Merck sBLA for Pneumococcal Vaccine

FDA has accepted for review a Merck supplemental BLA for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for preventing invasive pneumococcal disease in children six weeks through 17 years of age. The agency has set a user fee review action target date of 4/1/2022.

“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,” the company says.

The submission is based on data from Phase 2 and Phase 3 clinical studies in pediatric populations including infants, children, and adolescents. The vaccine previously received a breakthrough therapy designation from the agency.