FDA Speeds Toward Moderna Vaccine Authorization as Soon as Today
Signage is displayed on the Moderna Inc. headquarters in Cambridge, Massachusetts, U.S. (Photographer: Adam Glanzman/Bloomberg)

FDA Speeds Toward Moderna Vaccine Authorization as Soon as Today

Moderna Inc.’s Covid-19 vaccine is expected to gain clearance from the Food and Drug Administration as soon as Friday, as the regulator indicated it is working to make the shot available as soon as possible.

FDA Commissioner Stephen Hahn said that the agency will work quickly toward authorizing the vaccine, which a panel of outside advisers backed Thursday in a 20-0 vote, with one abstention. A similar shot from Pfizer Inc. and BioNTech was cleared for use in the U.S. last week.

“The American people can be confident. We have one, and perhaps within hours two, safe and effective coronavirus vaccines for you and your family,” Vice President Mike Pence said on Friday. Pence received the Pfizer vaccine in a televised event Friday to encourage Americans to get immunized.

Anthony Fauci, the top U.S. infectious disease expert, said on NBC’s “Today” show that he expected Moderna’s vaccine would begin to be administered “by the very early part of next week. I would hope Monday or Tuesday.” Fauci said he aims to get vaccinated in the next few days. Most Americans will be able to get vaccinated by around March, he said.

Earlier, President Donald Trump tweeted that the vaccine was “overwhelmingly approved” and that distribution of it would “start immediately.” However, the shot hasn’t yet been granted an emergency authorization, an FDA spokesperson said.

The FDA 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 expected to play an important role in the government’s plans for mass immunization and slowing the pandemic. 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.

©2020 Bloomberg L.P.

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