2 December 2021 - - The US Food and Drug Administration has accepted for Priority Review a supplemental Biologics License Application for Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age, US-based pharmaceutical company Merck (NYSE: MRK) said.

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.

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.

Vaxneuvance, US-based Merck's (NYSE: MRK) 15-valent pneumococcal conjugate vaccine, consists of purified capsular polysaccharides from S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to CRM197 carrier protein.

Vaxneuvance is indicated for active immunization of adults 18 years of age and older for the prevention of invasive disease caused by the S. pneumoniae serotypes contained in the vaccine. It is currently under investigation in the pediatric population.

Vaxneuvance previously received Breakthrough Therapy designation from the FDA for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks through 17 years of age.