FDA Approves Merck’s 15-valent Pneumococcal Vaccine
The FDA recently approved Vaxneuvance, Merck’s 15-valent pneumococcal conjugate vaccine, for adults aged 18 years or older. The vaccine, formerly known as V114, is 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.

The CDC’s Advisory Committee on Immunization Practices (ACIP) is expected to meet in October to make recommendations for the use of Vaxneuvance in adults, Merck said. The vaccine is contraindicated for patients with a history of severe allergic reactions to any component of the vaccine or to diphtheria toxoid, the company noted.

The FDA approval was based on data from seven randomized, double-blind clinical studies, which showed that the vaccine was noninferior to the 13-valent pneumococcal conjugate vaccine (PCV13) for 13 shared serotypes. Immune responses were superior to PCV13 for serotype 3 and for two serotypes unique to Vaxneuvance, 22F and 33F, Merck said.

“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,” Jose F. Cardona, MD, principal investigator for the Indago Research & Health Center and coordinating investigator for the clinical trial, said in a news release. “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.”

Randomized controlled studies assessing the clinical efficacy of Vaxneuvance compared with PCV13 have not been conducted. The vaccine is also being tested in children in phase 3 trials.