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FDA could issue emergency use permit for coronavirus vaccine within weeks



The US Food and Drug Administration could issue an Emergency Use Authorization (EUA) for a coronavirus vaccine within a few weeks when the vaccine meets efficacy requirements, Dr. Peter Marks, director of the FDA’s Center for Biological Substances Evaluation and Research, which approves vaccines, said Wednesday.

“We are ready to use the authorization for emergency use in an appropriate environment,” Marks said during an online event called the Summit on Disease Control and Prevention.

The EUA would illuminate the coronavirus vaccine in green, which would be used on an accelerated basis.

Marks said the Agency’s increased attention to attempts at coronavirus vaccination should speed up the process of granting an emergency use authorization for a vaccine that exceeds the efficacy limits in a clinical trial.

“We would like to hope that when this happens, it will take weeks to have something really like an emergency use permit,” said Marks, who added that he hoped the EUA would cover a relatively large population. , “The emergency use permit will be for the population for which we have the relevant data.”

Mark stressed that safety would not be sacrificed in the vaccine plant.

“The first vaccines to come may be slightly at a disadvantage compared to the vaccines that come later,” said Marks, who suspects that trailblazer vaccines will reveal information that could speed up the process of subsequent vaccine candidates.

Some connections: Two potential vaccines began advanced trials in the United States this week.

“There are aspiration schedules, and I think it’s really amazing that people have a desire to move forward as quickly as possible, but we all know that real life in general isn’t going as well as our desires,” Marks said.


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