Merck's 21-Valent Pneumococcal Conjugate Vaccine Capvaxive Approved in the European Union for Adult Use
MSD
Pharmaceutical R&D and Manufacturer
March 26, 2025, MSDAnnouncement issued,European Commission (EC) Approves MSD's 21-Valent Pneumococcal Conjugate Vaccine Capvaxive for the Prevention of Invasive Pneumococcal Disease in Adults (IPD`) and pneumococcal pneumonia`。Capvaxive is specifically designed for adults, covering the serotypes that cause approximately 84% of invasive pneumococcal disease in adults aged 50 and above.
The decision authorizesCapvaxiveIn allMarketing in 27 EU (European Union) member states as well as Iceland, Liechtenstein, and Norway. The vaccineIn various countriesThe launch time in the region will depend on various factors, including the completion of reimbursement procedures.Previously,Capvaxive has beenApproved in the U.S. in June 2024, the same yearApproved in Canada in July, and approved in Australia in January 2025.At the same time, it is undergoing regulatory review in Japan and other countries.
CapvaxiveTheEC Approval Based on Safety and Immunogenicity Data from the Phase 3 STRIDE Clinical Program.The study evaluatedImmunogenicity, Tolerability, and Safety of Capvaxive Compared with PCV20 (Pfizer's Pneumococcal 20-valent Conjugate Vaccine) in Adults Previously Unvaccinated Against Pneumococcus.
The analysis of the primary endpoint of the trial showed that, according to theMeasurement Results of 30-Day Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs): In adults aged 50 years and older (Cohort 1), Capvaxive demonstrated non-inferior immunogenicity across all 10 serotypes shared with the active comparator. Based on the 30-day OPA GMT measurements and the proportion of patients with ≥4-fold increases in OPA from Day 1 to Day 30, 10 out of the 11 serotypes included in Capvaxive showed robust immune responses; these 11 serotypes are not contained in the active comparator vaccine. Furthermore, based on the evaluation of serotype-specific OPA GMTs 30 days post-vaccination, the immune response elicited by Capvaxive in adults aged 18-49 years (Cohort 2) demonstrated non-inferiority compared to adults aged 50-64 years.
Data at the EU national level shows,AndCompared to PCV20,CapvaxiveSerotypes covered lead to adultsMore IPD Cases, as shown by the following four countries:
According toAccording to calculations by institutions such as PMI,As of 2024, the global pneumococcal vaccine market size is approximately USD 9.3-9.4 billion., and it is expected thatGrow to $14.5-18 billion by 2030, with a compound annual growth rate (CAGR) of approximately 4.2%-7.92%.
Currently,Pfizer and MSD are the main players in the global pneumococcal vaccine market., The two companies have engaged in a protracted battle in the pneumococcal vaccine field very early on.At the same time，Other players around the world are alsoProceedIn full swingThe research and development, such asVaxcyteAndGSK：
Vaxcyte's 31-valent candidate vaccine may shake up the landscape of the pneumococcal conjugate vaccine (PCV) field.。Last YearSeptemberA ComparisonPhase I/II Head-to-Head Data of Vaxcyte's VAX-31 vs. Prevnar 20Data,Research PromptsLeerink analysts predict that the candidate vaccine is "highly likely" to capture the majority of the market share by 2030.
GSKDue to increased competition, has terminated itsInvestA Lead Project from the Acquisition of Affinivax for $2.1 Billion——Phase 2 Clinical Study of 24-Valent Pneumococcal Candidate Vaccine AFX3772 in Adults,Turn toKey development still in the preclinical stagePneumonia vaccine with more than 30 valences，GSK expects to advance it into clinical trials in 2025.However, the phase 2 clinical study of AFX3772 for children is still ongoing.
High-End Pneumococcal Vaccine Showdown,Already inStaged.
References:
[1] MSD's Vaccine Under Development Shows Promise for EU Approval. WuXi AppTec. 2025-02-03.
[2] MSD's 21-Valent Pneumococcal Conjugate Vaccine Receives Positive Opinion from the EU. Vaccine Horizon. 2025-02-02.
[3] GSK and Pfizer Intensify Competition! GSK Abandons High-Priced Acquisition of Pneumonia Vaccine Pipeline | First on the Scene. R&D Guest. 2024-10-31.
[4] MSD Official Website.
