FDA could issue emergency use authorization for coronavirus vaccine in a matter of weeks

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FDA could issue emergency use authorization for coronavirus vaccine in a matter of weeks

The US Food and Drug Administration could issue emergency use authorization (EUA) of a coronavirus vaccine in a matter of weeks, once a vaccine meets efficacy requirements, Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research, which approves vaccines, said Wednesday.

“We stand ready for using emergency use authorization in an appropriate setting,” Marks said during an online event called the Disease Control and Prevention Summit.

An EUA would green light a coronavirus vaccine for use on an expedited basis.

Marks said the increased attention the agency is giving to coronavirus vaccine trials should speed up the process of granting emergency use authorization to a vaccine that crosses an efficacy boundary in a clinical trial.

“We’d like to hope that when that happens, it will be a matter of weeks before we could actually potentially have something like an emergency use authorization,” said Marks, who added that he hopes the EUA will apply to a relatively broad population. “Emergency use authorization will be for the population for which we have appropriate data.”

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

“The first vaccines that come along may be slightly disadvantaged compared to ones that come along later,” said Marks, who suspects the “trailblazer” vaccines will reveal information that can speed up the process for subsequent vaccine candidates.

Some context: Two potential vaccines started advanced trials this week in the US.

“There are aspirational timelines, and I think that’s actually wonderful here, that people have aspirations for moving forward as quickly as possible, but we all know that real life generally does not go as well as our aspirations,” Marks said.

Source: CNN | News Colony

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