Panel to vote on Moderna COVID-19 vaccine


If approved, it would help pave the way for a second COVID-19 vaccine to be distributed across the U.S.

WASHINGTON — A U.S. Food and Drug Administration advisory panel is slated to vote Thursday on whether to recommend the approval of the Moderna coronavirus vaccine for emergency use.

If approved, it would help pave the way for a second COVID-19 vaccine to be distributed across the U.S. The news comes as cases across the country are ramping up, with nearly 17 million confirmed cases since the beginning of the year. There have been more than 307,00 deaths from the coronavirus, according to Johns Hopkins University.

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Last month, Moderna and NIH reported that their shot appeared to be nearly 95% effective across various ages and racial groups, according to results from an ongoing 30,000-person study. The main side effects were fatigue, muscle aches and injection-site pain after the second dose. Those flu-like reactions are common to many vaccines and are a sign the vaccine is revving up the immune system to help fight off the virus.

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Moderna reported no major safety problems from its study. But FDA’s panel is certain to scrutinize the data for any indications of possible severe allergic reactions or other rare side effects.

Officials in the U.K. are investigating several adverse reactions there with Pfizer’s vaccine and FDA is closely monitoring the rollout here for similar reports.

Both Moderna’s and Pfizer-BioNTech’s shots are so-called mRNA vaccines, a brand-new technology. They aren’t made with the coronavirus itself, meaning there’s no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.

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Hospitals across the U.S. this week started ramping up vaccinations with the shot developed by Pfizer and BioNTech’s, the first approved COVID-19 vaccine in the U.S., which the FDA cleared last week.

Packed in dry ice to stay at ultra-frozen temperatures, shipments of Pfizer’s COVID-19 vaccine are set to arrive at 400 additional hospitals and other distribution sites. The first 3 million shots are being strictly rationed to front-line health workers and elder-care patients, with hundreds of millions more shots needed over the coming months to protect most Americans.

Army Gen. Gustave Perna, the chief operating officer for President Trump’s Operation Warp Speed, and other health officials projected that 20 million Americans will be able to get their first shots by the end of December, and 30 million more in January.

The Associated Press contributed to this report.


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