Merck’s 15-Valent Pneumococcal Conjugate Vaccine Vaxneuvance Receives FDA Priority Review for Use in Children and Adolescents

Recently, MSD announced that the U.S. FDA has granted Priority Review designation to the supplemental Biologics License Application (sBLA) for Vaxneuvance, a 15-valent pneumococcal conjugate vaccine, to help prevent invasive pneumococcal disease in children aged 6 weeks to 17 years.

Pneumococcal disease, caused by Streptococcus pneumoniae infection, affects children differently than adults. Children under 2 years of age are particularly susceptible to pneumococcal infections. Certain pneumococcal serotypes pose a greater threat to children, including serotypes 22F, 33F, and 3, which account for more than a quarter of all invasive pneumococcal disease cases in children under 5 years old.

Vaxneuvance is a 15-valent pneumococcal conjugate vaccine, composed of purified capsular polysaccharides from Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, conjugated to the CRM197 carrier protein. Vaxneuvance has been approved by the FDA for use in adults aged 18 years and older to prevent invasive diseases caused by the pneumococcal serotypes included in the vaccine. Vaxneuvance previously received Breakthrough Therapy Designation from the U.S. FDA for the prevention of invasive pneumococcal disease in pediatric patients aged 6 weeks to 18 years.

This application is based on positive data obtained from Phase 2 and Phase 3 clinical trials of the vaccine conducted in pediatric populations, including infants, children, and adolescents. For instance, a Phase 3 trial conducted in healthy infants (n=1720) aged 42-90 days met its primary endpoints for safety and immunogenicity. The safety profile of the four doses of Vaxneuvance was comparable to the already approved 13-valent pneumococcal conjugate vaccine (PCV13). Moreover, 30 days after the third dose, based on serotype-specific response rates, the immunogenicity of Vaxneuvance met non-inferiority criteria for the 13 pneumococcal serotypes shared by both vaccines.

These studies support the potential use of Vaxneuvance across various clinical settings, including vaccination of infants and young children, as well as special populations at increased risk of pneumococcal disease, such as children with HIV infection or sickle cell anemia.

References:

[1] U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Merck’s Vaxneuvance™ (Pneumococcal 15-valent Conjugate Vaccine) for Use in Infants and Children. Retrieved December 1, 2021, from https://www.businesswire.com/news/home/20211201005091/en

(Original text has been abridged)

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