Following priority review, the FDA has approved Merck & Co (MSD)’s Capvaxive (pneumococcal 21-valent conjugate vaccine, originally known as V116), for the prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia in adults ages 18 years and older. This is the first pneumococcal vaccine that is specifically designed to protect against the serotypes that primarily infect older adults. Data has shown that the serotypes included in this vaccine are responsible for approximately 84% of IPD 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.

Pneumococcal disease is a serious bacterial infection caused by Streptococcus pneumoniae. Pneumococcal infections can broadly be classified into one of two types. In non-invasive pneumococcal disease, the infection does not penetrate normally sterile sites, such as the blood or cerebrospinal fluid. Infections tend to be mild in severity and can often resolve without treatment. Examples of these include otitis media and sinusitis. IPD refers to more severe infections in which the bacterium is isolated from specimens taken from normally sterile sites. These include serious and potentially fatal infections, such as meningitis, septicemia, and pneumonia. IPD is a leading cause of mortality and morbidity globally. IPD rates are highest in children ages younger than five years, immunocompromised individuals with chronic diseases such as HIV infection, and individuals aged 65 years and older.

Capvaxive is positioned to become the standard-of-care vaccine used by physicians to protect older adults because the vaccine incorporates more of the serotypes responsible for pneumococcal disease in this age group, and thus it addresses an important unmet need. Due to Capvaxive’s broader serotype coverage, the vaccine has the potential to save countless lives from IPD and pneumococcal pneumonia and greatly reduce the burden of disease on society. 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 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. The vaccine was well tolerated, with few side effects reported. Capvaxive is also conveniently administered in a single shot.

GlobalData estimates that, for the adult population, the number of pneumococcal vaccinations administered in the US will reach over 58 million by 2028. Other vaccines already available to the adult population include pneumococcal conjugate vaccines such as MSD’s PCV15 and Pfizer’s PCV20, and the pneumococcal polysaccharide vaccine (MSD’s PPSV23).

However, these vaccines do not cover all the serotypes that affect the older population, and thus Capvaxive provides an obvious benefit.

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