An innovative pneumococcal conjugate vaccine for adults is approaching approval, offering potential clinical value to a range of adult populations. Merck’s investigational 21-valent pneumococcal conjugate vaccine, V116, has shown positive data from multiple Phase 3 studies, as announced at the 13th Meeting of the International Society of Pneumonia and Pneumococcal Diseases (ISPPD) in Cape Town, South Africa.

The vaccine, V116, has been found to be immunogenic for all 21 serotypes covered by the vaccine in various adult populations, including those who had not previously received a pneumococcal vaccine, those who had previous experience with such vaccines, and those at an increased risk of pneumococcal disease, such as people living with HIV. Across the studies presented, V116 elicited higher immune responses than the studied comparators for the serotypes unique to V116.

These positive results have led to a recent filing submission to the U.S. Food and Drug Administration (FDA), which granted V116 priority review with a Prescription Drug User Fee Act of June 17, 2024. If approved, V116 would be the first pneumococcal conjugate vaccine designed specifically for adults.

Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, expressed confidence in the potential clinical value V116 could provide to adult populations. He stated, ‘We are encouraged by the results of these studies showing that V116 has generated immune responses to the serotypes responsible for most adult invasive pneumococcal disease.’

Additionally, preliminary data from the real-world evidence study in the U.S., Pneumococcal Pneumonia Epidemiology, Urine Serotyping, and Mental Outcomes (PNEUMO), revealed that among 2,065 adults 50 years of age and older hospitalized with community-acquired pneumonia between 2018 and 2022, 242 pneumococcal serotypes were detected. Approximately 84% of these serotypes were covered by V116.