EMA Recommends Approval of Capvaxive Pneumococcal Vaccine

The European Medicines Agency (EMA) has recommended granting marketing authorization for the pneumococcal vaccine Capvaxive (pneumococcal polysaccharide conjugate vaccine [21-valent]) intended to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae in people aged 18 years or older.

There are approximately 100 different serotypes of pneumococcal bacteria, which can affect adults differently than children.

Vaccine Overview

The active substance of Capvaxive works by triggering an immune response against 21 serotypes that cause most invasive pneumococcal disease cases.

At its January meeting, the EMA’s Committee for Medicinal Products for Human Use accepted immunobridging data demonstrating the vaccine’s effectiveness.

Clinical Data and Efficacy

The recommendation was largely based on positive results from a phase 3 randomized, double-blind clinical trial (STRIDE-3), which evaluated the vaccine’s safety, tolerability, and immunogenicity. The study found that Merck’s Capvaxive was noninferior to Pfizer’s Prevenar 20 (pneumococcal polysaccharide conjugate vaccine) for the 10 serotypes common to both vaccines.

Prevenar 20 is already approved for use in the European Union (EU).

Side Effects and Availability

Common side effects of Capvaxive are pain at the injection site, fatigue, headache, and myalgia.

The vaccine is supplied as a solution for injection in a prefilled syringe. 

The EMA’s recommendation will now be sent to the European Commission for final approval. If authorized for EU use, it will mark the fourth approval for Capvaxive in this indication. The vaccine was greenlit in the United States and Canada in 2024 and in Australia earlier this month.

Peter Russell has been a journalist for 40 years covering international news, health, medicine, and national politics on radio, TV, and online. He is based in the United Kingdom.