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The FDA has set a PDUFA action date of April 1, 2022.
The FDA has accepted for priority review a supplemental biologics license application for Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age. The FDA set a Prescription Drug User Fee Act date of April 1, 2022.
The applications is based on results from phase 2 and phase 3 clinical studies in infants, children, and adolescents. The submission also includes data supporting the potential use of the vaccine 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.
“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,” Roy Baynes, MB BCh, Ph.D., senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said in a statement.
Vaxneuvance was approved in July 2021 for use in those 18 years of age and older for the prevention of invasive disease caused by the S. pneumoniae. Previously, the vaccine had received breakthrough therapy designation from the FDA for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks through 17 years of age.
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.