FDA Accepts Pneumococcal 15-Valent Conjugate Vaccine for Infants, Children for Priority Review


Serotypes 22F, 33F, and 3 represent more than a quarter of invasive pneumococcal disease in children under the age of 5

Officials with the FDA have 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.

Invasive pneumococcal disease can cause serious and potentially life-threatening infections in infants and children. According to the press release, children under 2 years of age 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, some of which continue to put children at risk, including serotypes 22F, 33F, and 3. These 3 serotypes represent more than one-quarter of invasive pneumococcal disease in children under 5 years of age, according to a Merck press release.

Vaxneuvance 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 into the CFM197 carrier protein. It is indicated for active immunization of adults 18 years of age and older for the prevention of invasive disease caused by the serotypes contained in the vaccine.

“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 Roy Baynes, MD, PhD, senior vice president, head of global clinical development, and chief medical officer at Merck Research Laboratories, in the press release.

The application is supported by results from phase 2 and phase 3 clinical studies in pediatric populations, including infants, children, and adolescents. Findings from these studies support the potential use of Vaxneuvance in a variety of clinical settings, including for the 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 FDA 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.

“We look forward to working with the US FDA as it reviews what would be the first new option in pediatric pneumococcal vaccination in over a decade,” Baynes said in the press release.


US FDA Accepts for Priority Review the Supplemental Biologics License Application for Merck’s Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for Use in Infants and Children. News release. Merck; December 1, 2021. Accessed December 13, 2021. https://www.merck.com/news/u-s-fda-accepts-for-priority-review-the-supplemental-biologics-license-application-for-mercks-vaxneuvance-pneumococcal-15-valent-conjugate-vaccine-for-use-in-infants-and-children/

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