FDA Priority Review for BLA for Merck’s VAXNEUVANCE for Use in Infants and Children

Merck announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental Biologics License Application (sBLA) for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age. The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action date, of April 1, 2022.

“VAXNEUVANCE has the potential to provide meaningful protection against invasive pneumococcal disease for children and infants by targeting pneumococcal strains, or serotypes, that contribute to substantial disease burden, including serotype 3, and broadening coverage to additional disease-causing serotypes, 22F and 33F, which are not included in the pneumococcal conjugate vaccine (PCV) currently available for this population,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We look forward to working with the U.S. FDA as it reviews what would be the first new option in pediatric pneumococcal vaccination in over a decade.”

The sBLA is supported by results from Phase 2 and Phase 3 clinical studies in pediatric populations including infants, children, and adolescents. These studies support the potential use of VAXNEUVANCE in a variety of clinical settings, including immunization of infants and toddlers as well as of special populations at increased risk for pneumococcal disease, such as children with HIV infection or sickle cell disease. The submission also includes data supporting the potential use of VAXNEUVANCE as part of a mixed dosing regimen following initiation of an infant vaccination schedule with PCV13 as well as 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 PCV.

Invasive pneumococcal disease can cause serious and potentially life-threatening infections in infants and children. Children under the age of 2 are particularly vulnerable to pneumococcal infection, and incidence of invasive pneumococcal disease remains highest in the first year of life. There are 100 different types of pneumococcal bacteria, of which some continue to put children at risk, including serotypes 22F, 33F and 3, which represent more than a quarter of invasive pneumococcal disease in children under the age of 5.