FDA approves 15-valent pneumococcal vaccine for children
Merck announced Wednesday that the FDA approved an expanded indication for Vaxneuvance, the company’s 15-valent pneumococcal conjugate vaccine, to include its use in infants and children aged 6 weeks to 17 years.
The vaccine, formerly known as V114, was approved by the FDA last 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.
Steven Shapiro, DO, chairman of the department of pediatrics at Jefferson Abington Hospital in Rydal, Pennsylvania, and investigator for Merck’s PNEU-PED trial, described the vaccine’s importance in a press release.
“Despite decreases in incidence of invasive pneumococcal disease in children, certain key serotypes continue to cause serious illness that can lead to death in children under the age of 5, with serotypes 3, 22F and 33F responsible for more than a quarter of all invasive pneumococcal disease cases in this population,” Shapiro said. “With the robust clinical data supporting Vaxneuvance and this FDA approval, Vaxneuvance will be an important new option to help advance protection for children.”
Merck said the FDA’s approval was based on data from seven randomized, double-blind clinical studies assessing the safety, tolerability and immunogenicity of Vaxneuvance among infants, children and adolescents. Clinical data showed that immune responses elicited by Vaxneuvance following a four-dose pediatric series were “noninferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes based on serotype-specific immunoglobulin G geometric mean concentrations.”
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 PCV13 for 13 shared serotypes.
Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, said in a statement that the goal is to expand vaccine coverage against disease-causing serotypes.
“With this approval, we bring forward our first pediatric pneumococcal conjugate vaccine — and the first pediatric pneumococcal conjugate vaccine to be approved in almost a decade — building on our commitment to preventing invasive pneumococcal disease and on our legacy in pediatric vaccine development,” Barr said in the press release. “We thank the investigators and the families of our clinical trial participants for participating in the research studies and the role they played in this milestone.”