Visitors entrance at Merck in Darmstadt, Germany. (Credit: Armin Kübelbeck/Wikipedia)
Merck announced that the US Food and Drug Administration (FDA) expanded the indication for Vaxneuvance, its Pneumococcal 15-valent conjugate vaccine, to include infants and children aged six weeks to 17 years.
The US agency has previously approved Vaxneuvance for active immunisation in adults in July last year.
The vaccine has also received the Breakthrough Therapy designation and Priority Review from the US FDA, for the current paediatric indication.
Vaxneuvance contains purified capsular polysaccharides from Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to CRM197 carrier protein.
It is not indicated for individuals with a severe allergic reaction to any component of Vaxneuvance or to diphtheria toxoid.
Merck Research Laboratories senior vice president, global clinical development head and chief medical officer 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.”
The FDA approval was based on data from seven randomised, double-blind clinical studies that evaluated Vaxneuvance in infants, children and adolescents.
According to the study data, the immune responses elicited after a four-dose paediatric series of Vaxneuvance showed non-inferiority to the 13-valent pneumococcal conjugate vaccine (PCV13).
In a secondary analysis, the vaccine showed superior immune responses to PCV13 for shared serotype 3 and the two unique serotypes, 22F and 33F.
In addition, the study data supported the use of Vaxneuvance in special populations, such as in preterm infants and children living with HIV infection or sickle cell disease, said Merck.