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FDA panel rejects plan to administer Pfizer's Covid booster doses to general public

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Scientists continued debating the need for a third dose of the vaccines for older Americans, leaving open the possibility of other votes.
An influential Food and Drug Administration advisory committee on Friday resoundingly rejected a plan to administer booster shots of Pfizer and BioNTech’s Covid-19 vaccine to the general public, saying they needed more data. The panel, however, could still clear the shots for older populations. Scientists continued debating the need for a third dose of the vaccines for older populations after their initial vote, leaving open the possibility of other votes. „It’s likely beneficial, in my opinion, for the elderly, and may eventually be indicated for the general population. I just don’t think we’re there yet in terms of the data,“ Dr. Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital, said after voting against the original proposal. The final tally failed 16-2. Pfizer’s stock was down more than 1% in intraday trading after the initial vote. Shares of BioNTech were down more than 4%. The nonbinding decision by the FDA’s Vaccines and Related Biological Products Advisory Committee comes as the Biden administration has said it wants to begin offering booster shots to the general public as early as next week, pending authorization from U.S. health regulators. While the agency hasn’t always followed the advice of its committee, it often does. A final FDA decision could come in a matter of hours. The Centers of Disease Control and Prevention has scheduled a two-day meeting next week to discuss plans to distribute the third shots in the U.S. The committee vote was expected to be a controversial one as some scientists, including two senior FDA officials who were involved in the meeting Friday, have said they aren’t entirely convinced every American who has received the Pfizer vaccine needs extra doses right now. In a paper published days before the advisory committee meeting, a leading group of scientists said available data showed vaccine protection against severe disease persists, even as the effectiveness against mild disease wanes over time. The authors, including two high-ranking FDA officials and multiple scientists from the World Health Organization, argued Monday in the medical journal The Lancet that widely distributing booster shots to the general public is not appropriate at this time.

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