Conditional Marketing Authorisation (CMA) for Pfizer and BioNTech’s Comirnaty has been expanded to included individuals 12 to 15 years of age in the EU.
This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group.
The extended indication for the CMA for Comirnaty is valid in all 27 EU member states.
Comirnaty was the first COVID-19 vaccine to receive authorisation in the EU and is the first to have its CMA extended to adolescents.
Distribution and administration by the EU member states will continue to be determined according to the populations identified in the EU and per national guidance.
“Today’s extension of our COVID-19 vaccine authorisation in the European Union is another critical milestone in our collective effort to broaden vaccination programs to as many people as possible,” said Ugur Sahin, CEO and co-founder of BioNTech.
“Making vaccines available to adolescents will help re-open schools, and support the return to a normal day-to-day life.”
The EU decision is based on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years.