Pfizer's Prevenar 20 Approved for Child Pneumococcal Protection

Photo:Representative Image

Pfizer Inc. has announced that the European Commission (EC) has granted marketing authorization for Prevenar 20, the company's 20-valent pneumococcal conjugate vaccine, for active immunization in infants, children, and adolescents from 6 weeks to under 18. 

This vaccine is marketed in the European Union to prevent invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae.

This authorization represents a significant opportunity to improve public health by helping to protect against the 22 stereotypes responsible for the majority of currently circulating pneumococcal diseases in the EU.

Alexandre de Germay, the Chief International Commercial Officer and Executive Vice President at Pfizer said, "Prevenar 20 builds on Pfizer's decades-long commitment to developing vaccines to help prevent potentially life-threatening infections, and we are proud to provide the broadest serotype coverage of any pneumococcal conjugate vaccine for children in Europe."

This authorization follows the recent positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). It is valid in all 27 EU member states, Iceland, Lichtenstein, and Norway.

Prevnar 20 was also approved for infants and children by the US Food and Drug Administration (FDA) in April 2023 and several other countries, including Canada, Australia, and Brazil. Regulatory applications for PREVENAR 20 for pediatric indication have been submitted to additional countries worldwide

The EC authorization of Prevenar 20 is based on evidence from the phase 3 clinical trial program that comprised four core pediatric studies. These studies collectively enrolled more than 4,700 infants, 800 toddlers, and children of all ages. The studies helped expand the data on the vaccine's safety, tolerability, and immunogenicity.