Group 1: Merck's Capvaxive Approval - The European Commission has approved Merck's 21-valent pneumococcal conjugate vaccine, Capvaxive, for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in individuals aged 18 years and above [1][2] - Capvaxive targets serotypes responsible for approximately 84% of all invasive pneumococcal diseases in older adults in the United States, including eight serotypes not covered by currently licensed vaccines [2][3] - The approval was based on safety and immunogenicity data from the STRIDE clinical program, including phase III studies comparing Capvaxive to PCV20 [3][4] Group 2: Market Context and Competitors - Year to date, Merck's shares have decreased by 11.5%, while the industry has seen a rise of 4.4% [2] - Pfizer is a key competitor in the pneumococcal conjugate vaccine space, marketing Prevnar 20 and Prevnar 13, which generated $6.4 billion in combined sales in 2024 [5][7] - Sanofi has expanded its collaboration with SK bioscience to develop next-generation pneumococcal conjugate vaccines, including a 21-valent PCV for pediatric populations [8][9] - Vaxcyte is developing a 31-valent PCV, VAX-31, which is in mid-to-late-stage studies for preventing invasive pneumococcal disease in both pediatric and adult populations [10]
Merck Gets EC Nod for 21-Valent Pneumococcal Jab Capvaxive