FDA Grants Breakthrough Designation to Merck's Investigational Pneumococcal Conjugate Vaccine Candidate

The FDA has awarded Breakthrough Therapy Designation to V116, Merck’s novel 21-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B in individuals 18 years of age and older.

The designation was based on results from a 2-part, randomized, comparator-controlled, double-blind phase 1/2 study (NCT04168190) of the vaccine. Phase 1 of the trial evaluated the safety, tolerability, and immunogenicity of a single dose in pneumococcal vaccine-naïve adults aged 18 to 49 years, whereas phase 2 analyzed V116 in individuals 50 years of age and older.

Full results of the V116-001 study are expected to be presented at the International Symposium on Pneumococci and Pneumococcal Diseases in June.

“V116 is specifically designed to address strains of disease-causing pneumococcal bacteria that are most prevalent in adults, reflecting our population-specific approach to developing pneumococcal conjugate vaccines. V116 targets serotypes that account for 85% of all invasive pneumococcal disease in individuals aged 65 and over in the United States as of 2019 and it includes 8 serotypes not covered by currently licensed vaccines,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, in a press release. “We look forward to discussing the ongoing development of this investigational vaccine, including the approach for Phase 3 studies, with the FDA and other regulatory agencies.”

Phase 3 clinical trials for the candidate are expected to begin later this year, according to Merck.

Reference

Merck Announces U.S. FDA has Granted Breakthrough Therapy Designation for V116, the Company’s Investigational 21-Valent Pneumococcal Conjugate Vaccine, for the Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults. Merck. News release. April 14, 2022. https://www.merck.com/news/merck-announces-u-s-fda-has-granted-breakthrough-therapy-designation-for-v116-the-companys-investigational-21-valent-pneumococcal-conjugate-vaccine-for-the-prevention-of-invasive-pneumococ/