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Moderna To Ask US, European Regulators To Allow Emergency Use Of Its COVID-19 Vaccine

  • December 01, 2020

The AP (11/30, Neergaard) reports, “Moderna Inc. said it would ask U.S. and European regulators Monday to allow emergency use of its COVID-19 vaccine as new study results confirm the shots offer strong protection – ramping up the race to begin limited vaccinations as the coronavirus rampage worsens.” The company “said the shots’ effectiveness and a good safety record so far – with only temporary, flu-like side effects – mean they meet requirements set by the U.S. Food and Drug Administration for emergency use before the final-stage testing is complete. The European Medicines Agency, Europe’s version of FDA, has signaled it also is open to faster ‘conditional’ clearance.”
      The New York Times (11/30, Grady) reports that the company’s “application is based on data that it also announced on Monday, showing that its vaccine is 94.1 percent effective, and that its study of 30,000 people has met the scientific criteria needed to determine whether the vaccine works.” In addition, the new data “showed that the vaccine was 100 percent effective at preventing severe disease from the coronavirus.”