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Outside Experts Endorse Moderna Vaccine

FDA is on track to approve emergency use on Friday, with distribution starting in days
By Bob Cronin,  Newser Staff
Posted Dec 17, 2020 7:10 PM CST

(Newser) – The Food and Drug Administration plans to approve a second coronavirus vaccine for emergency use on Friday, after an outside panel of experts agreed that the benefits of Moderna's product outweigh the risks. The head of the federal vaccine distribution effort plans to ship nearly 6 million doses to 3,285 places in the first week, the Washington Post reports, much the way the first vaccine is being distributed. "It will be a very similar cadence that was executed this week with Pfizer, where we’re hitting initial sites on Monday, [followed] on Tuesday and Wednesday," Gen. Gustave Perna said. Panel members approved the vaccine 20-0 for people over age 18, with one abstention. Unlike the Pfizer vaccine, this one can be stored in normal freezers, making it easier to deliver to small and remote places, per CNN. For places such as rural Texas, where hospitals are overwhelmed, this comes just in time. "They are absolutely at the end of their rope," an industry official said, per KPRC.

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Moderna reports the vaccine is 94% effective, and FDA scientists confirmed that this week. The 30,000 people involved in the trial received two shots either of vaccine or saline, 196 of whom came down with the coronavirus. All but 11 of those had gotten the placebo, and the 30 severe cases and one death all occurred in the placebo group. There were no allergic reactions, a topic that surfaced anyway at the meeting Thursday. After a couple of instances among people given the Pfizer shot, the FDA said no adjustments are needed in its policies. But it's working with both manufacturers to emphasize the requirement that treatment for a severe allergic reaction be available immediately to anyone given the shots. The allergic reactions "underscore the need to remain vigilant during the early phase of the vaccination campaign," an FDA expert said. (Read more Moderna stories.)

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