The BMJ.Transparency advocates have criticised the US Food and Drug Administration's decision not to hold a formal advisory committee meeting to discuss Pfizer's application for full approval of its covid-19 vaccine.
Last year the FDA said it was "Committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public."1 But in a statement, the FDA told The BMJ that it did not believe a meeting was necessary ahead of the expected granting of full approval.
"The FDA has held numerous meetings of its Vaccines and Related Biological Products Advisory Committee related to covid-19 vaccines, including a 22 October 20202 meeting to discuss, in general, the development, authorisation, and licensure of covid-19 vaccines," an FDA spokesperson said.
The spokesperson added, "The Pfizer BioNTech covid-19 vaccine was discussed at the VRBPAC meeting on 10 December 2020.3 If the agency had any questions or concerns that required input from the advisory committee members we would have scheduled a meeting to discuss."
"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."
Public discussionDiana Zuckerman, president of the National Center for Health Research, who has also spoken at recent VRBPAC meetings, told The BMJ, "It's obvious that the FDA has no intention of hearing anyone else's opinion.
Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health and 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.
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