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pharmiweb.com today | 21 January 2019

Sanofi and Merck’s six-in-one vaccine Vaxelis can reduce shot burden on infants and children in US, says GlobalData

The US Food and Drug Administration (FDA) recently approved pharma giants Sanofi and Merck's Vaxelis, a new pediatric vaccine against six diseases. The vaccine will help to bolster vaccination rates across the US by reducing the shot burden on infants and children, according to GlobalData, a leading data and analytics company. 

Vaxelis, which is indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenzae type b, was developed as part of a joint-partnership between Sanofi and Merck, known as MSD outside the US and Canada....

James Mather, Pharma Analyst at GlobalData, says: “Vaxelis’ approval in the US is a major regulatory breakthrough, as the FDA has been more hesitant than the European Medicines Agency (EMA), which approved Vaxelis in 2015, in the acceptance of high-valiancy diphtheria, tetanus, and acellular pertussis (DTaP) vaccines.”

Unlike its rival six-in-one vaccine in Europe, GlaxoSmithKline’s (GSK’s) Infanrix Hexa (DTaP-IPV-HepB/Hib), Vaxelis is fully liquid and therefore does not require reconstitution, providing a more convenient route of administration for physicians and their office staff.

Mather adds: “The US childhood immunization recommendations consist of a crowded schedule. Without combination vaccines, this would mean that infants would require as many as 24 shots by the time they are two years of age. Combination vaccines, which can provide comparable efficacy to their component vaccines, will drastically reduce the number of vaccines that children receive.”

The approval of Vaxelis in the US is likely to heat up competition between Merck, Sanofi, and GSK in the childhood routine vaccine space that they currently dominate. However, it may still be some time before the hexavalent vaccine reaches the market, as Merck and Sanofi are ramping up production to allow for a sustainable supply of vaccines to be available in the US after 2019.

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