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

August 24, 2021 Auto Bot approval, Comirnaty, Covid-19 Vaccine, FDA, Pfizer/BioNTech, regulatory 0

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 to­ read full press release/ article | Ref: Pfizer | Image: Wall Street Journal

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