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November 23, 2020

Health Law Daily

Pfizer, BioNTech Seek Emergency Use Authorization From US FDA For Their SARS-CoV-2 Vaccine

  • November 23, 2020

The AP (11/20, Neergaard) reported Pfizer and BioNTech are seeking an emergency use authorization (EUA) from the US FDA for their SARS-CoV-2 vaccine. The two companies recently announced that their “vaccine appears 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study.”
      CNN (11/20, Gumbrecht) reports, “The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee, a group of outside experts, for December 8, 9 and 10, a source familiar with the process told CNN this week.” The FDA could decide “at the end of the meeting on December 10 about whether to issue an emergency use authorization, the source said.”
      STAT (11/20, Branswell) also covered the story.