RAHWAY, N.J.– Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the European Commission (EC) has granted approval for CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia in adults aged 18 and older. The vaccine is designed to protect against 21 serotypes of Streptococcus pneumoniae, the bacteria responsible for the majority of IPD cases.
This approval marks a significant milestone for Merck, as CAPVAXIVE becomes the fourth pneumococcal vaccine approved for use in adults. The European Commission’s decision is based on robust data from Merck’s Phase 3 STRIDE clinical program, which demonstrated CAPVAXIVE’s safety and efficacy in preventing infections caused by the targeted serotypes, including those responsible for a rising number of adult pneumococcal disease cases.
The approval authorizes the marketing of CAPVAXIVE in all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway. Availability across these regions will depend on the completion of reimbursement procedures in individual countries.
“The approval of CAPVAXIVE in the EU is a crucial step in addressing the ongoing threat of pneumococcal disease, particularly among adults aged 65 and older, as well as those with weakened immune systems or chronic medical conditions,” said Dr. Lina Pérez Breva, Vaccine Research, Fisabio – Public Health, Valencia, Spain. “With its coverage of the serotypes responsible for the majority of invasive disease cases in adults, CAPVAXIVE represents an important advancement in pneumococcal disease prevention.”
Dr. Paula Annunziato, Senior Vice President of Global Clinical Development for Infectious Diseases and Vaccines at Merck, highlighted the vaccine’s tailored approach to adult protection. “CAPVAXIVE provides coverage against the serotypes that have been responsible for an increasing proportion of adult pneumococcal disease cases. We are excited to bring this broad protection to Europe’s adult population and look forward to expanding its availability worldwide,” she said.
CAPVAXIVE has already been approved for use in the United States (June 2024), Canada (July 2024), and Australia (January 2025), further cementing its role in the global fight against pneumococcal disease.
Merck continues to work with regulatory authorities to ensure that CAPVAXIVE reaches adults worldwide who stand to benefit from its protective coverage against invasive pneumococcal disease and pneumococcal pneumonia.
