EC Approves Merck's Capvaxive Pneumococcal Vaccine for Adults

Merck & Co, known internationally as MSD, has successfully obtained approval from the European Commission (EC) for its innovative 21-valent pneumococcal conjugate vaccine, Capvaxive. This development marks a significant advancement in the prevention of invasive pneumococcal disease and pneumonia in adults, specifically targeting those aged 18 and older. Capvaxive, designed meticulously to address the prevalent strains of Streptococcus pneumoniae, is administered in a single dose, offering comprehensive protection against the bacteria responsible for most adult invasive pneumococcal diseases.

Pneumococcal diseases, including pneumonia, sepsis, and meningitis, represent a substantial global health challenge, contributing to high mortality rates annually. With over 100 known types of pneumococcal bacteria, Merck's Capvaxive is tailored to combat the strains most frequently connected to adult infections, promising enhanced health security for this demographic.

The EC's endorsement is a result of positive recommendations from the European Medicines Agency’s human medicines committee. The approval was heavily supported by compelling data from the phase 3 STRIDE-3 trial, which meticulously assessed the efficacy of Capvaxive against Pfizer’s 20-valent vaccine (PCV20) in adults who had not previously received a pneumococcal vaccine. The trial revealed that Capvaxive successfully induced comparable immune responses to PCV20 across all ten serotypes shared by both vaccines in adults aged 50 and above. Furthermore, Capvaxive demonstrated superior immune responses for ten of the 11 unique serotypes it targets.

For younger adults aged 18 to 49, Capvaxive elicited immune responses that were non-inferior to those observed in the 50 to 64 age group, establishing its efficacy across a broad age range. This impressive safety profile was found to be on par with that of the PCV20 vaccine. Additional supporting evidence from phase 3 trials STRIDE-4, STRIDE-5, STRIDE-6, STRIDE-7, and STRIDE-10 further bolstered the decision by the European regulatory authorities.

Paula Annunziato, who serves as the senior vice president of infectious diseases and vaccines in global clinical development at Merck Research Laboratories, emphasized the importance of targeting specific serotypes responsible for the increasing cases of adult invasive pneumococcal disease. She stated, “Capvaxive enables us to offer protection specifically designed for adults, which we are proud to bring to Europe. We are committed to working with regulatory bodies to ensure Capvaxive's global availability.”

This European approval follows Capvaxive’s successful authorization by the US Food and Drug Administration in June of the previous year. The vaccine has also been approved in Canada and Australia, signaling a growing recognition of its potential to significantly impact public health efforts worldwide. As Merck continues to collaborate with regulatory authorities, Capvaxive is poised to play a crucial role in combating pneumococcal diseases, offering hope and enhanced protection to adults across various regions.