FDA says it will 'rapidly work toward' authorizing Moderna's COVID-19 vaccine

FDA says it will 'rapidly work toward' authorizing Moderna's COVID-19 vaccine
Moderna; Samantha Lee/Business Insider
  • The US Food and Drug Administration announced Thursday that it "will rapidly work toward finalization and issuance of an emergency use authorization" of Moderna's COVID-19 vaccine.
  • "The agency has also notified the US Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution," FDA Commissioner Dr. Steven Hahn said.
  • The announcement comes after an FDA expert panel earlier on Thursday recommended that the vaccine be approved.

The US Food and Drug Administration announced Thursday that it "will rapidly work toward finalization and issuance of an emergency use authorization" of Moderna's COVID-19 vaccine.

The news comes after an FDA expert advisory panel earlier in the day recommended that the vaccine be approved. In a statement, FDA Commissioner Stephen Hahn said the agency "also notified the US Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution."
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Identical language was used earlier this month before the FDA approved the use of Pfizer's COVID-19 vaccine, which is now being distributed.

Having two authorized vaccines should allow tens of millions of Americans to get vaccinated in the coming months. Operation Warp Speed officials anticipate 20 million Americans will get a shot in December, 30 million more in January, and 50 million more in February.

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Healthcare workers and people living in nursing homes are being vaccinated first. Plans vary by state, but essential workers such as teachers and firefighters are generally next in line. Top government scientists, including Dr. Anthony Fauci and Warp Speed chief advisor Moncef Slaoui, have said vaccines should be available to the general public in late-spring or early summer.

Like Pfizer's vaccine, Moderna's injection excels at preventing COVID-19. A late-stage clinical trial of the shot enrolled more than 30,000 volunteers and determined that Moderna's shot was safe and 94% effective at preventing symptomatic disease. A key advantage of Moderna's shot is that it's easier to ship and store. Unlike Pfizer and BioNTech's vaccine that needs to be stored at negative 94 degrees Fahrenheit, Moderna's is stable for a month with typical refrigeration.
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