Europe Approves Pneumococcal 21-valent Conjugate Vaccine

With about 100 different types of pneumococcal bacteria infecting people, innovative vaccines are needed to reduce various illnesses, including pneumonia, meningitis, and bloodstream infections.

For example, in Europe, 17,700 confirmed invasive pneumococcal disease (IPD) cases were reported in the European Union/European Economic Area in 2022.

To address this disease, Merck announced today that the European Commission (EC) has approved CAPVAXIVE® (V116), designed to help protect adults against IPD and pneumococcal pneumonia.

CAPVAXIVE targets the serotypes causing most IPD cases in adults and includes eight unique serotypes not covered by other approved vaccines.

This EC decision authorizes the approval of CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) in all 27 European Union (EU) member states, including Iceland, Liechtenstein, and Norway.

“By focusing on the serotypes that have been responsible for an increasing proportion of adult invasive pneumococcal disease cases, CAPVAXIVE allows us to offer protection specifically designed for adults,” said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories, in a press release on March 26, 2025.

“We are proud to bring CAPVAXIVE to adults in Europe who may benefit from its broad protection and are eager to continue working with regulatory authorities to expand CAPVAXIVE availability worldwide.”

The EC approval is based on safety and immunogenicity data from the Phase 3 STRIDE clinical program.

As of late March 2025, various pneumococcal vaccines are offered in the United States at clinics and pharmacies.

Note: This VBT news article was updated for trademark on March 27, 2025.