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FDA to Demand 2 Months Safety Data, Expert Review for Vaccine

By: - October 6, 2020

The U.S. Food and Drug Administration plans to have an expert panel review any COVID-19 vaccine application for emergency use, along with at least two months of safety data, according to a document posted by the agency Tuesday.

The document is the agency’s most detailed public statement yet on what it will take to get a vaccine cleared under a fast-track emergency use authorization, or EUA. The agency has been working on a separate “guidance” document that details the requirements, but it remains under review by the White House and it’s not clear when or if it will be released.

While the exact contents of that guidance document haven’t been released, the FDA has said that it’s already communicated the requirements to drugmakers. Publishing those requirements in the document released Tuesday essentially makes them public, even if the official document is lodged at the White House.

It also makes clear that the FDA will add an extra step to the review. In Tuesday’s document, the FDA said it will require an additional, follow-up meeting of its Vaccine and Related Biological Products Advisory Committee to look at specific applications by drugmakers.

“This discussion will be specific to the particular vaccine that is the subject of the EUA request and will be separate from, and in addition to, any general discussion by the VRBPAC regarding the development, authorization and/or licensure of vaccines to prevent COVID-19,” the FDA said in the document.

The documents were posted ahead of an Oct. 22 meeting by the VRBPAC to discuss generally how the agency will review a COVID-19 vaccine.


© Copyright 2020 Bloomberg News. All rights reserved.

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