Biopharmaceutical company Pfizer Inc (NYSE: PFE) announced on Wednesday that it has secured marketing authorisation from the European Commission (EC) for PREVENAR 20, its 20-valent pneumococcal conjugate vaccine.

The approval spans all 27 EU member states, including Iceland, Lichtenstein and Norway, and follows positive feedback from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

PREVENAR 20 provides broad serotype coverage against 20 strains responsible for the majority of prevailing pneumococcal diseases in the EU and globally. The vaccine is intended for active immunization in infants, children and adolescents aged 6 weeks to less than 18 years, guarding against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae.

This EC approval aligns with previous endorsements from the U.S. Food and Drug Administration (FDA) in April 2023, as well as regulatory nods in Canada, Australia, Brazil and other countries. Regulatory applications for PREVENAR 20's pediatric use have been submitted worldwide.

The authorization is rooted in evidence from a comprehensive Phase 3 clinical trial program, encompassing four core paediatric studies (NCT04546425, NCT04382326, NCT04379713, NCT04642079). These studies, involving over 4,700 infants and 800 toddlers and children, have contributed to expanding data on the vaccine's safety, tolerability and immunogenicity.