V116 Could be the First Pneumococcal Conjugate Vaccine Designed for Adults

Merck today announced positive data from multiple Phase 3 studies evaluating V116, the company’s investigational, adult-specific 21-valent pneumococcal conjugate vaccine.

Across the clinical studies presented at the 13th Meeting of the International Society of Pneumonia and Pneumococcal Diseases in Cape Town, South Africa, on March 19, 2024, V116 was shown to be immunogenic for all 21 serotypes covered by the vaccine in a variety of adult populations, including those who had not previously received a pneumococcal vaccine (pneumococcal vaccine-naïve), those who had previously received a pneumococcal vaccine (pneumococcal vaccine-experienced) and those with an increased risk of pneumococcal disease, including people living with human immunodeficiency virus.

In all STRIDE studies presented at the meeting, V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116.

Several studies presented today were included in the filing submission to the U.S. Food and Drug Administration (FDA). The FDA granted V116 priority review with a Prescription Drug User Fee Act of June 17, 2024.

If approved by the FDA, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults.