The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to V116 for the prevention of invasive pneumococcal disease 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 adults 18 years of age and older.
V116 is an investigational 21-valent pneumococcal conjugate vaccine. The designation was based on data from a 2-part randomized, comparator-controlled, double-blind phase 1/2 study (V116-001; ClinicalTrials.gov Identifier: NCT04168190) that evaluated the safety, tolerability, and immunogenicity of a single intramuscular injection of V116 in pneumococcal-naïve adults 18 to 49 years of age (phase 1) and in pneumococcal-naïve adults 50 years of age and older (phase 2).
“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,” said Dr Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “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.”
Full study data are planned for presentation at the upcoming International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in June 2022. The Company expects to initiate phase 3 clinical trials for V116 later this year.
Merck announces US 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. News release. Merck Inc. Accessed 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/