"The FDA only held one meeting with its advisory panel, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), after Pfizer and BioNTech lodged their BLA request. That meeting focused on whether to clear vaccines for younger populations, and not the new application.
During the meeting, multiple panelists expressed confusion about when they would be consulted on any BLA requests.
“Where are we at with the licensure for adults?” Dr. Archana Chatterjee, one of them, said.
“I’m still unclear when we’re going to be reviewing the BLAs for [adults],” added Dr. Steven Pergram, another.
An FDA official revealed in the June 2021 internal meeting that the agency was planning on not consulting its outside advisers before deciding on Pfizer’s application.
Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, “confirmed that, unless a significant new safety concern or other important issue is discovered during the review of the submission that would necessitate convening the VRBPAC, an Advisory Committee Meeting will not be needed for this BLA,” according to the summary.
The FDA, which has never rejected an EUA or BLA request from Moderna or Pfizer related to their COVID-19 vaccines, and the U.S. Centers for Disease Control and Prevention, made a trend of bypassing the advisory panels during the pandemic, including when they authorized and recommended boosters in the fall of 2022 without any clinical data.
In another portion of the document, as justification for not calling a committee meeting, FDA officials said they had already consulted the advisory committee five times between October 2020 and June 2021 “to discuss the development, Emergency Use Authorization and licensure of COVID-19 vaccines.”
