On Apr. 14, 2022, Merck announced that V116, the companyﾒs investigational 21-valent pneumococcal conjugate vaccine, had received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) 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. Phase 3 clinical trials for V116 were to be initiated later in the year.

The FDA’s decision was informed by data from a two-part randomized, comparator-controlled, double-blind Phase 1/2 study, V116-001, that assessed the safety, tolerability, and immunogenicity of a single dose of V116 in pneumococcal vaccine-naïve adults 18-49 years of age (Phase 1) and 50 years of age and older (Phase 2). Full results from the V116-001 study are planned for presentation at the upcoming International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in June.

The Breakthrough Therapy Designation is an FDA program designed to expedite the development and review of products intended for serious or life-threatening conditions. To qualify for this designation, preliminary clinical evidence must indicate that the product may demonstrate substantial improvement over currently available options on at least one clinically significant endpoint. The benefits of this Breakthrough Therapy Designation include more intensive guidance from the FDA on an efficient development program, access to a scientific liaison to help accelerate review time and potential eligibility for Priority Review if relevant criteria are met.