The FDA's independent advisory committee is convening to review 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.
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 theBoth 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.
"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.
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