Priority review of VAXNEUVANCE™ for kids 6 weeks to 17 years accepted by FDA

The US Food and Drug Admistration (FDA) has accepted a Priority Review from Merck for a supplemental Biologics License Application for the company’s pneumococcal 15-valent conjugate vaccine to prevent invasive pneumococcal disease in children aged 6 weeks to 17 years.¹ The target action date set by the FDA is April 1, 2022.

The supplemental application is buoyed by results from Phase 2/3 clinical trials in the pediatric population. The studies support using the vaccine for not only young patients, but those who are increased risk of pneumococcal disease like children with sickle cell disease. Furthermore, the data indicate that the vaccine could potentially be used in a mixed dose regimen with infants who had received an initial disease of a 13-valent vaccine as well for catch-up vaccinations for older children who were either vaccine-naïve or had either received a partial or full schedule on pneumococcal vaccines with fewer serotypes.

The serotypes covered by the vaccine include 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F, of which 3: 22F, 33F and 3 are responsible for more than 25% of all cases of invasive pneumococcal disease in children aged younger than 5 years. It is currently approved for adults aged 18 years and older.

Reference

1. Merck. 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. Published December 1, 2021. Accessed December 1, 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/