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From: scion	12/15/2020 8:17:53 AM
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Moderna Vaccine Found Safe, Effective Ahead of Key FDA Review By Anna Edney December 15, 2020, 1:07 PM GMT bloomberg.com Shot is 94.1% effective in preventing Covid, FDA report says Advisory committee to weigh shot’s merits ahead of clearance Moderna Inc.’s vaccine is safe and effective for preventing Covid-19, U.S. regulators said, clearing the way for a second shot to quickly gain emergency authorization and add to the country’s sprawling immunization effort. The Food and Drug Administration’s staff said in a report on Tuesday that the experimental vaccine is 94.1% effective at preventing symptomatic Covid-19, confirming earlier results released by the company. The report was posted online ahead of a meeting Thursday of agency advisers who will vote whether to recommend authorization before a final FDA decision. The agency doesn’t have to follow the advice of the independent vaccine experts, though it often agrees with its advisory panels. Last week, the FDA authorized a similar vaccine from Pfizer Inc. and BioNTech SE after an advisory panel voted 17-4, with one abstention, to support its authorization. The FDA got a much deeper look at Moderna’s clinical-trial data than the numbers previously released to the public by the company. Notably, the agency was able to review the shot’s effectiveness across a broad range of racial, ethnic and age groups, and look at evidence of how well the shot worked for people with pre-existing medical conditions that make them more vulnerable to severe Covid-19. ... MORE bloomberg.com

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