image credit: The U.S FDA / Flickr

FDA to set high bar for emergency COVID-19 vaccine approvals

September 23, 2020

The FDA is set to take a tough line on the evidence required to support emergency use authorization (EUA) of COVID-19 vaccines, according to The Washington Post. The reported requirements suggest a company is unlikely to have the data needed to support an EUA before the election in six weeks.

President Donald Trump has repeatedly predicted a vaccine will be ready for the election in the first week of November. The potential political benefits of hitting that target, coupled to events such as the convalescent plasma EUA press conference, have raised concerns that the FDA will come under pressure to authorize a vaccine before the election.

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