Amid meddling concerns, FDA convenes adcomm for Pfizer/BioNTech booster
The FDA’s panel of outside vaccine advisors is set to meet in two weeks and discuss Pfizer and BioNTech’s sBLA application for a third, booster shot of their Covid-19 vaccine — just three days before the Biden administration said it would roll out boosters.
Regulators received the sBLA just a week ago, and they will be looking to those experts to inform their decision making, said CBER chief Peter Marks.
The announcement for the advisory committee, scheduled for Sept. 17, came as Moderna said it’s started the submission process for its own booster. The biotech didn’t specify whether it’s seeking an expanded emergency use authorization or a supplemental approval on the BLA pathway.
The push for boosters came amid concerns that the White House had meddled with the regulatory process by unveiling a nationwide booster campaign ahead of any FDA reviews. The perceived overreach was what, ultimately, contributed to the sudden departures of two top officials who’s been leading the agency’s vaccine review for years, a former senior FDA leader said.
Marks insisted in a statement that the FDA’s “independent evaluation and determination of the safety and effectiveness” of vaccine boosters is a key part of the rollout plan.
“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 said. “The FDA will review the supplemental application as expeditiously as possible, while still doing so in a thorough and science-based manner.”
Pfizer and BioNTech filed for approval based on data from a Phase III study where 306 volunteers received a third dose between 4.8 and 8 months after their second shot and saw “robust” antibodies against the original SARS-CoV-2 strain.
For Moderna, the first batch of data submitted is from a Phase II trial that tested the 50 µg dose. The current Moderna vaccine is a 100 µg dose.