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

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

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  • 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

 ­ Ref: Businesswire | Image: Financial Times

Click here to­ read the full press release 

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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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