MSD has received approval from the European Commission (EC) for Capvaxive, a pneumococcal 21-valent conjugate vaccine, to prevent invasive disease and pneumonia due to Streptococcus pneumoniae serotypes in people aged 18 years and over.
The approval of Capvaxive, indicated for active immunisation, marks a step forward in protection from serotypes most commonly associated with invasive pneumococcal disease (IPD).
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The EC’s decision allows for the marketing of the vaccine across all 27 European Union member states, along with Liechtenstein, Norway and Iceland.
The vaccine’s availability in individual nations will be subject to various factors, including reimbursement procedure completion.
In June and July 2024, the vaccine gained approval in the US and Canada. It was approved in Australia in January 2025.
The EC’s decision was influenced by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use’s positive recommendation in January 2025.
Capvaxive’s approval was supported by the data, which includes Phase III clinical trials to assess its immunogenicity and safety in adults.
The pivotal Phase III STRIDE-3 trial was one of the key studies, comparing the vaccine against PCV20 in adults who had not previously received a pneumococcal vaccine.
The STRIDE-10 trial compared the vaccine to pneumococcal vaccine, polyvalent [23-valent] (PPSV23) in those aged 50 years and above.
The approval was further supported by outcomes from the Phase III STRIDE-4, STRIDE-5, STRIDE-6 and STRIDE-7 trials. The vaccine is administered as a single dose.
MSD Research Laboratories Global Clinical Development infectious diseases and vaccines senior vice-president Dr Paula Annunziato stated: “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 development follows MSD’s exclusive licence agreement with Jiangsu Hengrui Pharmaceuticals for the investigational oral small molecule lipoprotein(a) [Lp(a)] inhibitor, HRS-5346.
