FDA Says It Told Vaccine Makers of Principles for Emergency Use

The Food and Drug Administration said it’s made clear to drugmakers the standards for a vaccine to be cleared for emergency use, obviating a more formal FDA guidance document that is still under review by the White House.

As final-stage trials of Covid-19 vaccines proceed, the FDA has worked to make clear what standards would have to be met to authorize use of the shots. One such path is an emergency-use authorization, or EUA, a fast-track procedure that relies on less safety and efficacy data than a full approval.