Administration Updates / Coronavirus / Safety & Health

FDA Working Quickly to Authorize Moderna’s Covid Vaccine

vaccineModerna 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 in a 20-0 vote, with one abstention, Thursday. 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.”

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.

Reprinted with Permission from - Bloomberg Government by John Lauerman and Anna Edney

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