FDA grants Merck fast-track status for 15-valent pneumonia vaccine

Jan. 12, 2021

Merck, known as MSD outside the United States and Canada, announced the U.S. Food and Drug Administration accepted for priority review a Biologics License Application 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 target action date, of July 18, 2021. The European Medicines Agency is also reviewing an application for licensure of V114 in adults.

Merck developed V114 as an option to help protect more adults from invasive pneumococcal disease, especially those who are at increased risk.

The 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. 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.

Read the Merck statement