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FDA Setting Higher Bar for Emergency Covid Vaccine Clearance

  • More rigorous efficacy standard to be used, top official says
  • Agency plans additional monitoring once shot reaches market
Residents Participate In Pfizer Covid-19 Vaccine Clinic Trial
Photographer: Eva Marie Uzcategui/Bloomberg
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Drugmakers seeking an emergency authorization for a Covid-19 vaccine will have to meet a higher standard of efficacy than normally would be required for such a clearance, the head of the U.S. Food and Drug Administration’s office that handles vaccines said.

Typically, an emergency use authorization, or EUA, would require a company to show their product may be effective. Peter Marks, director of the FDA’s biologics office, said Thursday that the agency will require more robust data about how well a coronavirus vaccine works before granting an emergency waiver -- something he called “EUA plus.”