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