Merck, known as MSD outside the US and Canada, has received the European Commission (EC) approval for Capvaxive, a 21-valent pneumococcal conjugate vaccine.
Capvaxive is designed for active immunisation, as a single dose, against invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals aged 18 and older.
The vaccine targets Streptococcus pneumoniae serotypes, including eight unique serotypes that are primarily responsible for adult invasive pneumococcal disease (IPD).
Its approval indicates a significant step in expanding the vaccine’s reach across Europe.
Capvaxive is already approved by the US Food and Drug Administration (FDA) for a similar indication.
With the EC approval, Capvaxive can market the vaccine in all 27 European Union (EU) member states, along with Iceland, Liechtenstein, and Norway.
Merck Research Laboratories Global Clinical Development infectious diseases and vaccines senior vice president Paula Annunziato said: “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.
“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.”
The EC approval of Capvaxive follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation, granted in January 2025.
The decision was based on safety and immunogenicity data from the Phase 3 STRIDE clinical programme, which included the STRIDE-3 and STRIDE-10 trials.
In the STRIDE-3 trial, Capvaxive was evaluated against PCV20 (pneumococcal 20-valent conjugate vaccine) in adults who had not previously received a pneumococcal vaccine.
STRIDE-10 compared Capvaxive to PPSV23 (pneumococcal 23-valent conjugate vaccine) in adults aged 50 and older without prior pneumococcal vaccination.
In addition, results from the Phase 3 STRIDE-4, STRIDE-5, STRIDE-6, and STRIDE-7 trials also supported the approval.
Fisabio – Public Health vaccine researcher Lina Pérez Breva said: “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.
“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.”
