Moderna Authorization Bid to Get Quick FDA Attention, Hahn Says

The U.S. Food and Drug Administration will work quickly toward authorizingModerna Inc.’s Covid-19 vaccine that agency advisers voted Thursday to recommend, Commissioner Stephen Hahn said.

The regulator told Moderna “that it will rapidly work toward finalization and issuance of an emergency use authorization,” Hahn said late Thursday in a statement. “The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.”

Moderna’s vaccine is counted on for an important role in the government’s plans for mass immunization and slowing the pandemic that has stifled economies worldwide. The regulator last week authorized a vaccine fromPfizer Inc. andBioNTech SE for emergency use and its advisers voted 20 to 0, with one abstention, in favor of granting the samestatus to Moderna’s.

The government is moving quickly to distribute Covid-19 vaccines, which began rolling out Monday. Between Pfizer and Moderna, up to 20 million people in the U.S. are expected to get their first shots by year-end.

In their Thursday meeting, the advisers discussed issues including rare, but serious, allergic side effects that have been seen in some people who have received the Pfizer vaccine. While the FDA doesn’t always follow the recommendations of its advisers, it often does.

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