Pfizer and BioNTech Receive EC’s Conditional Marketing Approval for the COVID-19 Vaccine in Adolescents

May 31, 2021 Auto Bot Adolescents, BioNTech, Comirnaty, Covid-19 Vaccine, Pfizer, regulatory 0

Shots:

  • The approval is based on a P-III study assessing Comirnaty (two 30μg doses) in 2,260 participants aged 12-15yrs. and showed 100% efficacy in participants with/out prior SARS-CoV-2 infection, robust Ab responses and was well tolerated
  • The approval follows CHMP’s positive opinion to authorize the vaccine in this group. The extended indication for the CMA for Comirnaty is valid in all 27 EU member states
  • Comirnaty is the first COVID-19 vaccine to receive approval in the EU and is the first to have its CMA extended to adolescents. The company will continue to monitor the vaccine for long-term protection & safety for an additional 2yrs. after the second dose

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

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