FDA Approves Merck’s Vaxneuvance for Expanded Use in Children Aged 6 Weeks to 17 Years to Prevent Invasive Pneumococcal Disease

Today, MSD announced that the U.S. FDA has approved the expanded use of its 15-valent pneumococcal conjugate vaccine Vaxneuvance for the prevention of invasive diseases caused by pneumococcal infection in children aged 6 weeks to 17 years. The press release noted that Vaxneuvance is the first new pneumococcal conjugate vaccine approved by the FDA in nearly a decade to prevent invasive pneumococcal disease (IPD) in the pediatric population.

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 the prevention of invasive diseases caused by the pneumococcal serotypes contained in the vaccine in adults aged 18 years and older. 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. Its supplemental Biologics License Application also received Priority Review designation from the FDA.

FDA Approval Based on Seven Randomized, Double-Blind Clinical Trials in Infants, Children, and AdolescentsData from pivotal clinical trials show that the immune response elicited by four doses of Vaxneuvance met non-inferiority criteria for immunogenicity compared to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 pneumococcal serotypes shared by both vaccines.

In a secondary analysis, Vaxneuvance demonstrated superior immune responses against serotype 3 (shared with PCV13), as well as 22F and 33F (unique to Vaxneuvance), compared to PCV13.

Data from clinical development programs also show that Vaxneuvance can be co-administered with other commonly used pediatric vaccines and can replace PCV13. The studies further support the potential use of Vaxneuvance across various clinical settings, including immunization of special populations at increased risk for pneumococcal disease, such as children with HIV infection or sickle cell anemia.

"Although the risk of invasive pneumococcal disease in children has decreased, certain key serotypes continue to cause severe illness and even death in children under 5. Serotypes 3, 22F, and 33F account for approximately 25% of invasive diseases in this population," said Dr. Steven Shapiro from Jefferson Abington Hospital, one of the clinical trial investigators. "The clinical trial data of Vaxneuvance and its approval by the FDA provide an important new option for protecting these children."

References:

[1] U.S. FDA Approves Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Infants and Children. Retrieved June 22, 2022, from https://www.businesswire.com/news/home/20220622005359/en

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