U.S. FDA Accepts for Priority Review the Biologics License Application for Investigational 15-valent Pneumococcal Vaccine

The U.S. Food and Drug Administration (FDA) accepted for priority 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.

Merck announced the FDA set a Prescription Drug User Fee Act, or target action date, of July 18, 2021. 

Furthermore, Merck stated the European Medicines Agency is also reviewing an application for licensure of V114 in adults. Merck is also developing V114 for use in children.

“Invasive pneumococcal disease in adults is on the rise in many countries, driven by highly-invasive serotypes including serotype 3, which is included in the currently licensed pneumococcal conjugate vaccine, as well as serotypes not included, such as serotypes 22F and 33F,” said Dr. Roy Baynes, SVP and head of global clinical development, CMO, Merck Research Laboratories, in a press release issued on January 12, 2021.

“We look forward to working with the FDA during the review of this application.”

V114 is Merck’s investigational 15-valent pneumococcal conjugate vaccine candidate for the prevention of invasive pneumococcal disease in adults. V114 consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and includes serotypes 22F and 33F, which are commonly associated with invasive pneumococcal disease in older adults worldwide and are not contained in the pneumococcal conjugate vaccine currently licensed for use in adults.

V114 previously received Breakthrough Therapy Designation from the FDA for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks to 18 years of age and adults 18 years of age and older.

The BLA and priority review designation is 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. 

Additional studies in the BLA support the potential use of V114 in various real-world clinical settings, including in co-administration with the quadrivalent influenza vaccine and as part of a sequential administration with PNEUMOVAX 23, and demonstrate equivalent performance among consecutive lots of V114. 

The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition.

Visit Merck.com to learn more about Merck’s infectious diseases pipeline.

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