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Biologics License Application for 21-Valent Pneumococcal Vaccine Granted FDA Priority Review

Merck’s Biologics License Application for V116, a 21-valent pneumococcal conjugate vaccine, was given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024.

The FDA has granted priority review to Merck’s Biologics License Application (BLA) for V116, a novel 21-valent pneumococcal conjugate vaccine developed as a single dose for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. The BLA has been given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024.1

“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,” Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said in a press 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.”1

There are more than 100 different serotypes of pneumococcal bacteria that may affect adults differently than children.1 Those with a greater risk of infection include older adults and patients with certain chronic or immunocompromising health conditions, such as heart disease, lung disease, and liver disease. Mortality from invasive pneumococcal disease is highest among those aged 50 years and older.1

V116 includes eight serotypes that are not currently approved by pneumococcal vaccines, including 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. Those serotypes were responsible for approximately 30% of invasive pneumococcal disease in those aged 65 years and older. Pre-pandemic 2019 data from the CDC indicate that the 21 serotypes covered by the V116 vaccine are responsible for 85% of invasive pneumococcal disease in adults 65 years of age and older.

The FDA based its priority review status for V116, in part, on data from the pivotal Phase III STRIDE-3 trial. The study analyzed the immunogenicity, tolerability, and safety of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults who have yet to receive pneumococcal immunization.

The randomized, double-blind, active comparator-controlled study was designed to analyze the safety, tolerability, and immunogenicity of V116 vs. PCV20 for individuals 18 years of age and older. Participants were administered a single dose of either vaccine.

The trial’s primary endpoints included safety, serotype-specific opsonophagocytic activity geometric (OPG) mean titers at 30 days post vaccination, and percentage of patients greater than or equal to a 4-fold increase from baseline for serotype-specific OPG. The trial evaluated cohorts of patients aged 50 to 64 years and those aged 18 to 49 years.

In adults aged 50 years or older, V116 showed a non-inferior immune response compared to the PCV20 for all 10 common serotypes.2 The study showed that the immune responses produced by V116 were superior for 10 of 11 serotypes included in V116 but not included in PCV20, measured by OPA GMTs at 30 days, as well as the proportion of patients showing greater than or equal to a four-fold increase in OPA from day one to day 30. For those aged 18 to 49 years, V116 produced a non-inferior immune response compared to those aged 50 to 64 years.

In terms of safety, 61.7% of those administered V116 and 67.2% of those administered PCV20 reported at least one adverse event (AE). There were no serious vaccine-related AEs or vaccine-related deaths in the study.2


1. FDA Grants Priority Review to Merck’s New Biologics License Application for V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults. Merck. News release. December 19, 2023. Accessed December 19, 2023. https://www.merck.com/news/fda-grants-priority-review-to-mercks-new-biologics-license-application-for-v116-an-investigational-21-valent-pneumococcal-conjugate-vaccine-specifically-designed-to-protect-adults/

2. Merck announces V116, an investigational, 21-valent pneumococcal conjugate vaccine specifically designed for adults, met key immunogenicity and safety endpoints in two phase 3 trials. Merck. News release. July 27, 2023. Accessed December 19, 2023. https://www.merck.com/news/merck-announces-v116-an-investigational-21-valent-pneumococcal-conjugate-vaccine-specifically-designed-for-adults-met-key-immunogenicity-and-safety-endpoints-in-two-phase-3-trials/


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