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FDA Approves Six-In-One Vaccine for Children

Sanofi and Merck’s six-in-one vaccine Vaxelis can reduce shot burden on infants and children in U.S.

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

Vaxelis, which is indicated for active immunisation 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 U.S. and Canada.

James Mather, pharma analyst at GlobalData said, “Vaxelis’ approval in the U.S. 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 the GlaxoSmithKline’s (GSK’s) Infanrix Hexa (DTaP-IPV-HepB/Hib) six-in-one vaccine in Europe, Vaxelis is fully liquid and therefore does not require reconstitution, providing a more convenient route of administration for physicians.

Mather added, “The U.S. childhood immunisation 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 U.S. 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 U.S. after 2019.

Mather concluded, “If it receives endorsement from the US Centers for Disease Control and Prevention (CDC) as an option for routine immunisation, it will help reduce the shot burden, a key reason for parents’ failing to adhere to national recommendations. Vaxelis is likely to garner significant patient share as the main product for the second, third and fourth DTaP doses for infants, although its uptake may take some time as it is integrated into the current immunisation schedule”. [APBN]