FDA approval of CAPVAXIVE will enhance protection against pneumococcal disease in older adults: GlobalData

The FDA has approved Merck’s CAPVAXIVE (pneumococcal 21-valent conjugate vaccine, originally known as V116), for preventing invasive pneumococcal disease and pneumococcal pneumonia in adults aged 18 years and older. This is the first pneumococcal vaccine that is specifically designed to protect against serotypes which particularly infect older adults. The vaccine will likely become the standard of care for use in older adults, says GlobalData.

Data has shown that the serotypes included in this vaccine are responsible for approximately 84 per cent of invasive pneumococcal disease in adults aged 50 years and older. The vaccine covers 21 serotypes, including eight that are not targeted by any other available pneumococcal vaccines, specifically serotypes 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B.

Anaelle Tannen, Infectious Disease Analyst at GlobalData comments: “Pneumococcal disease is a serious bacterial infection caused by Streptococcus pneumoniae and can lead to severe cases of pneumonia, sepsis, or meningitis. Adults aged over 65 years are at an increased risk of pneumococcal disease and thus CAPVAXIVE is positioned to be the standard of care vaccine used by physicians to provide protection in older adults. As the vaccine incorporates more of the serotypes responsible for pneumococcal disease in this age group, it addresses an important unmet need.”

CAPVAXIVE demonstrated robust immune responses in both vaccine-naïve and vaccine-experienced adult populations across four phase III studies including the STRIDE-3 (NCT05425732), STRIDE-5 (NCT05526716) and STRIDE-6 (NCT05420961) trials*. The vaccine was well tolerated, with few side effects reported. CAPVAXINE is also conveniently administered in a single shot.

The current vaccines already available to the adult population include pneumococcal conjugate vaccines (such as PCV15 and PCV20) and the pneumococcal polysaccharide vaccine (PPSV23). However, these vaccines do not cover all the serotypes that affect the older population and thus CAPVAXIVE provides an obvious benefit.

GlobalData estimates that, for the adult population, the number of pneumococcal vaccinations administered in the US will reach over 58 million by 2028.

Tannen concludes, “Invasive pneumococcal disease can lead to complications including hospitalisation, organ damage and death. Due to its broader serotype coverage, CAPVAXIVE has the potential to save countless lives from invasive pneumococcal disease and pneumococcal pneumonia and greatly reduce the burden of disease on society.”

*The STRIDE-3 trial assessed CAPVAXIVE in pneumococcal vaccine-naïve adults, the STRIDE-5 trial assessed CAPVAXIVE when administered concomitantly with influenza vaccine in adults 50 years of age and older, and the STRIDE-6 trial assessed CAPVAXIVE in vaccine-experienced adults.

Edits made by EP News Bureau