Pfizer - BioNTech COVID-19 Vaccine Granted Priority Review By FDA

by Vandana Singh, Benzinga Editor
July 16, 2021 1:59 PM | 1 min read |
  • The FDA has granted priority review designation for Pfizer Inc PFE - BioNTech SE's BNTX full approval application of their partnered COVID-19 vaccine, putting it on track for potential full approval by early next year.
  • The goal date for a decision is January 2022.
  • The typical priority review process allows six months, but FDA approval could come before the goal date.
  • The companies said they would apply for full approval in people age 12 to 15 once the required six months of data following second vaccine doses are available.
  • Price Action: PFE shares are +0.50% at $40.29, and BNTX stock is +4.72% at $231.53 during the market session on the last check Friday.
  • Related content: Benzinga's Full FDA Calendar
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsCOVID-19 Vaccine
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