The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for V114 (Merck), an investigational 15-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease in adults aged 18 years and older.
The V114 vaccine candidate consists of pneumococcal polysaccharides from 15 serotypes, including serotypes 22F and 33F, which are associated with invasive pneumococcal disease and are not contained in the pneumococcal conjugate vaccines currently approved for adults. The BLA submission is supported by data from the Company’s clinical development program which consisted of phase 2 and 3 studies that assessed the efficacy and safety of V114 in healthy adults and those at increased risk of pneumococcal disease (eg, chronic medical conditions, 65 years and older).
The double-blind, active comparator-controlled phase 3 studies, PNEU-PATH and PNEU-DAY, compared the safety, tolerability and immunogenicity of V114 to PCV13 (Prevnar® 13). The PNEU-PATH study included 652 healthy adults aged 50 years or older who received V114 or PCV13 followed by Pneumovax® 23 one year later. The PNEU-DAY study included 1514 adults aged 18 to 49 years at increased risk of pneumococcal disease who received V114 or PCV13 followed by Pneumovax 23 six months later.
Results from the PNEU-PATH study demonstrated comparable immune responses following vaccination with Pneumovax 23 in both treatment groups for the 15 serotypes in V114. Additionally, findings from both studies showed that V114 generated immune responses comparable to PCV13 for the 13 shared serotypes and higher immune responses for serotypes 22F and 33F (the 2 serotypes not included in PCV13) at 30 days post-vaccination, based on opsonophagocytic activity responses. As for safety, V114 was found to be generally well tolerated in both studies with a safety profile consistent with that seen in previous trials.
A Prescription Drug User Fee Act (PDUFA) target date of July 18, 2021 has been set for this application.
The FDA has also granted Breakthrough Therapy designation to V114 for the prevention of invasive pneumococcal disease in pediatric patients aged 6 weeks to 18 years and adults 18 years and older.
For more information visit merck.com.
U.S. FDA accepts for Priority Review the Biologics License Application for V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for use in adults 18 years of age and older. [press release]. Kenilworth, NJ: Merck; January 12, 2021.