Pfizer/BioNTech ’s COVID-19 Vaccine Gets a Major Endorsement from FDA Committee
In a 17-4 vote (with one abstention) the U.S. Food and Drug Administration’s (FDA) vaccine advisory committee recommended that Pfizer/BioNTech’s COVID-19 vaccine should be distributed to the American public.
With that recommendation hand, an FDA team led by the agency’s commissioner Dr. Stephen Hahn will now make a final decision about whether to issue an emergency use authorization (EUA) for the vaccine for anyone 16 years and older. The committee vote is not binding, but the agency is likely follow its advice, especially given the urgent need for a vaccine to stave off a rising tide of new infections. The FDA decision could happen at any time.
“We have been looking forward to presenting our robust data package to the committee of vaccine experts for the U.S. 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 vote, and if the FDA issues an authorization, stand at the ready to bring this vaccine to people in the U.S. in an effort to help combat this devastating pandemic.”
Bourla has said the company is ready to begin shipping doses within hours of an EUA issuance. The vaccine has already received approval in the UK and health officials began vaccinating people there on Dec. 8; it has also been approved in Canada, where the first shots are expected next week.
During the day-long meeting of the FDA’s...
Source: TIME: Health - Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 Source Type: news
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