FDA panel votes for Pfizer Covid vaccine to receive emergency authorisation

Majority of experts on the 23-person panel voted in favour of approving the vaccine for emergency use 

Danielle Zoellner
New York
@dani__zoellner
Friday 11 December 2020 01:05
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The 23-person independent panel commissioned by the Food and Drug Administration (FDA) has voted to approve Pfizer’s coronavirus vaccine for emergency use.

Each member of the Vaccines and Related Biological Products Advisory Committee was asked on Thursday if the benefits of Pfizer’s coronavirus vaccine “outweighs its risks for use on individuals 16 years of age or older” based on the “totality of scientific evidence available”. 

The majority of the panel voted in favour of the FDA issuing emergency use authorisation to Pfizer for its vaccine, with 17 experts voting “yes”, four voting “no”, and one expert abstaining from the vote. 

This decision does not mean the FDA will automatically grant emergency use authorisation to the company, but it did indicate that Pfizer could probably receive the approval as early as Friday given the panel vote. 

Pfizer would be the first company to receive emergency use authorisation for its coronavirus vaccine in the United States. Moderna, which is about one week behind Pfizer, has also applied for the authorisation, and an independent panel will review the company’s data on 17 December. 

With this formal blessing for Pfizer’s vaccine from the nation’s leading scientific experts and infectious disease experts, the United States could start its largest vaccination campaign in history as early as this weekend in an effort to protect the public from contracting the novel virus. 

Pfizer indicated it could ship about 2.9 million doses of its vaccine within 24 hours of receiving emergency use authorisation, which would be divided up between the states. An additional 2.9 million doses would then be sent 21 days following the first shipment for the recipients who received the first dose. 

In total, the company said it could ship an estimated 50 million doses by the end of the year, which would vaccinate 25 million Americans. 

Those who are first in line to receive a coronavirus vaccine will likely be frontline healthcare workers and people living in long-term care facilities, based on initial recommendations released by the Centres for Disease Control and Prevention (CDC). 

There are an estimated 21 million healthcare workers and 3 million people living in long-term care facilities. So the initial doses available will not likely go beyond those groups. 

An advisory committee to the CDC will meet on Sunday to discuss their final recommendations for who should be vaccinated first. 

During the FDA’s meeting on Thursday, the independent discussed Pfizer’s coronavirus vaccine data gathered from its clinical trials. Members of the FDA and Pfizer were also available to answer any questions experts had regarding the data. 

A point of contention among experts was including those aged 16 and 17 in the emergency use authorisation. Several paediatricians argued that age group should be excluded from the authorisation given the clinical trials involved limits data on the vaccine’s effects on children. 

Whether the FDA would consider excluding that age group prior to giving Pfizer emergency use authorisation remained unknown. 

Overall, the vast majority of experts were satisfied with the safety and efficacy Pfizer’s vaccine demonstrated during clinical trials, as its data showed the jab was 95 per cent effective against Covid-19. 

But one concern raised was the potential serious allergic reaction someone might experience after receiving the vaccine. Two people in the United Kingdom experienced an allergic reaction after they received Pfizer’s vaccine on Tuesday, according to the National Health Service

Dr Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said he was worried about what this information could mean for the millions of Americans who suffer from severe allergies.

“We don't know the details of those two cases. We don’t know specifically what it was they were allergic to, or what their history with severe allergies was,” Dr Offit said, who was a voting member of the committee.

“There are tens of millions of people in this country who carry EpiPens with them — because they have peanut allergies, because they have egg allergies — who are going to believe now that they can't get this vaccine,” Dr Offit said. “That's a lot of people.”

Pfizer officials said they saw no serious allergic reactions among volunteers who received the vaccine in the company’s clinical trials.

“Amongst the 44,000 subjects, we saw no serious allergic reactions to the vaccine,” Dr William Gruber, senior vice president of vaccine clinical research and development at Pfizer, said.

“Within the clinical trial we've actually not seen evidence to suggest a signal related to allergic reaction to the vaccine,” he added.

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