FDA Grants Priority Review to New Biologics License Application for V116 Against Pneumococcal Disease

If approved, V116 would offer significant improvements in safety and effectiveness for the prevention of pneumococcal disease.

The FDA has granted priority review to a new biologic license application (BLA) for V116 (Merck and Co), an investigational 21-valent pneumococcal conjugate vaccine designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults, according to a press release. If approved, the vaccine would offer significant improvements in safety and effectiveness for the prevention of pneumococcal disease.¹

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“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, senior vice president and head of global clinical development and chief medical officer at Merck Research Laboratories, said in the 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

The FDA has set a Prescription Drug User Fee Action date for June 17, 2024, according to the press release.

The BLA was based on results from the STRIDE-3 phase 3 trial, evaluating immunogenicity, tolerability, and safety of V116 compared to pneumococcal 20-valent conjugate vaccine (PCV20, Prevnar; Pfizer) for adults who had not previously received a vaccine against pneumococcal disease.¹ The trial was randomized and double-blinded and included adults aged 18 years and older. In the study, individuals received a dose of either V116 or PCV20 in 2 cohorts: those aged 50 and older and those aged 19 to 49.²

About The STRIDE-3 Trial

Trial Name: Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003)

ClinicalTrial.gov ID: NCT05425732

Sponsor: Merck Sharp & Dohme LLC

Completion Date: May 2023

The primary endpoints included safety, serotype-specific opsonophagocytic activity geometric (OPG) mean titers at 30 days after vaccination, and the percentage of individuals who reached greater than or equal to a 4-fold increase from baseline for serotype specific OPG.²

Investigators found that the immune responses elicited by the investigational vaccine were superior for 10 of 11 serotypes that were not included in PCV20 at 30 days. The responses for those aged 18 to 49 years were non-inferior to the immune responses in the age 50 to 56 years group.²

The safety in both cohorts was comparable, with at least 1 adverse event in 61.7% of those receiving V116 and 67.2% in those receiving PCV20. There were no serious vaccine-related responses or vaccine-related deaths in the study, according to the results.²

Results for the STRIDE-3 trial were presented at the World Vaccine Congress West Coast in November 2023, according to the press release. The BLA is also supported by results from other phase 3 trials, including individuals who are vaccine naïve and vaccine experienced. The trials included STRIDE-3, STRIDE-4 (NCT05464420), STRIDE-5 (NCT05526716), STRIDE-6 (NCT05420961). Results from the additional trials will be shared at future scientific congresses, according to Merck.²

The phase 3 program of V116 also includeSTRIDE-7 (NCT05393037), STRIDE-8 (NCT05696080), STRIDE-9 (NCT05633992) and STRIDE-10 (NCT05569954).²

References

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. News release. Merck. 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/
Gallagher A. Investigational Vaccine Has Non-Inferior Immune Response Compared to PCV20 for Pneumococcal Disease. Pharmacy Times. December 13, 2023. Accessed December 19, 2023. https://www.pharmacytimes.com/view/investigational-vaccine-has-non-inferior-immune-response-compared-to-pcv20-for-pneumococcal-disease