In June 2024 Merck (known as MSD outside the US and Canada) announced that the FDA has approved CAPVAXIVE for the prevention of invasive disease and pneumonia caused by specific Streptococcus pneumoniae serotypes that cause most invasive pneumococcal disease (IPD) cases. The vaccine has been approved for use in adults and targets serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B. The CDC’s Advisory Committee on Immunisation Practices is expected to meet this month to discuss recommendations for the use of CAPVAXIVE in adults.
Targeting new serotypes
Merck used CDC data to inform serotype selection. In adults aged 50 and older, CAPVAXIVE covers the serotypes responsible for around 84% of IPD cases, which compares to approximately the 52% covered by PCV20 (pneumococcal 20-valent conjugate vaccine). In adults aged 65 and older, CAPVAXIVE covers the serotypes responsible for approximately 85% of IPD cases, compared to around 51% covered by PCV20.
CAPVAXIVE incorporates eight unique serotypes that are not covered by other currently approved pneumococcal vaccines: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. Dr Walter Orenstein, professor emeritus of medicine, epidemiology, global health, and paediatrics at Emory University and member of Merck’s Scientific Advisory Committee, suggested that “complications from invasive pneumococcal disease can lead to hospitalisation, organ damage, and even death”.
“CAPVAXIVE is designed to include the serotypes that cause the majority of invasive pneumococcal disease in adults, helping to protect adults against invasive pneumococcal disease and pneumococcal pneumonia.”
Dr Dean Y. Li, president, Merck Research Laboratories, stated that the approval is a “testament to our population-specific strategy behind CAPVAXIVE, which demonstrated robust immunogenicity in a range of adult populations” and is “driven by a deep understanding of pneumococcal disease”.
“We are proud to provide CAPVAXIVE as a new option specifically designed to help protect against the majority of invasive pneumococcal disease-causing serotypes in adults.”
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