Why did the FDA not hold the expected public meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), to review the latest data prior to this approval? The last public meeting was in October 2020. In the intervening 10 months, tens (hundreds?) of millions of doses of EUA vaccine were administered, generating an enormous data set which has not been through VRBPAC review,
https://www.bmj.com/content/374/bmj.n2086> Transparency advocates have criticised the ... (FDA) decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine ... Kim Witczak ... a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, said the decision removed an important mechanism for scrutinising the data ... "The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinised in advance of an approval" ... She warned that without a meeting “we have no idea what the data looks like.”
“It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years,” she said. “There is no control group after Pfizer offered the product to placebo participants before the trials were completed. “Full approval of covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals.”
... Joshua Sharfstein ... former FDA deputy commissioner during the Obama administration, said that advisory committee meetings were more than just a way of receiving scientific input from outside experts. “It’s also an opportunity to educate the public about the important work that the FDA has done reviewing an enormous amount of data about a product,” he told The BMJ. “It’s a chance for questions to be asked and answered, building public confidence."