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December 16, 2020

Health Law Daily

FDA Review Concludes Moderna COVID-19 Vaccine “Highly Effective”

  • December 16, 2020

The Washington Post (12/15, Johnson) reports the COVID-19 “vaccine developed by...Moderna appears poised for regulatory clearance after a detailed data review by Food and Drug Administration scientists confirmed the two-shot regimen was ‘highly effective’ in a clinical trial and carried no serious safety concerns.” The agency “is likely to authorize the Moderna vaccine as soon as Friday, according to a person with knowledge of the situation.” Anticipating this decision, Operation Warp Speed chief operating officer Gen. Gustave Perna “said Monday that the United States was preparing to ship almost 6 million doses of the Moderna vaccines to 3,285 locations in the first week.”
      USA Today (12/15, Weintraub) reports the FDA’s Vaccines and Related Biological Products Advisory Committee “will review the data in an all-day meeting Thursday” and if it “decides that the vaccine’s benefits outweigh its risks, the vaccine is likely to be authorized this week by the FDA commissioner.” USA Today adds, “An independent advisory committee to the U.S. Centers for Disease Control and Prevention will review the data this weekend and will vote on whether to add the vaccine to the nation’s vaccine schedule for adults.”
      The New York Times (12/15, A1, Weiland, Grady, Zimmer) reports the FDA review “confirms Moderna’s earlier assessment that its vaccine had an efficacy rate of 94.1 percent in a trial of 30,000 people. Side effects – including fever, headache and fatigue – were common and unpleasant, but not dangerous, the agency found.”