Merck's V116 Pneumococcal Vaccine Earns FDA Priority Review for Enhanced Adult Protection

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Merck, also known as MSD outside the United States and Canada, has achieved a significant milestone in the development of its investigational 21-valent pneumococcal conjugate vaccine, V116, as reported in a press release. The US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for priority review, marking a crucial step towards addressing invasive pneumococcal disease and pneumococcal pneumonia in adults.

“The FDA’s decision to grant priority review for our V116 BLA is a significant milestone in our ongoing commitment to the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults,” Heather Platt, MD, distinguished scientist, global clinical development, vaccines, Merck, told Infection Control Today®. “V116 represents our population-specific approach with the goal of becoming the first approved pneumococcal conjugate vaccine specifically designed to address the serotypes that are the most prevalent in adults. If approved, we believe there is opportunity for V116 to provide clinical value for adult patients who have yet to be vaccinated—especially for older adults, who have a significant risk for pneumococcal pneumonia and invasive disease—as well as for those who are pneumococcal vaccine-experienced, due to the 8 unique serotypes for which V116 provides coverage.”

The FDA's decision to grant priority review to V116 underscores the vaccine's potential to significantly improve the safety and effectiveness of preventing serious conditions. A priority review designation expedites the regulatory assessment process and is typically reserved for treatments or vaccines that offer substantial advancements in addressing critical medical conditions. The target action date for the FDA's review is set for June 17, 2024, indicating the urgency of addressing pneumococcal diseases in adults.

Eliav Barr, MD, senior vice president, head of global clinical development, and chief medical officer at Merck Research Laboratories, emphasized the importance of V116 in addressing a critical health care challenge. Currently, available vaccines do not cover all disease-causing serotypes, leaving gaps in protection. V116 aims to bridge this gap and become the first pneumococcal conjugate vaccine tailored to combat the serotypes responsible for most adult invasive pneumococcal diseases.

The BLA for V116 builds on clinical trial data, including findings from the Phase 3 STRIDE-3 trial. This trial assessed V116's immunogenicity, tolerability, and safety compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults who had not previously received a pneumococcal vaccine. The BLA submission is further supported by results from multiple Phase 3 clinical studies involving both vaccine-naïve and vaccine-experienced adult patient populations.

V116's design addresses the serotypes predominantly responsible for adult pneumococcal disease, including eight unique serotypes not covered by currently licensed vaccines. These serotypes, such as 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B, account for approximately 30% of adult pneumococcal diseases. Moreover, V116 covers serotypes responsible for approximately 83% of invasive pneumococcal diseases in individuals aged 65 and older, based on CDC data from 2018-2021.

V116 is designed for easy administration as a single dose, providing a convenient and effective means to prevent invasive pneumococcal diseases and pneumococcal pneumonia in adults. The vaccine's development has been supported by an extensive Phase 3 program, comprising several clinical trials, denoted as STRIDE-3 to STRIDE-10.

Pneumococcal disease, caused by Streptococcus pneumoniae bacteria, poses serious health risks, including bacteremia, bacteremic pneumonia, meningitis, and noninvasive pneumonia. Vulnerable populations, including older adults and individuals with certain chronic or immunocompromising conditions, are at a heightened risk of infection. Mortality from invasive pneumococcal disease is particularly elevated among adults aged 50 and older.