FDA to Issue Stricter Guidance for Emergency Authorization of COVID-19 Vaccine

The new guidance is being reviewed by the White House Office of Management and Budget, and elements of it have already been shared with the vaccine makers. As per the guidance, the FDA could ask vaccine manufacturers seeking an emergency authorization to follow participants in late-stage clinical trials for a median of at least two months, beginning after they have been administered a second vaccine shot, according to The Washington Post report.

In order to ensure that the COVID-19 vaccine works, the FDA may look for a minimum of five severe cases of COVID-19 in the placebo groups of all the trials, as well as some cases in older people. These tougher standards, coupled with the time required for the vaccine makers to prepare their applications as well as for the FDA to review the data, make it highly unlikely for any COVID-19 vaccine to be authorized before the US presidential election.

“It’s hard to imagine how an (emergency use authorization) could possibly occur before December,” Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s advisory board on vaccines, told The Washington Post.

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US Food and Drug Administration (FDA)