Pfizer and BioNTech’s BNT162b2 Receives the US FDA’s EUA to Prevent COVID-19

December 14, 2020 Auto Bot BioNTech, BLA, BNT162b2, EUA, Pfizer, Prevent, receives, regulatory, Us FDA 0

Shots:

  • Pfizer & BioNTech received the US FDA’s EUA for BNT162b2 for patients aged ≥16yrs with COVID-19. The companies are gathering additional data & prepared to file a planned BLA with the US FDA anticipating full approval in 2021
  • The EUA is based on P-III pivotal study demonstrating 95% efficacy in participants without prior SARS-CoV-2 infection & also in participants with/ out prior infection
  • In Jul 2020, the companies collaborated with the HHS & DoD to meet the Operation Warp Speed program goal to deliver doses of a vaccine for COVID-19

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Financial Times

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