FDA schedules adcomm for Pfizer’s COVID booster filing

The FDA will hold an advisory committee meeting later this month to discuss Pfizer and BioNTech’s filing for approval of a third booster dose of their COVID-19 vaccine Comirnaty in people aged 16 and over.

The adcomm is scheduled for 17 September and will consider the Pfizer/BioNTech filing as well as booster doses more generally. The news comes as Moderna has just announced the submission of initial data to the FDA for its own COVID-19 vaccine booster.

Whether expert meetings will be needed for other vaccines will depend on the data received by their manufacturers, and if it raises “unique questions that would benefit from the committee’s input”, said Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation (CBER).

The meeting has been announced shortly after two of the FDA’s senior vaccine staff – Dr Marion Gruber and Dr Philip Krause – said they would be stepping down in the autumn, reportedly in protest at the US government’s recent announcement of a booster campaign prior to an FDA ruling.

“The administration recently announced a plan to prepare for additional COVID-19 vaccine doses … and a key part of that plan is FDA completing an independent evaluation and determination of the safety and effectiveness of these additional vaccine doses,” according to Marks, who will replace Gruber as head of the Office of Vaccines Research and Review on an interim basis while a successor is sought.

“A transparent, thorough and objective review of the data by the FDA is critical so that the medical community and the public continue to have confidence in the safety and effectiveness of COVID-19 vaccines,” he added.

Pfizer and BioNTech said last week they had started a ‘rolling’ marketing application for a third dose of Comirnaty, after President Joe Biden announced plans to make boosters available this month to any adult American who has been fully vaccinated at least eight months ago.

The FDA has already issued an emergency use authorisation (EUA) for third doses of the Pfizer/BioNTech and Moderna jabs, but only for people with compromised immune systems. Several other countries, including the UK, have said they will start booster campaigns only in vulnerable populations.

The White House has insisted that any booster campaign will only start after the FDA review, but its decision to make a public announcement ahead of the regulator’s verdict has been criticised as a move intended to raise political capital.

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