Merck recently received acknowledgment from the US Food and Drug Administration (FDA) regarding the priority review acceptance of its Biologics License Application (BLA) for the V116 pneumococcal vaccine. This investigational vaccine, a 21-valent pneumococcal conjugate vaccine, is specifically tailored to combat invasive pneumococcal disease and pneumococcal pneumonia among the adult population. The FDA’s decision to prioritize this review process aligns with its strategy to expedite the evaluation of medicines and vaccines that promise substantial enhancements in the treatment or prevention of critical conditions.
The assigned target action date for the FDA’s Prescription Drug User Fee Act (PDUFA) for V116 is June 17, 2024. The significance of this application review lies in V116 potentially marking the debut of a pneumococcal vaccine that distinctly targets the serotypes predominantly responsible for adult invasive pneumococcal disease. Dr. Eliav Barr, Merck Research Laboratories’ Senior Vice President, Head of Global Clinical Development, and Chief Medical Officer, emphasized the heightened risk older adults or individuals with weakened immune systems face due to disease-causing serotypes not covered by currently licensed pneumococcal vaccines.
The foundation of the BLA for V116 is rooted in various trials, notably the STRIDE-3 pivotal Phase 3 trial. STRIDE-3 was designed to evaluate the immunogenicity, tolerability, and safety of V116 in comparison to PCV20 (pneumococcal 20-valent conjugate vaccine) among adults without prior pneumococcal vaccination. Presented at the World Vaccine Congress West Coast in November 2023, the trial results corroborated the potential of V116. Additionally, Merck’s submission is bolstered by data from several Phase 3 clinical studies, including STRIDE-4, STRIDE-5, and STRIDE-6, encompassing both vaccine-naïve and vaccine-experienced adult populations.
New Pneumococcal Vaccine V116 Targets Offering Hope for Adult Disease Prevention
Notably, CDC data from 2018 to 2021 illustrates the significance of the serotypes covered by V116, accounting for approximately 83% of invasive pneumococcal disease among individuals aged 65 and above. Notably, V116 comprises eight distinct serotypes not addressed by currently licensed pneumococcal vaccines. These serotypes were responsible for around 30% of invasive pneumococcal disease in the same age group, based on CDC data from the same period.
This breakthrough in vaccine development signals a potential milestone in the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults, targeting the specific serotypes that pose a significant health risk in this demographic. The culmination of the V116 late-stage development program exhibits promising data, providing hope for critical medical intervention in adult pneumococcal disease prevention.
Resource: Merck, December 20, 2023
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