Merck's Investigational 21-Valent Pneumococcal Conjugate Vaccine V116 Receives FDA Priority Review for Adult Use

▎Edited by the WuXi AppTec content team

Recently, MSD announced that the U.S. FDA has accepted the Biologics License Application (BLA) for its 21-valent pneumococcal conjugate vaccine V116, specifically designed to prevent invasive pneumococcal disease and pneumococcal pneumonia in adults, and will conduct a priority review. The FDA has set June 17, 2024, as the PDUFA goal date. According to the press release,If approved, V116 will become the first pneumococcal conjugate vaccine specifically designed for adults.。

This BLA submission is partially based on data from the STRIDE-3 trial, a pivotal Phase 3 clinical trial that evaluated the immunogenicity, tolerability, and safety of V116 compared to the active comparator PCV20 (Pneumococcal 20-valent Conjugate Vaccine) in adults who had not previously received a pneumococcal vaccine. The results of the STRIDE-3 trial were presented at the World Vaccine Congress West Coast held in November 2023. The primary endpoint of the trial...Analysis shows

According to the measurement results of serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) on Day 30, in adults aged 50 years and older (Cohort 1), the immune response induced by V116 demonstrated non-inferiority across all 10 serotypes shared with the active comparator. Based on the assessment of OPA GMTs on Day 30 and the proportion of participants with a ≥4-fold increase in OPA from Day 1 to Day 30, 10 out of the 11 serotypes contained in V116 showed robust immune responses; these 11 serotypes are not included in the active comparator vaccine. Additionally, based on the evaluation of serotype-specific OPA GMTs 30 days post-vaccination, the immune response elicited by V116 demonstrated non-inferiority in adults aged 18–49 years (Cohort 2) compared to adults aged 50–64 years.

In addition, the BLA for V116 is supported by several other Phase 3 clinical study results (including STRIDE-4, STRIDE-5, and STRIDE-6), which evaluated the application of V116 in adult patient populations who have never been vaccinated and those with prior vaccination experience.

V116 is an investigational 21-valent pneumococcal conjugate vaccine currently in Phase 3 clinical development. V116 is specifically designed to prevent the serotypes of Streptococcus pneumoniae that primarily cause pneumococcal disease in adults, including eight unique serotypes. V116 is formulated as a single-dose administration to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults.

According to data from the U.S. Centers for Disease Control and Prevention (CDC) from 2018-2021V116 covers approximately 83% of invasive pneumococcal disease serotypes in people aged 65 and over.V116 includes eight unique serotypes not covered by currently licensed pneumococcal vaccines (15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B), according to the same data from the CDC, these serotypes are responsible for approximately 30% of invasive pneumococcal disease in adults aged 65 and older.

[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，Retrieved December 20, 2023 from https://www.businesswire.com/news/home/20231219406441/en

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