Merck's CAPVAXIVE Gets Positive EU CHMP Opinion For Pneumococcal Vaccination In Adults

(RTTNews) - Drug major Merck & Co. (MRK) announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP recommended the approval of CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for Pneumococcal Vaccination in adults.

The CHMP's recommendation is for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.

The recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein and Norway. A final decision is expected by the second quarter of 2025.

Pneumococcal disease, an infection caused by a bacteria called Streptococcus pneumoniae, affect adults differently than children, and there are about 100 different types or serotypes of the bacteria.

CAPVAXIVE is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease or IPD cases.

The company noted that the clinical data supporting the recommendation include results from the pivotal Phase 3 STRIDE-3 trial (NCT05425732), which evaluated CAPVAXIVE compared to PCV20 in adults 18 years of age and older who had not previously received a pneumococcal vaccine.

The recommendation is also supported by results from the Phase 3 STRIDE-4 (NCT05464420), STRIDE-5 (NCT05526716), STRIDE-6 (NCT05420961), STRIDE-7 (NCT05393037) and STRIDE-10 (NCT05569954) trials, evaluating CAPVAXIVE in vaccine-naïve and vaccine-experienced adults.

If approved in the EU, it would mark the fourth authorization of CAPVAXIVE for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults.

CAPVAXIVE was first approved in the U.S. in June 2024, followed by Canada in July 2024, and Australia in January 2025. In addition, CAPVAXIVE is currently under review in Japan, and other worldwide regulatory filings are underway.

Paula Annunziato, senior vice president, infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories, said, "Invasive pneumococcal disease can lead to serious consequences including hospitalization, organ damage and even death. We are pleased with the CHMP recommendation and look forward to the European Commission's decision."

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