October 26, 2021

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FDA Panel Rejects Plan To Administer Pfizer’s COVID-19 Booster Doses To General Public

FDA Panel Rejects Plan To Administer Pfizer’s COVID-19 Booster Doses To General Public
An anonymous reader quotes a report from CNBC: 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 recommend the shots for other populations. Scientists continued debating the need for a third dose of the vaccines for people 65 and older and other vulnerable populations after their initial vote. “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.

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. In outlining plans last month to start distributing boosters as early as next week, administration officials cited three CDC studies that showed the vaccines’ protection against Covid diminished over several months. Senior health officials said at the time they worried protection against severe disease, hospitalization and death “could” diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout. Before the vote, some committee members said they were concerned that there wasn’t enough data to make a recommendation, while others argued third shots should be limited to certain groups, such as people over age 60 who are known to be at higher risk of severe disease. Some members raised concerns about the risk of myocarditis in younger people, saying more research is needed.

Read more of this story at Slashdot.