21-valent Pneumococcal Conjugate Vaccine Approaches 4th Approval

Merck announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.
Pneumococcal disease is an infection caused by Streptococcus pneumoniae. There are about 100 types of pneumococcal bacteria, and they can affect adults differently than children.
“Invasive pneumococcal disease and pneumococcal pneumonia remain critical public health challenges worldwide,” said Dr. Paula Annunziato, senior vice president of infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories, in a press release on January 31, 2025.
The CHMP’s recommendation for marketing authorization in the European Union (EU), Iceland, Liechtenstein, and Norway will now be reviewed by the European Commission. A final decision is expected by the second quarter of 2025.
If approved in the EU, it would mark the fourth authorization of CAPVAXIVE for preventing invasive pneumococcal disease and pneumococcal pneumonia in adults.
CAPVAXIVE was first approved in the U.S. in June 2024, Canada in July 2024, and Australia in January 2025. It is being reviewed in Japan, and other worldwide regulatory filings are underway.
In the U.S., pneumococcal vaccines are recommended for most people and are available at most community pharmacies. These vaccines may not work for everyone.
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