A U.S. Food and Drug Administration advisory committee on Thursday voted to approve Pfizer and BioNTech’s emergency use authorization (EUA) application for its coronavirus vaccine candidate, the first COVID-19 jab to win such approval in the U.S.
The vote was 17-4. One committee member abstained.
The committee was charged with voting on the following question: “Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risk for use in individuals 16 years of age and older?”
Several committee members took issues with the aspect of approving the vaccine for use in 16- and 17-year-olds due to limited evidence. Others argued that the 16- and 17-year-olds wouldn’t be among the first to receive the vaccine, allowing for time to research the effects it may have on this age group.
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The highly anticipated meeting included members of the FDA’s Center for Biologics Evaluation and Research advisory committee, outside vaccine experts and Pfizer representatives. The U.S. follows behind Canada, the United Kingdom and Bahrain to approve the emergency use of Pfizer and BioNTech’s coronavirus vaccine.
Albeit significant, it’s important to note that the committee’s vote in favor of the EUA is not final; the vote now has to be reviewed by the officials with the Center for Biologics Evaluation and Research, which will confirm the decision.
(A similar process ensued after a panel of independent experts advising the Centers for Disease Control and Prevention (CDC) voted last week that health care workers and residents of long-term care facilities will be the first to receive the long-awaited coronavirus vaccine. That decision required approval from CDC Director Dr. Robert Redfield.)
The vaccine proved 95% effective in late-stage clinical trials, the companies announced late last month. Pfizer and BioNTech were the first to apply for emergency use authorization from the FDA. Another efficacious vaccine candidate developed by Moderna followed suit, becoming the latest contender to file for EUA.
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The FDA vote to approve the companies’ EUA was expected, with documents posted ahead of the agency’s scheduled Dec. 10 meeting showing that the candidate met the FDA’s requirements for emergency use.
The documents did not flag any new concerns or safety issues regarding the vaccine after reviewing the submitted data.
The agency found no specific safety concerns among subgroup analyses but did list several unknowns that will need to be investigated further, including duration of immunity, efficacy in certain high-risk populations, those previously infected, as well as effectiveness among asymptomatic infection, long-term effects of COVID-19 disease, mortality and transmission of SARS-CoV-2.
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Fatigue, headache, muscle pain, chills, joint pain and fever were all listed as reported adverse reactions but were categorized as mild to moderate. Serious adverse events remained uncommon and “represented medical events that occur in the general population at similar frequency as observed in the study.”
That said, in the U.K., at least two adverse reactions occurred on the first day of the country’s mass vaccination program that began this week, leading regulators in the country to advise that people who have a “significant history” of allergic reactions should avoid receiving the new Pfizer-BioNTech vaccine at this time.
Fox News’ Alexandria Hein and Kayla Rivas, and the Associated Press contributed to this report.