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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post