FDA Approves Merck's Vaxneuvance For Prevention Of Invasive Pneumococcal Disease In Children

The U.S. Food and Drug Administration has approved an expanded indication for Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) to include children 6 weeks through 17 years of age, Merck & Co., Inc. (MRK) said in a statement on Wednesday.

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.

Vaxneuvance is contraindicated for individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of Vaxneuvance or to diphtheria toxoid.

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

Invasive pneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae or pneumococcus.

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