Pfizer/BioNTech — FDA Advisory Panel Recommends Vaccine Approval for Emergency Use

By Adriaan Brits Friday, December 11, 2020

A group of advisors to the Food and Drug Administration (FDA) voted on Thursday to approve the emergency use of the COVID-19 vaccine developed by Pfizer and BioNTech. Advisers voted 17-4 in favor of authorizing the use of the shot for individuals that are at least 16 years old. Only one member of the committee abstained.

EUA Could Come as Soon as Today

The agency is highly expected to endorse emergency use in the coming days, with the vaccinations and distribution anticipated to begin immediately.

“We have been looking forward to presenting our robust data package to the committee of vaccine experts for the US government since we began our efforts to develop a novel COVID-19 vaccine earlier this year,” said Dr. Albert Bourla, Pfizer Chairman and CEO, in a statement.

“We are pleased with the committee’s strong majority vote, and if the FDA issues an authorization, stand at the ready to bring this vaccine to people in the US in an effort to help combat this devastating pandemic.”

Pfizer has requested approval for its two-dose coronavirus vaccine for emergency use in individuals aged between 16 and 85. At first, there was a discussion among committee members whether 16-year-olds should be included when inoculation begins, resulting in a vote that included individuals of that age.

“This is a historic moment,” Eric Dickson, CEO of UMass Memorial Health Care, said after the voting process finished. Dickson, who was not the member of the panel, said Pfizer’s vaccine is “the best solution to get us out of our current situation and help us save lives.”

A month ago, trial data showed that Pfizer and BioNTech’s two-dose vaccine was 95% effective in preventing the COVID-19.

A Number of Points Discussed

Four members of the committee voted against approving the emergency use and some said the reason for this is because these panel members were feeling uncomfortable with including 16 and 17-year-olds, citing insufficient data from trials.

“The final decision about whether to authorize the vaccine for emergency use will be made by FDA’s career officials,” the FDA added in a statement.

The committee also talked about two reports in the United Kingdom about two individuals that got the shot and had severe allergic reactions. Furthermore, the discussion included women of fertile age who are expected to be among those who will get the shot first.

As for pregnant women, the agency advised they should make their own decision after consulting their doctors as there was not enough data from trials to endorse or contradict the authorization of vaccine use for them.

American volcanologist and a former member of the FDA advisory panel Dr. Gregory Poland said he was surprised the committee did not show more caution when it comes to pregnant women.

During the discussion, the panel also held talks about Pfizer’s plan to let the volunteers who received a placebo during trials to get the shot after making sure they’re eligible under guidelines provided by state and local health representatives.

The drugmaker thinks these volunteers should be able to choose whether they want to get vaccinated after they become eligible.

Documents that the FDA brought before the panel started negotiations did not indicate any new safety problems, boosting hopes that the United States would endorse the emergency use after Canada and Britain.

Health regulators in the UK recommended people who suffered from anaphylaxis, a severe allergic reaction after receiving medicine or food, to avoid getting the shot.

Dr. William Gruber, senior VP of vaccine clinical research and development at Pfizer, said to the committee that his company “saw no serious allergic reactions to the vaccine” among the 44,000 individuals who volunteered in the trials.

Still, an FDA official instructed Pfizer to investigate safety issues related to severe allergic reactions once the vaccine gets approved.

Summary

A panel of FDA advisors voted 17-4 in support of authorizing the emergency use of Pfizer-BioNTech’s coronavirus vaccine after it demonstrated it is 95% effective in preventing the COVID-19. The agency is expected to endorse the use of the shot as soon as possible, after which distribution and inoculations will begin immediately.

About the Author


Headshot for author Adriaan Brits
As an analyst of global affairs, Adriaan has an MSC from Oxford, with diverse interests in the digital economy, entertainment, and business. He is a specialist trainer in Advanced Analytics & Media.

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