FDA approval of Vaxneuvance vaccine for use in children

FDA approval of Vaxneuvance vaccine for use in children


Vaxneuvance vaccine

The Vaxneuvance, a 15-valent pneumococcal conjugate vaccine, produced my Merck & Co. received approval by the US Food and Drug Administration (FDA) for its use in children aged six weeks through to 17 years, making it the first pneumococcal conjugate vaccine approved in almost a decade to help protect paediatric populations against invasive pneumococcal disease. 

Last year, the FDA cleared Vaxneuvance 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 adults. This vaccine is also authorised in Europe but for individuals 18 years and older.  

Data from seven studies assessing Vaxneuvance in infants, children, and adolescents showed that immune responses elicited by Vaxneuvance following a four-dose paediatric series were non-inferior to Pfizer’s Prevnar 13, which is also approved in the US for adults and in children as young as six weeks old. 

This represents an improvement in health therapies for paediatric populations across the globe.  

You can find more information on this news here.  

June 27th, 2022|