On Jul. 16, 2021, Merck announced the U.S. Food and Drug Administration (FDA) had approved VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. The approval followed the FDA’s Priority Review of Merck’s application.

The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) was expected to meet in October to discuss and make recommendations on the use of VAXNEUVANCE in adults.

VAXNEUVANCE was approved based on data from seven randomized, double-blind clinical studies assessing safety, tolerability, and immunogenicity in adults. Clinical data showed that immune responses elicited by VAXNEUVANCE were non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes, as assessed by opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs).

Pneumococcal disease is an infection caused by bacteria called Streptococcus pneumoniae, or pneumococcus. Different strains of this bacteria are called serotypes. Invasive pneumococcal disease (IPD) occurs when the bacteria infect parts of the body that are usually free from germs. Approximately 80 percent of all adult IPD burden is among adults 50 years of age and older. Serotypes 3, 22F and 33F contribute significantly to the burden of IPD, and serotype 3 is the leading cause of IPD in adults in the U.S.

VAXNEUVANCE was approved based on data from seven randomized, double-blind clinical studies designed to evaluate its safety, tolerability, and immunogenicity in 7,438 individuals from a variety of adult populations and clinical circumstances, 5,630 of whom received VAXNEUVANCE.