The Food and Drug Administration published guidance Tuesday detailing what’s required for the emergency authorization of a coronavirus vaccine after the advice to pharmaceutical companies was delayed by White House review.
Drugmakers must provide data showing they followed clinical trial participants for a median of two months after their final vaccine injection, according to guidelines posted on the FDA’s website. The agency also wants companies to submit vaccines for authorization only after at least five severe cases of COVID-19 have been seen in volunteers who got the placebo, according to the guidance.
The requirements laid out in the guidance underscore why it’s unlikely a vaccine could clear the agency before Election Day.
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