Merck Capvaxive gets European Commission nod for prevention of Invasive Pneumococcal Disease, Pneumococcal Pneumonia in adults
European Commission (EC) Approves Merck’s CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults
Rahway: Merck, known as MSD outside of the United States and Canada, has received approval from the European Commission (EC) for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older.
CAPVAXIVE is a pneumococcal vaccine specifically designed to help protect adults from the serotypes responsible for the majority of invasive pneumococcal disease (IPD) cases. The EC approval of CAPVAXIVE is based on safety and immunogenicity data from the Phase 3 STRIDE clinical program.
This decision authorizes the marketing of CAPVAXIVE in all 27 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway. The timing for availability of CAPVAXIVE in individual countries will depend on multiple factors, including the completion of reimbursement procedures. CAPVAXIVE was approved in the U.S. in June 2024, in Canada in July 2024, and in Australia in January 2025.
“Pneumococcal disease continues to pose a significant risk for adults in Europe, among adults who are 65 or older, and also among younger adults who are immunocompromised or have chronic medical conditions,” said Dr. Lina Pérez Breva, Vaccine Research, Fisabio - Public Health, Valencia, Spain. “Based on data from the Phase 3 STRIDE clinical program, CAPVAXIVE offers coverage against the serotypes responsible for the majority of invasive disease cases in adults, making this approval in the EU an important step in helping to protect adults from pneumococcal disease.”
“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. “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.”
European Union country-level data have demonstrated that the serotypes covered by CAPVAXIVE are responsible for more cases of IPD in adults compared to PCV20 (pneumococcal 20-valent conjugate vaccine), as shown in these selected four countries:
Coverage of Serotypes Responsible for IPD in Select EU Countries | ||||
Country | Age | Year Reported | CAPVAXIVE | PCV20 |
Germany | ≥60 | 2020 | ~84% | ~58% |
France | >65 | 2022 | ~85% | ~63% |
Italy | >65 | 2023 | ~77% | ~64% |
Spain | >65 | 2020 | ~82% | ~62% |
Data were included for select countries based on EU membership, population size and the most recent year reported. These values are based on country-level epidemiologic data and regional variations may exist; they do not reflect the efficacy of the respective vaccines. There are currently no studies comparing the efficacy of CAPVAXIVE and PCV20.
The decision by the EC follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use released in January 2025 and was based on 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, and STRIDE-10 (NCT05569954), which compared CAPVAXIVE to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine. The approval is also supported by results from the Phase 3 STRIDE-4 (NCT05464420), STRIDE-5 (NCT05526716), STRIDE-6 (NCT05420961), and STRIDE-7 (NCT05393037) trials (see “Clinical data supporting EC approval” below, for additional details).
