EC authorizes Pfizer’s PREVENAR 20 vaccine for pediatric Use

In a landmark decision, Pfizer Inc. (NYSE: PFE) has been granted marketing authorization by the European Commission (EC) for its 20-valent pneumococcal conjugate vaccine, PREVENAR 20, aimed at combating invasive pneumococcal disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in infants, children, and adolescents aged between 6 weeks and less than 18 years. This move is poised to significantly bolster public health within the European Union by providing robust protection against 20 serotypes of the pneumococcal disease, marking a substantial leap in pediatric healthcare.

The authorization, applicable across all 27 EU member states plus Iceland, Lichtenstein, and Norway, not only underscores Pfizer’s unwavering dedication to vaccine development but also sets a new standard in pediatric immunization. Alexandre de Germay, Chief International Commercial Officer and Executive Vice President at Pfizer, heralded this achievement as a pivotal moment for public health in the EU, emphasizing the vaccine’s comprehensive serotype coverage. PREVENAR 20’s approval by the EC is an extension of its previous sanction by the U.S. Food and Drug Administration (FDA) in April 2023, alongside its approval in other nations including Canada, Australia, and Brazil, further solidifying its global healthcare impact.

PREVENAR 20 integrates 13 serotypes from its predecessor, PREVENAR 13, with seven additional serotypes identified as significant global contributors to invasive pneumococcal disease (IPD). These serotypes have been linked to severe health outcomes such as high case-fatality rates, antibiotic resistance, and meningitis. The Phase 3 clinical trial program, consisting of four core pediatric studies, has played a critical role in demonstrating the safety, tolerability, and immunogenicity of PREVENAR 20, involving more than 5,500 infants and children.

The EC’s approval of PREVENAR 20 represents a monumental stride in pediatric health, offering a broader spectrum of protection against pneumococcal diseases. By addressing the 20 serotypes responsible for the majority of infections, Pfizer not only enhances global health security but also reinforces its leadership in vaccine innovation. This development could significantly reduce the incidence of invasive pneumococcal diseases among the pediatric population in the EU, marking a critical step forward in preventive healthcare.