Merck’s new BLA for pneumococcal conjugate vaccine granted priority review

Merck announced the FDA has accepted for priority review a new Biologics License Application – BLA – for V116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults. The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition. The FDA has set a target action date, of June 17, 2024. The BLA for V116 is based, in part, on data from STRIDE-3, a pivotal Phase 3 trial which evaluated the immunogenicity, tolerability and safety of V116 compared to PCV20 – pneumococcal 20-valent conjugate vaccine – in adults who had not previously received a pneumococcal vaccine. The BLA for V116 is supported by results from multiple Phase 3 clinical studies evaluating V116 in both vaccine-naive and vaccine-experienced adult patient populations. The serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 years of age and older. V116 includes eight unique serotypes not covered by currently licensed pneumococcal vaccines, which were responsible for approximately 30% of invasive pneumococcal disease in individuals 65 years of age and older, based on the same CDC data.