Positive CHMP opinion for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for pneumococcal vaccination in adults – Merck

Merck Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the 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. The CHMP’s recommendation will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU), Iceland, Liechtenstein and Norway, and a final decision is expected by the second quarter of 2025.

“Invasive pneumococcal disease and pneumococcal pneumonia remain critical public health challenges worldwide,” said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories. “This positive opinion is yet another testament to the clinical profile of Capvaxive and brings us a step closer to helping protect adults in the EU against pneumococcal disease. 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.”

Among the clinical data supporting the recommendation are results from the pivotal Phase III 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 III STRIDE-4 (NCT05464420), STRIDE-5 (NCT05526716), STRIDE-6 (NCT05420961), STRIDE-7 (NCT05393037) and STRIDE-10 (NCT05569954) trials, evaluating Capvaxivein vaccine-naïve and vaccine-experienced adults.