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


V116 is a novel 21-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease and pneumococcal pneumonia.

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.


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/

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