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October 06, 2020

Health Law Daily

White House Blocks New Federal Guidelines For Emergency Release Of Coronavirus Vaccine

  • October 06, 2020

The New York Times (10/5, LaFraniere, Weiland) reports, “Top White House officials are blocking strict new federal guidelines for the emergency release of a coronavirus vaccine, objecting to a provision that would almost certainly guarantee that no vaccine could be authorized before the election on Nov. 3, according to people familiar with the approval process.” Now, the FDA “is seeking other avenues to ensure that vaccines meet the guidelines,” which “includes sharing the standards – perhaps as soon as this week – with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use.”
      The AP (10/5, Miller) reports, “At issue was the FDA’s planned requirement that participants in the ongoing mass clinical trials for nearly a half-dozen vaccine candidates be followed for two months to ensure there are no side effects and that the vaccines provide lasting protection from the virus in order to receive emergency approval.” A senior Administration official “confirmed the move Monday evening, saying the White House believed there was ‘no clinical or medical reason’ to add additional screening protocols.”
      The Hill (10/5, Seipel) also reports on the story.