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What To Expect As FDA Advisory Panel Debates Pfizer COVID Booster Injections

The group will discuss and vote on whether to recommend Pfizer booster injections.

The Food and Drug Administration’s independent advisory committee will meet in open session Friday to review the latest data submitted by Pfizer and discuss whether a booster dose is safe enough for widespread use and whether it is necessary and effective. to improve levels of protection against COVID-19.

Their vote will be non-binding – the FDA is not required to follow the recommendations of the Advisory Committee on Vaccines and Related Biologics (VRBPAC) – but they generally do.

After this vote, the FDA will decide whether to officially change its current vaccine approval for Pfizer. Next week, the question heads to the Centers for Disease Control and Prevention’s (ACIP) independent advisory group, where that group will weigh in on a more granular level. Who should receive a reminder and when? The CDC director will then formally sign anything that ACIP recommends.

Friday morning’s opening remarks are expected to begin at 8:30 a.m. ET, followed by introductions by the FDA, presentations from CDC officials, a discussion on recall protection, and a presentation from Pfizer executives who explain why reminders are appropriate.

After a part of public hearing in the afternoon and a question-and-answer session on the presentations from Pfizer and the FDA, the committee will debate the matter for approximately two hours. A vote is scheduled for around 4:45 p.m. ET, if they stick to the schedule.

The two are expected to attend Friday’s discussion. One of them, the director of the agency’s office of vaccine research and review, is supposed to do a comprehensive introduction to the topic for the FDA at the start of the day.

Israel’s head of public health, Dr Sharon Alroy Preis, will also join Friday’s meeting, which is expected to present data on enhanced protection against COVID infection and serious illness.

In a review of Pfizer’s data, also released on Wednesday, the FDA appeared not to commit to the need for boosters. The agency pointed out that Pfizer’s efficacy data could be hampered by the limitations of studying boosters in real-life situations, which may introduce complicating factors.

“There are many potentially relevant studies, but the FDA has not independently reviewed or verified the underlying data or their findings,” the agency wrote in its briefing.

Not naming anyone – but nodding at these lingering concerns – Pfizer CEO Albert Bourla wrote an open letter on Thursday arguing for the booster injections.

“This week, we approach another pivotal moment in our ongoing fight against the virus,” Bourla wrote of the FDA advisory panel on Friday. “Since the start of this pandemic, Pfizer and BioNTech have been committed to following the science and keeping people informed of our progress to help end this global health crisis. We have stuck to our commitment to full transparency without selectively sorting. The data. “

Sony Salzman, Eric M. Strauss, and Cheyenne Haslett of ABC News contributed to this report.