Merck Announces U.S. FDA has Granted Breakthrough Therapy Designation for V116, the Company’s Investigational 21-Valent Pneumococcal Conjugate Vaccine
The FDA’s decision was informed by data from a two-part randomized, comparator-controlled, double-blind Phase 1/2 study, V116-001 (NCT04168190), 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.
“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 20191 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. “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.”
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.
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.
April 15, 2022
