FDA May Issue Emergency Use Clearance For Coronavirus Vaccine In Weeks


The United States Food and Drug Administration could issue an Emergency Use Authorization (EUA) for a coronavirus vaccine within weeks, once a vaccine meets efficacy requirements, Dr Peter Marks, director of the FDA Center for Biologics Evaluation and Research, which approves the vaccines, said Wednesday.

“We are prepared to use emergency use authorization in an appropriate setting,” Marks said at an online event called the Disease Control and Prevention Summit.

An EUA would give the green light to a coronavirus vaccine for accelerated use.

Marks said the agency’s increased focus on coronavirus vaccine trials should speed up the process of granting emergency use authorization for a vaccine that crosses an efficacy limit in a trial clinical.

“We would like to hope that when that does happen it will only be a matter of weeks before we can potentially have something like an emergency use authorization,” said Marks, who added that he hopes that the EUA will apply to a relatively large population. . “Emergency use authorization will be for the population for which we have appropriate data. “

Marks stressed that safety will not be sacrificed in the race for the vaccine.

“The first vaccines that arrive may be at a slight disadvantage compared to those that come later,” said Marks, who suspects that “pioneer” vaccines will reveal information that can speed up the process for subsequent vaccine candidates.

A little background: Two potential vaccines began advanced trials this week in the United States.

“There are ambitious timelines, and I think it’s really wonderful here, that people aspire to move forward as quickly as possible, but we all know real life usually doesn’t go as well as our aspirations, ”Marks said.


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