Merck, known as MSD outside the United States and Canada, announced the US Food and Drug Administration (FDA) 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 follows the FDA’s Priority Review of Merck’s application.

Vaxneuvance is contraindicated for individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of Vaxneuvance or to diphtheria toxoid; see additional Select Safety Information below.

The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is 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).

Additionally, immune responses for Vaxneuvance were superior to PCV13 for shared serotype 3 and for the two serotypes unique to Vaxneuvance, 22F and 33F. In the pivotal phase 3 PNEU-AGE (V114-019) study, superiority for Vaxneuvance relative to PCV13 was based on statistically significantly greater OPA GMT ratios for serotypes 22F [GMT Ratio 32.52 (95% Confidence Interval (CI) 25.87, 40.88)] and 33F [GMT Ratio 7.19 (95% CI 6.13, 8.43)], as well as for the key secondary objective assessing serotype 3 [GMT Ratio 1.62 (95% CI 1.40, 1.87)]. Randomized controlled trials assessing the clinical efficacy of Vaxneuvance compared to PCV13 have not been conducted.

“Some adults, including older adults or those with certain chronic medical conditions or immunocompromising conditions, are at increased risk for pneumococcal disease and its serious, sometimes life-threatening complications,” said Dr. Jose Cardona, Indago Research and Health Center, coordinating investigator for the PNEU-AGE trial. “The FDA’s approval of Vaxneuvance is based on robust phase 2 and 3 studies assessing immune responses in a broad range of adult populations and provides an important new option in protection from invasive pneumococcal disease.”