U.S. FDA approves CAPVAXIVE (V116), specifically designed for pneumococcal disease in adults

Merck has announced that the U.S. Food and Drug Administration (FDA) has approved CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for, active immunisation 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.

Along with, active immunisation 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.

According to the statement, 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.

“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 statement informs.

The U.S. Centres for Disease Control and Prevention’s (CDC) Advisory Committee on Immunisation Practices is expected to meet later this month to discuss and make recommendations for the use of CAPVAXIVE in adults.

“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,” said Dr Walter Orenstein, professor emeritus of medicine, epidemiology, global health and paediatrics at Emory University and member of Merck’s Scientific Advisory Committee.

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).

According to the data, in adults 50 years of age and older, CAPVAXIVE covers the serotypes responsible for approximately 84 per cent of IPD cases, compared to approximately 52 per cent covered by PCV20.

Where as, in adults 65 years of age and older, CAPVAXIVE covers the serotypes responsible for approximately 85 per cent of IPD cases, compared to approximately 51 per cent 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,” the release adds.

CAPVAXIVE includes eight unique serotypes not covered by other currently approved pneumococcal vaccines; those serotypes were responsible for approximately 27 per cent of IPD cases in adults 50 years of age and older and approximately 30 per cent in adults 65 years of age and older, based on the same CDC data.

Among the clinical data supporting the approval are results from the pivotal Phase 3 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 3 STRIDE-5 (NCT05526716) and STRIDE-6 (NCT05420961) trials evaluating CAPVAXIVE in vaccine-naïve and vaccine-experienced adults.