases of clinical trials in India. The Serum Institute of India is conducting the phase-three trial of the Oxford-AstraZeneca COVID-19 vaccine, while Bharat Biotech and ICMR has already started the phase-three trial of the indigenously developed COVAXIN jab.

An indigenously developed vaccine by Zydus Cadila has completed phase-two clinical trial in the country. Dr Reddy’s Laboratories will soon start combined phase two and three trials of the Russian COVID-19 vaccine Sputnik V in India.

According to the source, an urgent meeting of the vaccine task force (VTF) with experts will be convened to review the scientific status of vaccines globally and whether, if so how and when should the decision on emergency authorisation of vaccines be taken.

The terms of references for two major bodies dealing with vaccine introduction—the National Technical Advisory Group on Immunisation (NTAGI) and the Central Drug Standards and Control Organisation (CDSCO) — will be set and their roles clearly defined for authorisation and emergency authorisation.

It was also agreed at the meeting that one point of contact will be responsible for examining and responding to authorisations given (or in the pipeline), globally, the source said.

Towards advance market commitment, NEGVAC should lay down principles for procurement and price negotiations. Using these principles, negotiations should be speedily initiated.

It was also decided at the meeting that a NEGVAC group should be proactively reaching out to each company as their results from phase three are announced, a source said.

Pfizer and its German partner BioNTech have announced that its vaccine appears 95 per cent effective at preventing mild to severe COVID-19 disease in a large, ongoing study. Moderna has also announced that its COVID-19 vaccine has shown to be 94.5 per cent effective in preventing the deadly disease. — PTI

 





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The Buzz

Pfizer ends COVID-19 trial with 95% efficacy, to seek emergency-use authorisation


November 18

Pfizer Inc said on Wednesday that final results from the late-stage trial of its COVID-19 vaccine show it was 95 per cent effective, adding it had the required two-months of safety data and would apply for emergency US authorisation within days.

The drugmaker said efficacy of the vaccine developed with German partner BioNTech SE was consistent across age and ethnicity demographics, and that there were no major side effects, a sign that the immunization could be employed broadly around the world.

Efficacy in adults over 65 years, who are at particular risk from the virus, was over 94 per cent.

The final analysis comes just one week after initial results from the trial showed the vaccine was more than 90 per cent effective.

Moderna Inc on Monday released preliminary data for its vaccine, showing similar effectiveness.

The better-than-expected data from the two vaccines, both developed with new technology known as messenger RNA (mRNA), have raised hopes for an end to a resurgent pandemic that has killed more than 1.3 million people globally and wreaked havoc upon economies and daily life.

However, while some groups such as healthcare workers will be prioritized in the United States for vaccinations this year, it will be months before large-scale rollouts begin.

Pfizer said on Wednesday there had been 170 cases of the disease in its trial of more 43,000 volunteers, of which 162 were observed in the placebo arm and 8 were in the vaccine group.

Ten people developed severe COVID-19, one of whom received the vaccine.

It also said the vaccine was well-tolerated and that side effects were mostly mild to moderate and cleared up quickly.

The only severe adverse event that affected more than 2 per cent of those vaccinated was fatigue, which affected 3.7 per cent of recipients after the second dose. Older adults tended to report fewer and milder solicited adverse events following vaccination.

The results come as the virus is running rampant in the United States, Europe and elsewhere, placing an enormous strain on healthcare systems with record numbers of new cases and hospitalizations.

The approach of winter in the northern hemisphere in tandem with the holiday season is expected to worsen case numbers as people spend more time indoors and get together for family gatherings.

“With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world,” Pfizer CEO Albert Bourla said in a statement.

Pfizer and BioNTech also said they plan to submit the data to other regulatory agencies around the world as well as the United States. They also plan to submit data from the study to a peer-reviewed scientific journal.

Pfizer reiterated it expects to make as many as 50 million vaccine doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

Of the dozens of drugmakers and research groups racing to develop vaccines against COVID-19, the next data release will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year. — Reuters 





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The Buzz

Pfizer completes COVID-19 trial with 95% efficacy, to seek emergency-use authorisation


November 18

Pfizer Inc said on Wednesday that final results from the late-stage trial of its COVID-19 vaccine show it was 95 per cent effective, adding it had the required two-months of safety data and would apply for emergency US authorisation within days.

The drugmaker said efficacy of the vaccine developed with German partner BioNTech SE was consistent across age and ethnicity demographics, and that there were no major side effects, a sign that the immunization could be employed broadly around the world.

Efficacy in adults over 65 years, who are at particular risk from the virus, was over 94 per cent.

The final analysis comes just one week after initial results from the trial showed the vaccine was more than 90 per cent effective.

Moderna Inc on Monday released preliminary data for its vaccine, showing similar effectiveness.

