Vaccine

European Commission Approves Pfizer’s PREVENAR 20® to Help Protect Infants and Children Against Pneumococcal Disease

Published March. 26. 2024

In a landmark decision hailed as a significant stride forward in pediatric immunization, Pfizer Inc. announced today that the European Commission (EC) has granted marketing authorization for their groundbreaking 20-valent pneumococcal conjugate vaccine, now known in the European Union as PREVENAR 20®. This authorization extends to infants, children, and adolescents from 6 weeks to just shy of 18 years old.

“The EC’s authorization of PREVENAR 20 for infants and children represents a significant opportunity to improve public health by helping to protect against the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU,” remarked Alexandre de Germay, Pfizer’s Chief International Commercial Officer and Executive Vice President. “PREVENAR 20 builds on Pfizer’s decades-long commitment to develop vaccines to help prevent potentially life-threatening infections.”

The approval follows a recent positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and is valid in all 27 EU member states, as well as Iceland, Lichtenstein, and Norway. This green light comes on the heels of PREVNAR 20’s approval for infants and children by the U.S. Food and Drug Administration (FDA) in April 2023, marking a significant stride in global pediatric immunization efforts.

The EC authorization was granted based on robust evidence from a comprehensive Phase 3 clinical trial program encompassing four core pediatric studies. These trials collectively enrolled more than 4,700 infants and 800 toddlers and children of all ages, expanding the data on the vaccine’s safety, tolerability, and immunogenicity.

PREVENAR 20 represents a significant advancement over its predecessor, PREVENAR 13, by including seven additional serotypes responsible for invasive pneumococcal disease. These serotypes, now included in the vaccine, are associated with high case-fatality rates, antibiotic resistance, and/or meningitis. Together, the 20 serotypes covered by PREVENAR 20 are responsible for the majority of circulating pneumococcal disease cases in the EU and globally.

In a broader context, this approval underscores Pfizer’s commitment to combating infectious diseases through vaccine innovation. The company’s expansion of the PREVENAR franchise to include coverage for a wider age range, from infants to adults, demonstrates their dedication to public health and disease prevention.

The EC authorization for PREVENAR 20 represents a significant milestone in Pfizer’s efforts to address the global burden of pneumococcal disease, particularly among vulnerable populations. This latest development underscores the importance of ongoing investment in vaccine research and development to protect individuals of all ages from preventable infectious diseases.

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