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FDA advisory panel recommends US approval of Pfizer/BioNTech's COVID-19 vaccine

Published on 11/12/20 at 01:48pm

An advisory panel on behalf of the FDA has strongly recommended that Pfizer and BioNTech’s COVID-19 vaccine BNT162b2 be approved for use in patients at least 16 years old.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-4 in favour of the decision, with one abstention.

Concerns were raised leading up to the vote around administering the vaccine to 16 and 17-year-olds, and some on the panel highlighted the advice of the MHRA in the UK, where the vaccine is currently being rolled out under emergency authorization, that the therapy should not be given to patients with a history of allergic reaction to medicine or food.

With this recommendation, the FDA will now press ahead to review whether to authorise the vaccine for use in the US market. The FDA is not under any obligation to follow the advice of the committee, though it rarely diverts from such recommendations, and the decision will be especially carefully considered in the context of a global pandemic.

The US continues to struggle to reverse the spread of the SARS-CoV-2 virus; so far, more than 293,000 US citizens have died as a result of COVID-19 infection, and the country saw its highest daily death toll from the virus on Wednesday, with over 3,000 deaths recorded – more US deaths in a 24-hour period than in the attack on Pearl Harbor in 1941.

Matt Fellows

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