Pfizer and BioNTech Receive EC’s Conditional Marketing Approval for the COVID-19 Vaccine in Adolescents
Pfizer’s Ticovac Receives the US FDA’s Approval for the Prevention of Tick-Borne Encephalitis
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