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# Expanded Indication for Merck’s Vaxneuvance
- URL: https://www.fdaweb.com/expanded-indication-for-mercks-vaxneuvance/
- Published: 2022-06-22T12:00:00.000Z
- Updated: 2026-09-14T17:49:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152124

FDA has approved an expanded indication for Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) to include children six weeks through 17 years of age. The vaccine is indicated 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.

Approval was based on data from seven randomized, double-blind clinical studies assessing the vaccine’s safety, tolerability and immunogenicity in infants, children and adolescents, according to the company. It says data from the pivotal study “showed that immune responses elicited by Vaxneuvance following a four-dose pediatric series were non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes based on serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs).” A secondary analysis also showed that immune responses for the vaccine were superior to PCV13 for shared serotype 3 and the two serotypes unique to Vaxneuvance, 22F and 33F, it adds.