The U.S. Food and Drug Administration (FDA) is working toward quickly finalizing and issuing emergency approval for Pfizer and BioNTech’s coronavirus vaccine candidate, according to top FDA officials.
“Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” Dr. Stephen Hahn, FDA commissioner, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a joint statement released Friday.
“The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” the statement continues.
Meanwhile, Health and Human Services Secretary Alex Azar told ABC’s “Good Morning America” on Friday the FDA “informed Pfizer that they do intend to proceed toward an authorization” in the next few days. “We could be seeing people getting vaccinated Monday, Tuesday of next week.”
The comments came after an advisory panel on Thursday voted 17-4 to endorse Pfizer’s vaccine. One committee member abstained. The vote cleared the way for FDA leaders to authorize emergency mass distribution amid an ongoing surge of COVID-19 cases across the country.
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?”
Some members argued against the vaccine’s approval for use among 16- and 17-year-olds due to limited evidence, while others said teens wouldn’t be among the first to receive the vaccine, allowing for time to research the effects it may have on this age group.
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.
The panel’s decision on Thursday was not final; it awaits review and confirmation by the officials with the Center for Biologics Evaluation and Research.
Late-stage clinical trials showed Pfizer’s vaccine was 95% effective against COVID-19 disease, and documents posted ahead of the agency’s scheduled Dec. 10 meeting showed the candidate met FDA’s requirements for emergency use authorization (EUA). The documents did not flag any new concerns or safety issues regarding the vaccine after reviewing the submitted data.
Fox News’ Madeline Farber and Alexandria Hein and Fox Business contributed to this report.
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