The better-than-expected data from the two vaccines, both developed with new technology known as messenger RNA (mRNA), have raised hopes for an end to a resurgent pandemic that has killed more than 1.3 million people globally and wreaked havoc upon economies and daily life.

However, while some groups such as healthcare workers will be prioritized in the United States for vaccinations this year, it will be months before large-scale rollouts begin.

Pfizer said on Wednesday there had been 170 cases of the disease in its trial of more 43,000 volunteers, of which 162 were observed in the placebo arm and 8 were in the vaccine group.

Ten people developed severe COVID-19, one of whom received the vaccine.

It also said the vaccine was well-tolerated and that side effects were mostly mild to moderate and cleared up quickly.

The only severe adverse event that affected more than 2 per cent of those vaccinated was fatigue, which affected 3.7 per cent of recipients after the second dose. Older adults tended to report fewer and milder solicited adverse events following vaccination.

The results come as the virus is running rampant in the United States, Europe and elsewhere, placing an enormous strain on healthcare systems with record numbers of new cases and hospitalizations.

The approach of winter in the northern hemisphere in tandem with the holiday season is expected to worsen case numbers as people spend more time indoors and get together for family gatherings.

“With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world,” Pfizer CEO Albert Bourla said in a statement.

Pfizer and BioNTech also said they plan to submit the data to other regulatory agencies around the world as well as the United States. They also plan to submit data from the study to a peer-reviewed scientific journal.

Pfizer reiterated it expects to make as many as 50 million vaccine doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

Of the dozens of drugmakers and research groups racing to develop vaccines against COVID-19, the next data release will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year. — Reuters 





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Delhi The Buzz

Emergency use authorisation for COVID-19 vaccine to depend on clinical trial data: Vardhan


New Delhi, October 11

Union Health Minister Harsh Vardhan on Sunday has said the government has not yet taken a view on granting emergency authorisation to COVID-19 vaccines in India, as and when they become available.

The Minister also said the FELUDA paper strip test for SARS-CoV-2 diagnosis could be rolled out in the next few weeks.

Presently, COVID-19 vaccines are in various stages of phases 1, 2 and 3, the results of which were awaited, Vardhan said during an interaction with his social media followers on ‘Sunday Samvad’ platform.

Also read: Chandigarh, Maharashtra use less than 50% of COViD-19 grant: Harsh Vardhan

“Adequate safety and efficacy data is required for emergency use authorisation, vaccine approval for ensuring patient safety. Further course of action will depend on the data generated,” he underlined.

Categorically denying the speculation that the government was prioritising the young and working-class for the COVID-19 vaccine for economic reasons, Vardhan said: “The prioritisation of groups for COVID-19 vaccine shall be based on two key considerations — occupational hazard and risk of exposure to infection, and the risk of developing severe disease and increased mortality.”

On the issue of how the government plans to roll out the COVID-19 vaccine, he said that it was anticipated that supplies of vaccines would be available in limited quantities in the beginning.

“In a huge country like India, it is critical to prioritise vaccine delivery based on various factors such as the risk of exposure, comorbidity among various population groups, the mortality rate among COVID-19 cases and several others,” the Minister said.

He also added that India was looking at the availability of several different types of vaccines, of which some may be suitable for a particular age group while others may not be.

He reiterated that the most important component of the planning was the cold chain and other logistics to ensure no glitches occur in vaccine delivery even at the last mile.

Vardhan highlighted the need for massive advocacy for building community sensitisation activities to understand the reasons for vaccine hesitancy and address them appropriately.

On the rollout of the FELUDA test in the near future, he said that based on tests in over 2,000 patients during the trials at the Institute of Genomics and Integrative Biology (IGIB) and testing in private labs, the test showed 96 per cent sensitivity and 98 per cent specificity.

This compared favourably to the ICMR’s current acceptation criteria of the PER CENTR Kit of at least 95 per cent sensitivity and at least 99 per cent specificity, he stated.

He added that the FELUDA paper strip test for SARS-CoV-2 diagnosis had been developed by the CSIR-IGIB and had been approved by the Drug Controller General of India for a commercial launch.

“The kit has already been validated by the Department of Atomic Energy’s National Centre for Biological Sciences, Bangalore. While I cannot put an exact date on the availability, we should expect this test within the next few weeks,” he said.

Referring to the reports of reinfection surfacing in various states, Vardhan said an analysis by the ICMR had revealed that many cases reported as COVID-19 reinfection had been misclassified because PER CENTR tests can detect dead-virus shed for prolonged periods after recovery.

“Actual reinfection would mean a fully-recovered person getting infected by a freshly introduced virus in his or her body, belonging to the same or different strain. The ICMR is commissioning a study to understand the true burden of re-infected cases. Results will be shared in a couple of weeks,” he said. PTI





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