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# FDA Approves Merck’s Pneumococcal Vaccine
- URL: https://www.fdaweb.com/fda-approves-mercks-pneumococcal-vaccine/
- Published: 2021-07-19T12:00:00.000Z
- Updated: 2026-09-14T17:06:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149732

FDA has approved Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for active immunization for preventing 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. Approval was based on data from seven randomized 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,” the company says. The vaccine is contraindicated for individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of Vaxneuvance or to diphtheria toxoid, it says.