The US Food and Drug Administration (FDA) has granted approval for Merck’s (MSD outside the US and Canada) pneumococcal 15-valent conjugate vaccine, Vaxneuvance, for use in children aged six weeks to 17 years.
The vaccine is intended for active immunisation to prevent invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in people aged six weeks and above.
It is the first pneumococcal conjugate vaccine to obtain approval in nearly ten years for invasive pneumococcal disease in paediatric populations.
The latest approval for expanded indication to include use in children comes after the regulatory agency granted priority review for the supplemental application submitted by the company.
It was based on findings from seven double-blind, randomised, clinical trials that evaluated the safety, tolerability and immunogenicity of the vaccine in infants, children and adolescents.
According to findings from a pivotal study, a four-dose paediatric regimen of Vaxneuvance induced immune responses non-inferior to the presently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes.
Another assessment found that immune responses for Vaxneuvance after a four-dose paediatric regimen were superior versus PCV13 for shared serotype 3 as well as 22F and 33F, the two serotypes that are Vaxneuvance-specific.
Merck Research Laboratories global clinical development senior vice-president, head and chief medical officer Dr Eliav Barr said: “Our goal with Vaxneuvance is to expand coverage of key invasive disease-causing serotypes and provide a strong immune response to serotypes that pose substantial risk to infants and children.
“With this approval, we bring forward our first paediatric pneumococcal conjugate vaccine – and the first paediatric pneumococcal conjugate vaccine to be approved in almost a decade – building on our commitment to preventing invasive pneumococcal disease and on our legacy in paediatric vaccine development.”