FDA grants priority review to new BLA for V 116, an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults
Merck Inc., known as MSD outside of the United States and Canada, announced the FDA has accepted for priority review a new Biologics License Application (BLA) for V 116, 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 Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024.
“Invasive pneumococcal disease poses a greater risk to older adults or those with weakened immune systems, in part due to disease-causing serotypes not covered by currently licensed pneumococcal conjugate vaccines,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “If approved, V 116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease. We look forward to discussing the data that support our filing with the FDA and are working with urgency to bring this potential new preventative measure to adult patients.”
The BLA for V 116 is based, in part, on data from STRIDE-3, a pivotal Phase III trial which evaluated the immunogenicity, tolerability and safety of V 116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults who had not previously received a pneumococcal vaccine. Results from the STRIDE-3 trial were presented at the World Vaccine Congress West Coast in November 2023. The BLA for V 116 is supported by results from multiple Phase III clinical studies evaluating V 116 in both vaccine-naïve and vaccine-experienced adult patient populations, including STRIDE-3, STRIDE-4, STRIDE-5 and STRIDE-6. Results from additional trials will be shared with the scientific community at future congresses.
According to CDC data from 2018-2021, the serotypes covered by V 116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 years of age and older. V 116 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.
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