Merck & Co’s – known as MSD outside the US and Canada – adult-specific 21-valent pneumococcal conjugate vaccine has been recommended for approval by the European Medicines Agency’s human medicines committee.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that Capvaxive be used to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals aged 18 years and older.
Diseases caused by Streptococcus pneumoniae bacteria are currently considered a “major public health problem” by the World Health Organization (WHO).
There are more than 100 different types of pneumococcal bacteria and Merck’s Capvaxive, which is administered in a single dose, is specifically designed to help protect against the ones that are responsible for the majority of adult invasive pneumococcal disease, including eight strains not covered by any other approved pneumococcal vaccine.
The CHMP’s recommendation was based on results from the late-stage STRIDE-3 trial, which compared Capvaxive to Pfizer’s 20-valent vaccine (PCV20) in adults who had not previously received a pneumococcal vaccine.
Capvaxive elicited non-inferior immune responses compared to PCV20 for all ten serotypes common to both vaccines in adults aged 50 years and older, and generated superior immune responses for ten of its 11 unique serotypes. Additionally, Merck’s vaccine elicited non-inferior immune responses in adults aged 18 to 49 years compared to those aged 50 to 64 years and had a safety profile comparable to PCV20.
The recommendation was also supported by results from the phase 3 STRIDE-4, STRIDE-5, STRIDE-6, STRIDE-7 and STRIDE-10 trials.
The European Commission (EC) will now review the positive opinion as it makes a final decision on Capvaxive, which is expected by the second quarter of 2025.
Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories, said: “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 hospitalisation, organ damage and even death. We are pleased with the CHMP recommendation and look forward to the EC’s decision.”