FDA approves supplemental indication for Vaxneuvance to include children 6 weeks through 17 years of age to prevent invasive disease caused by streptococcus pneumoniae.

Vaxneuvance is now indicated 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 individuals 6 weeks of age and older. The approval follows the FDA’s Priority Review of Merck’s supplemental application. Vaxneuvance is contraindicated for individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of Vaxneunvance to diphtheria toxoid; .

The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet to discuss and make recommendations on the use of Vaxneuvance in pediatric populations.

“Despite decreases in incidence of invasive pneumococcal disease in children, certain key serotypes continue to cause serious illness that can lead to death in children under the age of 5, with serotypes 3, 22F and 33F responsible for more than a quarter of all invasive pneumococcal disease cases in this population,” said Dr. Steven Shapiro, chairman, department of pediatrics, Jefferson Abington Hospital, and investigator for the PNEU-PED trial. “With the robust clinical data supporting Vaxneuvance and this FDA approval, Vaxneuvance will be an important new option to help advance protection for children.”