Third dose Pfizer, September 17 FDA meeting

Third dose of Pfizer vaccine, the American Food and Drug Administration announced a virtual meeting of the Advisory Committee on Vaccines and Related Biological Products for Friday 17 September to discuss the issue of Covid vaccine booster doses. The comparison, scheduled from 8.30 to 15.45 local time (in Italy 11.30-21.45), will concern in particular the request for additional authorization made by Pfizer / BioNTech for the administration of a third dose of the mRna Comirnaty * vaccine in people aged equal to 16 or higher. The meeting will be broadcast by the FDA on the institution’s website and YouTube channel. “The administration recently announced a plan to prepare for the administration of additional doses of the Covid-19 vaccine this fall – explains Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (Cber) – and a key part of this. plan is the completion of an independent evaluation and the agency’s determination of the safety and efficacy of these additional doses. “The process” for authorizing a possible booster dose, Marks points out, “requires each vaccine manufacturer submit safety and efficacy data to the agency to support this use. The FDA is evaluating the data submitted by Pfizer-BioNTech “in its application and” will discuss it with its advisory committee. ” “A transparent, in-depth and objective review of the data by the FDA – remarks the director of the Cber – is essential for the medical community and the public to continue to have confidence in the safety and efficacy of Covid-19 vaccines. The FDA will examine the request “of the US pharmaceutical company and its German partner” as quickly as possible, while continuing to do so in a thorough and science-based manner. “