(Reuters) – The U.S. Food and Drug Administration’s outside advisers will meet on Dec. 10 to discuss whether to authorize the COVID-19 vaccine developed by Pfizer Inc and German partner BioNTech for emergency use, the agency said yesterday.
The move comes after Pfizer applied for the authorization of its COVID-19 vaccine earlier in the day, the first such application in a major step toward providing protection against the new coronavirus.
“While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible,” FDA Commissioner Stephen Hahn said in a statement.
The meeting of Vaccines and Related Biological Products Advisory Committee will discuss the safety and effectiveness of the vaccine candidate.
The FDA is not obligated to abide by its advisory panel recommendations, but typically does. (https://bit.ly/3nDK4Ta)
Reuters had reported, citing a source, that an FDA panel tentatively plans to meet between Dec. 8 and 10 to discuss the vaccine.
Hahn said the agency has been preparing for the review of emergency use authorization for COVID-19 vaccines for several months and stands ready to do so as soon as a request is submitted.
The FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting.
