The US Food and Drug Administration (FDA) has accepted for priority review a new Biologics License Application (BLA) for V116, Merck’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults. 

The BLA for V116 is based, in part, on data from STRIDE-3, a phase 3 trial that 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. 

Results from the STRIDE-3 trial were presented at the World Vaccine Congress West Coast in November. The BLA for V116 is supported by results from multiple phase 3 clinical studies evaluating V116 in both vaccine-naïve and vaccine-experienced adult patient populations, also including STRIDE-4, STRIDE-5, and STRIDE-6. Results from additional trials will be shared with the scientific community at future congresses, according to a release from Merck. 

“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,” says Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, in a release. “If approved, V116 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.”

According to Centers for Disease Control and Prevention data from 2018-2021, 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 Centers for Disease Control and Prevention data.

The FDA has set a Prescription Drug User Fee Act, or target action date, of June 17, 2024.

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