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Pfizer and BioNTech's Comirnaty Receive the US FDA's Approval to Prevent COVID-19 in Individuals Aged 16 Years and Older

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Pfizer and BioNTech's Comirnaty Receive the US FDA's Approval to Prevent COVID-19 in Individuals Aged 16 Years and Older

Shots:

  • The approval is based on the longer-term follow-up data from the P-III trial that showed high efficacy and favorable safety profile through 6mos. after the second dose
  • The vaccine will now be marketed as Comirnaty and is fully approved for the prevention of COVID-19 in individuals aged ≥16 yrs. The companies also plan to license a third or booster dose of Comirnaty in the same age group through sBLA
  • The vaccine continues to be available under a EUA for individuals aged 12-15 yrs. and for the administration of the third dose in immunocompromised patients. The companies plan to submit an sBLA to support full FDA approval of the vaccine in individuals aged 12-15 yrs.

Click here  | Ref: Pfizer | Image: Wall Street Journal

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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