Gottlieb: Staged Access To Coronavirus Vaccine Possible Through EUA
Former FDA Commissioner says agency could grant an EUA for a vaccine, but require it meet the standard for full approval, and then roll it out gradually with postmarket data collection.
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CBER director said that all the manufacturing data may not be available, but the safety and efficacy data needed for a BLA are expected before an emergency use authorization is granted.
The move reduces the pressure on the companies to rush development, but also relieves burden on the FDA to approve a candidate too soon.