FDA will review Merck's 15-valent pneumococcal vaccine for children

Merck announced Wednesday that the FDA has accepted for priority review a supplemental biologics license application for Vaxneuvance, the company’s 15-valent pneumococcal conjugate vaccine, for use in infants and children.

The vaccine, formerly known as V114, was approved by the FDA in July for adults. It prevents invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.

As part of the review, the vaccine’s effects will be examined in children aged 6 weeks through 17 years.

“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 currently available for this population,” Merck Chief Medical Officer Roy Baynes, MD, PhD, said in a release. “We look forward to working with the U.S. FDA as it reviews what would be the first new option in pediatric pneumococcal vaccination in over a decade.”

Merck said the application was supported by results from phase 2 and phase 3 clinical studies in pediatric populations.

“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,” it said.

The FDA’s initial approval of the vaccine for adults was based on data from seven randomized, double-blind clinical studies, which showed that the vaccine was noninferior to the 13-valent pneumococcal conjugate vaccine (PCV13) for 13 shared serotypes. Immune responses were superior to PCV13 for serotype 3 and for two serotypes unique to Vaxneuvance, 22F and 33F, Merck said.

Randomized controlled studies assessing the clinical efficacy of Vaxneuvance compared with PCV13 have not been conducted.

Reference:

Merck. Merck announces US FDA approval of Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for the prevention of invasive pneumococcal disease in adults 18 years and older caused by 15 serotypes. https://www.merck.com/news/merck-announces-u-s-fda-approval-of-vaxneuvance-pneumococcal-15-valent-conjugate-vaccine-for-the-prevention-of-invasive-pneumococcal-disease-in-adults-18-years-and-older-caused-by-15-serot/. Accessed December 1, 2021.