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
Ref: Pfizer | Image: The Wall Street Journal
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