FDA Grants Priority Review to Merck's 21-Valent Pneumococcal Vaccine V116 for Adults

The FDA has granted priority review to Merck's V116, a novel 21-valent pneumococcal vaccine designed for adults. Incorporating eight unique serotypes absent in existing vaccines, V116 shows promise based on robust Phase 3 trial data. This development represents a crucial stride in preventing adult pneumococcal disease.

Merck has announced that the U.S. Food and Drug Administration (FDA) has prioritized the review of its innovative 21-valent pneumococcal conjugate V116 vaccine. This significant advancement in adult immunization targets 83% of invasive pneumococcal disease (IPD) cases in older adults. If approved by June 2024, this pioneering vaccine, specifically formulated for adults, could represent a major breakthrough in combating IPD.

A Crucial Step in Protecting Elderly Health

Dr. Eliav Barr, Senior Vice President and CMO at Merck RL, highlighted the significance of V116, “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. If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease.”

Advancing Adult Immunization Against IPD

The decision by the FDA underscores the potential of V116 to dramatically improve adult health. The vaccine covers 21 serotypes of the Streptococcus pneumoniae bacteria, which are responsible for approximately 83% of IPD cases in individuals aged 65 and older, based on CDC data from 2018-2021. Notably, V116 includes eight unique serotypes not covered by current pneumococcal vaccines, addressing around 30% of IPD cases in this age group.

Latest Findings from STRIDE-3 Trial

Merck anounced its commitment to advancing adult vaccination is evident in the comprehensive data supporting V116's Biologics License Application and it includes findings from multiple Phase 3 trials, notably the STRIDE-3 trial. This pivotal study compared the immunogenicity, tolerability, and safety of V116 with the existing PCV20 (pneumococcal 20-valent conjugate vaccine) in adults who had not previously received a pneumococcal vaccine. The promising results of STRIDE-3 were presented at the World Vaccine Congress West Coast in November 2023.

The FDA's Prescription Drug User Fee Act (PDUFA) target action date for V116 is set for June 17, 2024. This expedited review process is reserved for treatments and vaccines that could significantly enhance safety or effectiveness in addressing serious conditions.  V116 represents a significant advancement in adult vaccination, poised to combat pneumococcal diseases. Ongoing trials, including STRIDE-4, STRIDE-5, and STRIDE-6, are expected to provide more data, underscoring the vaccine's role in enhancing public health, especially for the elderly.