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February 2, 2025 — The European Medicines Agency (EMA) has recommended granting marketing authorization for Capvaxive, a 21-valent pneumococcal polysaccharide conjugate vaccine. The vaccine is designed to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals aged 18 years and older.
Vaccine Overview
Capvaxive works by triggering an immune response against 21 serotypes responsible for most cases of invasive pneumococcal disease. Given the approximately 100 different serotypes of pneumococcal bacteria, the vaccine aims to offer broad protection, particularly in adults, who may be affected differently than children.
Clinical Data and Efficacy
The EMA’s Committee for Medicinal Products for Human Use (CHMP) accepted immunobridging data at its January meeting, supporting the vaccine’s effectiveness. The recommendation is primarily based on results from the STRIDE-3 phase 3 clinical trial, a randomized, double-blind study evaluating the safety, tolerability, and immunogenicity of Capvaxive. The trial demonstrated that the vaccine was noninferior to Pfizer’s Prevenar 20, which is already approved in the European Union, for the 10 serotypes common to both vaccines.
Side Effects and Availability
The most commonly reported side effects of Capvaxive include pain at the injection site, fatigue, headache, and myalgia. The vaccine is provided as a solution for injection in a prefilled syringe.
Following the EMA’s recommendation, the decision now moves to the European Commission for final approval. If authorized, this will be the fourth approval for Capvaxive in this indication, following its 2024 approvals in the United States and Canada and its more recent approval in Australia earlier this month.
Disclaimer
This article is intended for informational purposes only and should not be construed as medical advice. Individuals should consult healthcare professionals for guidance on vaccinations and medical treatments.
