FDA Ignores Safety Committee’s Guidance, Authorizes Pfizer Booster for 65 and Older, Plus ‘High Risk’ Groups

By Megan Redshaw

Critics slammed the decision, calling it “unjustified and unethical” and a “consolation prize” for Pfizer, which wanted approval for everyone in the general population, over age 16.

The U.S. Food and Drug Administration (FDA) on Wednesday amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID vaccine to allow for a single booster shot to be administered to people 65 and older.

In addition to older Americans, boosters will be made available to people 18 through 64 years of age at high risk of severe illness from COVID, and also those “whose frequent institutional or occupational exposure” to the virus puts them at high risk of serious complications from the disease caused by the virus, the agency said.

“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as healthcare workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others,” Dr. Janet Woodcock, acting FDA commissioner said in a statement.

The FDA, in approving the emergency authorization, interpreted the advisory panel’s recommendations issued Friday more broadly to cover a larger swath of people.

During meeting of FDA advisory panel to recommend whether to approve 3rd dose of Pfizer’s COVID vaccine, physicians pointed to data that confirms risks of Pfizer’s COVID vaccine don’t outweigh benefits.

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On Sept. 17, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously recommended EUA for a booster dose of Pfizer’s vaccine for people 65 and older and those with compromised immune systems, to be administered six months after they get the first two doses.

However, the committee voted 16 to 2 against recommending boosters for the general population citing a lack of long-term data. The committee said the risks did not outweigh the benefits for those people.

“The FDA considered the committee’s input and conducted its own thorough review of the submitted data to reach today’s decision,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

Pfizer had asked for FDA approval to give its vaccine to everyone 16 and older six months after they are fully immunized with two shots, CNN reported. The company said it had enough evidence that immunity starts to wane after six months, and that giving a booster restores the immunity safely.

As The Defender reported Sept.16, Pfizer didn’t test its booster at all in people who are actually at risk. The company conducted only a single phase 1 study that covered 12 people over age 65.

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Via https://childrenshealthdefense.org/defender/fda-authorizes-pfizer-booster-65-older-high-risk/