FDA Will Review BLA for Pneumococcal Conjugate Vaccine

The agency set a PDUFA date for July 18 for Merck's V114 vaccine.

The US Food and Drug Administration (FDA) will review a Biologics License Application (BLA) for V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in adults 18 years of age and older.

The FDA set a Prescription Drug User Fee Act (PDUFA) date for July 18, 2021.

“Building on our nearly 40 years of experience with PNEUMOVAX 23, Pneumococcal Vaccine Polyvalent, we have developed V114 as another potentially important option to help protect more adults from invasive pneumococcal disease, especially those who are at increased risk," Roy Baynes, MD, PhD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said. "We look forward to working with the FDA during the review of this application.”

The BLA and priority review designation are supported by results from phase 2 and Phase 3 clinical studies in a variety of adult populations, including healthy adults and those at increased risk, such as adults with chronic medical conditions, adults with HIV, and those 65 years of age and older.

Back in September, Merck announced results from its 2 phase 3 studies.

One of the phase 3 studies was the PNEU-AGE (V114-019) trial, which enrolled healthy adults 50 years of age or older. The trial demonstrated the vaccine was non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 serotypes targeted by both vaccines and superior for serotypes 22F and 33F, the two serotypes targeted by V114 but not PCV13.

The company’s other phase 3 trial, PNEU-TRUE (V114-020), also used healthy adults 50 years of age or older. The vaccine met its primary immunogenicity objective demonstrating equivalent immune response across all 15 serotypes for three different lots of V114.

In both studies, the vaccine was generally well tolerated, with a safety profile comparable to PCV13 and consistent with that observed for V114 in previously reported studies.

In addition to the FDA review, the European Medicines Agency is also reviewing an application for V114.