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What to expect as FDA advisory panel debates Pfizer COVID booster shots

The Food and Drug Administration’s independent advisory committee will convene 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’s necessary and effective at improving protection levels against COVID-19.

Their vote will be non-binding — the FDA is not required to follow the Vaccines and Related Biological Products Advisory Committee’s (VRBPAC) recommendations — but they generally do so.

After that vote, the FDA will decide whether they will formally amend their current vaccine approval for Pfizer. Next week the matter heads to the Centers for Disease Control and Prevention’s independent advisory panel (ACIP), where that panel will weigh on a more granular level who should get a booster and when? The CDC director will then formally sign off on whatever ACIP recommends.

Friday morning’s opening remarks are set to kick off at 8:30 a.m. ET, followed by introductions by the FDA, presentations from CDC representatives, a discussion about booster protection and a presentation from Pfizer executives who will make the case for why boosters are appropriate.

After a public hearing portion in the afternoon and a question-and-answer session on both Pfizer’s and the FDA’s presentations, the committee will debate the issue for roughly two hours. A vote is expected at about 4:45 p.m. ET, if they stay on schedule.

Two top FDA officials who are leaving the agency later this year publicly waded into the debate on Monday, splitting from the agency and arguing in a scientific journal that it was too soon to give booster shots to the general public since the vaccines still offer strong protection against serious disease.

Both are scheduled to attend Friday’s discussion. One of them, the director of the agency’s office of vaccines research and review, is supposed to give an overarching introduction of the topic for the FDA in the beginning of the day.

Also joining Friday’s meeting is the head of Israel’s public health services, Dr. Sharon Alroy Preis, who is set to present data on booster protection against COVID infection and severe disease.

In a review of Pfizer’s data, also released Wednesday, the FDA appeared to be noncommittal on the necessity for boosters. The agency pointed out that Pfizer’s efficacy data could be hampered by the limitations of studying boosters in real-world situations, which can introduce complicating factors.

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

Naming no one — but nodding to those lingering concerns — Pfizer’s CEO Albert Bourla penned an open letter on Thursday making the case for booster shots.

“This week we are approaching another pivotal moment in our ongoing fight against the virus,” Bourla writes of Friday’s FDA advisory committee. “Since the start of this pandemic, Pfizer and BioNTech have pledged to follow the science and keep people informed about our progress to help bring an end to this global health crisis. We have stayed true to our commitment of full transparency without selectively cherry-picking data.”

https://notes.io/JqrR

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