The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for Vaxneuvance™ (pneumococcal 15-valent conjugate vaccine) for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks through 17 years of age.
Vaxneuvance consists of pneumococcal polysaccharides from 15 serotypes, including serotypes 22F and 33F, which are associated with invasive pneumococcal disease. For children, Vaxneuvance is administered as a 4-dose series at 2, 4, 6 and 12 through 15 months of age (and at least 2 months after the 3rd dose).
The approval was based on data from 7 randomized, double-blind clinical studies that assessed the efficacy and safety of Vaxneuvance in infants, children, and adolescents, including those at increased risk for pneumococcal disease (eg, HIV infection or sickle cell disease).
The application also included data supporting the potential use of Vaxneuvance as a part of a mixed dosing regimen following initiation of an infant vaccination schedule with PCV13 (Prevnar 13), along with use in a catch-up setting for older children who are either pneumococcal vaccine-naïve or who previously received a partial or full regimen of a lower-valency pediatric pneumococcal conjugate vaccine.
Results from the studies showed that the immune response for Vaxneuvance after a 4-dose pediatric series was noninferior to PCV13 for all 13 shared serotypes. Moreover, Vaxneuvance showed superiority to PCV13 for shared serotype 3 and serotypes 22F and 33F at 30 days post vaccination.
“With this approval, we bring forward our first pediatric pneumococcal conjugate vaccine, and the first pediatric pneumococcal conjugate vaccine to be approved in almost a decade, building on our commitment to preventing invasive pneumococcal disease and on our legacy in pediatric vaccine development,” said Dr Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.
Vaxneuvance is supplied in single-dose prefilled syringes containing 0.5mL suspension for intramuscular injection.
- US FDA approves Merck’s Vaxneuvance™ (pneumococcal 15-valent conjugate vaccine) for the prevention of invasive pneumococcal disease in infants and children. News release. Merck. Accessed June 22, 2022. https://www.businesswire.com/news/home/20220622005359/en/U.S.-FDA-Approves-Merck%E2%80%99s-VAXNEUVANCE%E2%84%A2-Pneumococcal-15-valent-Conjugate-Vaccine-for-the-Prevention-of-Invasive-Pneumococcal-Disease-in-Infants-and-Children
- Vaxneuvance. Package insert. Merck; 2022. Accessed June 22, 2022. https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_pi.pdf