Pfizer Targeting Late November for Covid Vaccine Application

  • Company could seek emergency-use authorization in U.S.
  • Readout on vaccine developed with BioNTech possible this month

A health worker vaccinates a participant during clinical trials in Florida.

Photographer: Eva Marie Uzcategui/Bloomberg
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Pfizer Inc. said it could seek emergency-use authorization for its Covid-19 vaccine in the U.S. by late November if the shot is shown to be effective in a large late-stage trial, putting to rest any notion that a vaccine could be cleared for emergency use in the U.S. before Election Day.

Safety reviews will dictate the time line, with the U.S. Food and Drug Administration requiring that at least half the people in the study be watched for side effects for two months. That milestone should be achieved in the third week of November, Pfizer Chief Executive Officer Albert Bourla said in an open letter published Friday on the company’s website.