Source: FDA is likely to make a booster decision without an external advisory committee weighing in

Pfizer used to the FDA for Emergency Use Permit on Nov. 9 to make all adults eligible for boosters. The processing of this request could be faster if the Agency does not wait for members of the Vaccines and Related Biological Products Advisory Committee to meet.

Allowing boosters for all adults has been controversial, as some FDA vaccine advisors are concerned about the risk of myocarditis – inflammation of the heart muscle – a rare side effect that mainly occurs in young men.

The source said “it is unlikely there will be a meeting” with the external advisers and that “there has been no discussion of a meeting” to discuss Pfizer’s application.

In a statement, the FDA said the agency “will decide whether to hold a meeting of the advisory committee … after its initial review of the information submitted.”

When the FDA’s vaccine advisory panel met last month, the chairman of the committee seemed to lay the groundwork for the group not to meet again every time a booster eligibility decision had to be made.

Dr. Arnold Monto, the acting chairman of the advisory committee, asked an FDA official who was present “about how we can get a little more flexibility so we don’t have to meet and discuss every time we want to go down in age group. ”

Monto added in an interview with CNN that as new booster data comes in, more steps need to be taken to recall the committee.

What is the best booster to get?  And other questions about Covid-19 boosters

“In a dynamic situation, it’s very cumbersome to be summoned – we have to be screened every time for conflicts of interest and everything else that is needed to hold a meeting – all the legal stuff,” he said. “Our role is to advise on overall policy and to leave the details to the FDA, because one, we are advisory, and two, we can not, as we are set up, react quickly to changing circumstances.”

If the FDA approves boosters for all adults, the U.S. Centers for Disease Control and Prevention’s external panel of vaccine advisors will meet to review the plan, a federal official said.

“If the FDA approves it, [the Advisory Committee on Immunization Practices] will meet as they have met for everything about Covid vaccines since the beginning of December 2020, “the official said.

CDC Director, Dr. Rochelle Walensky, would have to sign the Agency’s final recommendation.

“Dr. Walensky supports the use of vaccine boosters to protect Americans from COVID-19 when medically necessary, and is eagerly awaiting the opportunity to review data related to Pfizer boosters for those 18 years and older,” said a spokesman for CDC to CNN in an email. “Any decision will come after a thorough review of the science and consultation with internal and external advisors.”

A rocky start

Boosters has had a rock-solid start in the United States.

In mid-August, President Joe Biden announced “a booster shot plan for all fully vaccinated [adult] American. “He said that pending approval from the FDA and the US Centers for Disease Control and Prevention, the booster program would begin in the week of September 20th.
At least 89% of vaccinated U.S. adults will qualify for Covid-19 booster shots

A few days later, Pfizer sought FDA approval for booster doses for anyone 16 years of age and older who was at least six months after their second shot.

But vaccine advisers protested, and instead the FDA approved Pfizer boosters for a more limited group of adults who are six months after their second shot, including the elderly and those at high risk of developing severe Covid-19. The FDA also approved boosters for Moderna vaccine recipients in these categories and for all Johnson & Johnson recipients.

In it minutes at a meeting of the FDA Vaccine Advisory Committee last month, it was noted that “many” of the advisors were “uncomfortable” in lowering the age of boosters under 40 or 50, “until more data on myocarditis are available.”

Dr. Paul Offit, a member of the FDA Vaccine Advisory Committee, said it would be best for the FDA and CDC to bring Pfizer’s current application to their advisors.

“I think we need to be transparent about this decision, and the best way for us to be transparent is to hold meetings of advisory committees at both the FDA and the CDC so that the public can hear the discussion of why it is an important thing. to do, “he said.

He added that at these meetings, which are public, the data could be interpreted.

“I think we need to show why a booster dose is clearly beneficial for 18-29 year olds, because if it is not clearly beneficial, we need to consider that myocarditis was another dose phenomenon and “can also be a third. dosing phenomenon. Do the benefits clearly and definitely outweigh the risks for 18-29 year olds?” said Offit.

Monto, acting chairman of the FDA Vaccine Committee, said there is a precedent that the FDA chooses not to consult the Vaccine Advisory Committee on certain decisions.

He said members of the committee meet “at the discretion of the FDA. They are only advisory and there is a history of [the committee] not meet on points where the FDA does not feel they need the committee’s advice. “

CNN’s Amanda Sealy, Danielle Herman and Justin Lape contributed to this report.

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