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Merck MRK announced that the European Commission (“EC”) has approved its 21-valent pneumococcal conjugate vaccine (“PCV”), Capvaxive, for the prevention of invasive pneumococcal disease (“IPD”) and pneumococcal pneumonia in individuals aged 18 years and above.
The FDA had approved Capvaxive for 21 serotypes, which account for 84% of all IPDs in older adults, in June 2024.
The EC nod for Capvaxive marks the fourth authorization of the vaccine for the prevention of IPD and pneumococcal pneumonia in adults. Capvaxive is also approved in Canada and Australia.
Capvaxive targets serotypes that account for approximately 84% of all IPD in older adults (50 years and older) in the United States, including eight serotypes not covered by currently licensed vaccines.
Year to date, shares of Merck have plunged 11.5% against the industry’s rise of 4.4%.
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More on the EC's Nod for MRK's Capvaxive
The EC’s nod for Capvaxive was based on safety and immunogenicity data from the STRIDE clinical program.
Among these are data from the phase III STRIDE-3 study, which evaluated Capvaxive compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults aged 18 years and above who had not previously received a pneumococcal vaccine.
It also included data from the phase III STRIDE-4, STRIDE-5, STRIDE-6, STRIDE-7 and STRIDE-10 studies, which investigated Capvaxive in vaccine-naïve and vaccine-experienced adults.
The EC’s approval for Capvaxive was expected, as, in January, the Committee for Medicinal Products for Human Use had recommended the approval of Capvaxive for the prevention of IPD and pneumococcal pneumonia in individuals aged 18 years and older.
Other Players in the PCV Space
Pfizer PFE is a key player in the PCV vaccine space.
PFE markets Prevnar 20, which is approved for the prevention of IPD caused by 20 serotypes in individuals aged six weeks and older. PFE also markets Prevnar 13, which contains 13 serotypes and has the FDA’s approval for use in individuals aged six weeks and older.
Pfizer recorded $6.4 billion from combined sales of Prevnar 13 and Prevnar 20 in 2024.
Sanofi SNY has expanded its existing agreement with SK bioscience to develop, license and commercialize next-generation PCVs for treating IPD in pediatric and adult patient populations in December 2024.
The latest deal builds on the existing collaboration between SNY and SK bioscience to develop and commercialize a 21-valent PCV (PCV21) for the pediatric patient population. Per the expanded collaboration agreement, Sanofi and SK bioscience will jointly fund all research and development costs to support the launch of PCV21 and next-generation vaccines.