FDA Approves Merck’s 15-Valent Pneumococcal Vaccine

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Merck announced that FDA approved Vaxneuvance for active immunization for the prevention of invasive pneumococcal disease.

Merck, known as MSD outside the United States and Canada, announced on July 16, 2021 that FDA approved Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae (S. 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. Vaxneuvance is contraindicated for individuals with a history of severe allergic reaction (such as anaphylaxis) to any component of Vaxneuvance or to diphtheria toxoid.

S. pneumoniae (pneumococcus) is bacteria that cause pneumococcal disease. Different strains of these 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% of adult IPD occurs in adults 50 years of age and older. Serotypes 3, 22F, and 33F significantly contribute to IPD, and serotype 3 is the leading cause of IPD in adults in the United States.

The approval of Vaxneuvance was based on data from seven randomized, double-blind clinical studies, which assessed safety, tolerability, and immunogenicity in adults. Clinical data showed that immune responses were not inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes (assessed by opsonophagocytic activity geometric mean titers).

Immune responses for Vaxneuvance were superior to PCV13 for shared serotype 3 and for the two serotypes unique to Vaxneuvance, 22F and 33F. However, randomized controlled trials assessing the clinical efficacy of Vaxneuvance compared to PCV13 have not been conducted.


The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is expected to meet in October 2021 to discuss and make recommendations on the use of Vaxneuvance in adults.

Source: Merck (MSD)