The U.S. Food and Drug Administration granted Merck’s investigational 21-valent pneumococcal conjugate vaccine (V116) Breakthrough Therapy Designation. The vaccine is for the prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia.

It is specifically designed to target 21 serotypes that cause more than 85% of all invasive pneumococcal disease cases in people 65 and over in the U.S. The designation is for adults 18 years of age and older.

The company plans to initiate Phase III trials for V116 later this year. The FDA made its decision based in part on data from the Phase I/II V116-001 trial that evaluated a single dose of the vaccine in pneumococcal vaccine-naïve adults 18-49 years of age (Phase I) and 50 years of age and older (Phase II). The company plans to present full results from those studies in June 2022 at the International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). The Breakthrough Therapy Designation was developed to expedite the development and review of drugs and therapies for serious or life-threatening conditions. The preliminary data must show the product is substantially better over currently available options for at least one clinically significant endpoint. Read more here.