Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data | The BMJ

Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data | The BMJ: Transparency advocates have criticised the US Food and Drug Administration’s (FDA) 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 (VRBPAC) 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 FDA also has held meetings of the VRBPAC on all three covid-19 vaccines authorised for emergency use and does not believe a meeting is needed related to this biologics license …