FDA Designates 15 Valent Pneumococcal Conjugate Vaccine Breakthrough Therapy


Merck has received a Breakthrough Therapy Designation for investigational 15-valent pneumococcal conjugate vaccine V114.

The US Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for V114, an investigational 15-valent pneumococcal conjugate vaccine developed by Merck.

The vaccine is under development for the prevention of invasive pneumococcal disease in pediatric populations of children 6 weeks to 18 years and in adults, as well.

“We are pleased with the data on V114 compiled to date, and we look forward to working closely with the FDA on the subsequent development of this investigational vaccine,” Nicholas Kartsonis, MD, senior vice president and head of vaccine and infectious diseases clinical research at Merck Research Laboratories, said in making the announcement.

According to Merck’s statement, the FDA’s decision was based on immunogenicity data from a phase 1/2 and a phase 2 study.

Study 005, a phase 1/2, multicenter, randomized, double-blind study, evaluated 4 distinct lots of a new formulation of the vaccine in healthy adults and infants, assessing the safety, tolerability, and immunogenicity profile of each lot.

Study 008, was a phase 2, proof-of-concept study in pediatric participants that sought to confirm the results of the first study in a larger population of infants.

In both studies, the vaccine was found to induce immune responses in infants for 2 serotypes, 22F and 33F, both of which are not contained in the currently available 13-valent pneumococcal conjugate vaccine. The studies also found the vaccine to be non-inferior for the serotypes in the currently available vaccine.

“The goal of our program in pediatric patients remains focused on providing additional serotype coverage versus currently available vaccines, while at the same time maintaining a strong immune response across all serotypes in the vaccine,” Dr. Kartsonis added in the statement.

The benefits of this designation include additional guidance from the FDA on an efficient drug development program, and assistance to help accelerate review time and eligibility for Accelerated Approval and Priority Review if relevant criteria are met.

V114 is currently being evaluated in phase 3 trials in both adult and pediatric populations.

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