FDA approves Capvaxive (pneumococcal 21-valent conjugate vaccine) for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults
Merck Inc., known as MSD outside of the United States and Canada, announced that the FDA has approved Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for: i. Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older; ii. Active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older
Capvaxive is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease (IPD) cases. The approval follows the FDA’s Priority Review of Merck’s application. Do not administer Capvaxive to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of Capvaxive or to diphtheria toxoid.
This indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for the use of Capvaxive in adults.
This indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for the use of CAPVAXIVE in adults.
“Complications from invasive pneumococcal disease can lead to hospitalization, organ damage and even death. Many cases of adult disease are caused by serotypes not included in other approved pneumococcal conjugate vaccines,” said Dr. Walter Orenstein, professor emeritus of medicine, epidemiology, global health and pediatrics at Emory University and member of Merck’s Scientific Advisory Committee. 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.”
Based on CDC data from 2018-2021, the serotypes covered by Capvaxive are responsible for more cases of IPD in adults compared to PCV20 (pneumococcal 20-valent conjugate vaccine).i. In adults 50 years of age and older, Capvaxive covers the serotypes responsible for approximately 84% of IPD cases, compared to approximately 52% covered by PCV20. ii. In adults 65 years of age and older, Capvaxive covers the serotypes responsible for approximately 85% of IPD cases, compared to approximately 51% covered by PCV20. These values are based on CDC epidemiologic data and do not reflect the efficacy of the respective vaccines. There are currently no studies comparing the efficacy of Capvaxive and PCV20.
Capvaxive includes eight unique serotypes not covered by other currently approved pneumococcal vaccines; those serotypes were responsible for approximately 27% of IPD cases in adults 50 years of age and older and approximately 30% in adults 65 years of age and older, based on the same CDC data.
“Today’s 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,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “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.”
Among the clinical data supporting the approval are results from the pivotal Phase III STRIDE-3 trial (NCT05425732), which evaluated Capvaxive compared to PCV20 in adults 18 years of age and older who had not previously received a pneumococcal vaccine. The approval is also supported by results from the Phase III STRIDE-5 (NCT05526716) and STRIDE-6 (NCT05420961) trials evaluating CAPVAXIVE in vaccine-naïve and vaccine-experienced adults
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