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FDA panel recommends 3rd dose of Pfizer vaccine for those over 65, at high risk

The FDA panel has decided not to recommend a third dose of the Pfizer COVID-19 vaccine for everyone who has had two shots, but will vote on recommending it for some high-risk groups. File Photo by Debbie Hill/UPI
The FDA panel has decided not to recommend a third dose of the Pfizer COVID-19 vaccine for everyone who has had two shots, but will vote on recommending it for some high-risk groups. File Photo by Debbie Hill/UPI | License Photo

Sept. 17 (UPI) -- A Food and Drug Administration panel voted Friday to recommend a third dose of Pfizer's COVID-19 vaccine for those over age 65, health care workers and people at high risk for occupational exposure to the virus.

An FDA official said those at high risk most likely would include teachers and essential infrastructure workers.

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The agency's Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend that the FDA approve the booster for everyone at least 16 years old who meets that criteria.

The FDA proposed, and the panel agreed, that approval for the so-called booster shot would come initially as an emergency use authorization, subject to final approval when more safety and efficacy data is available.

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Since the proposal came from the FDA, the agency is very likely to approve the recommendation, though a spokesman said that the plan might be tweaked.

The Advisory Committee for Immunization Practices will meet next week to advise the Centers for Disease Control and Prevention how to apply the FDA's eventual approval.

The CDC scheduled a meeting of its vaccine advisers for next Thursday and Friday. The CDC must approval any booster doses given under the authorization.

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On Friday, the FDA panel reviewed the latest clinical data from Pfizer about the vaccine, which has been administered to tens of millions of people so far, and heard advice from outside advisers. The CDC also provided input.

The vote is non-binding, but the FDA typically acts on the committee's recommendations. The agency will decide afterward if it should formally change approval guidance for Pfizer's coronavirus vaccine, which received emergency authorization in December and full approval last month.

Earlier this week, a group of FDA scientists said a third dose of Pfizer's vaccine almost certainly increases antibodies in recipients and offers greater protection against COVID-19. However, they stopped short of saying the extra dose is needed by a majority of Americans.

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Though the Biden administration said it hopes to begin providing booster shots by next week, experts on Friday they're likely not necessary yet because even with waning immunity, the two-shot regime of Pfizer still largely protects against severe cases of COVID-19.

In August, U.S. health officials said they wanted to make a third dose of the Pfizer vaccine available starting Monday, mainly as a result of the Delta coronavirus variant, which is more infectious than the original strain.

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"It's unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease," said Dr. Michael Kurilla, a member of the FDA advisory committee and a National Institutes of Health official.

Some studies suggest the Pfizer vaccine declines in effectiveness over time, and other research indicates that it does not. FDA scientists have also said they're looking at studies from Israel that have shown decreasing effectiveness.

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