Sanofi, Merck’s Vaxelis is first six-in-one vaccine in US

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Sanofi and Merck & Co picked up late 2018 approval from the FDA during the holiday period, getting a green light for their six-in-one paediatric shot Vaxelis.

The US regulator approved Vaxelis for use in children from six weeks to four years of age to protect against diphtheria, tetanus and pertussis (DTP) as well as polio, hepatitis B virus and invasive disease caused by Haemophilus influenzae type B (Hib) over the holiday period, some years after six-in-one shots were made available in Europe and other parts of the world.

The new vaccine has a fully liquid formulation which means it doesn’t require reconstitution prior to dosing, and cuts down the number of injections needed by children within paediatric vaccination schedules, with just three doses given at two, four, and six months of age needed for protection against six of the 14 diseases included in the recommended vaccination schedule for US children.

The earliest Vaxelis will be available for use in the US will be 2020, according to Sanofi, which said it was working with partner Merck/MSD to “allow for a sustainable supply to meet anticipated US demand.” The product stems from a vaccines joint venture between the two companies that was dissolved a couple of years ago after more than two decades.

Sanofi Pasteur manufactures the DTP antigens used in the vaccine while Merck/MSD provides the Hib and HBV antigens. FDA approval comes almost three years after Vaxelis was registered in the EU, and two years after it was launched onto the market there.

The new vaccine provides an alternative to the current five-in-one shots approved for use in the US, made by Sanofi Pasteur and GlaxoSmithKline, that are intended to reduce the number of injections that must be given to children during immunisation programmes. Sanofi’s Pentacel covers DTP, polio and Hib, while GSK’s Pediarix provides protection against DTP, polio and HBV.

Vaxelis’ efficacy and safety were evaluated in six clinical studies, in which a total of 5,251 infants from 43 to 99 days of age at enrolment received at least one dose of Vaxelis. The three-dose regimen for Vaxelis does however not give primary immunisation against pertussis, and one additional dose of the pertussis-containing vaccine is needed to complete the immunisation series for that disease.

Sanofi and Merck filed a Biologics License Application (BLA) with the US FDA in August 2014, but in November 2015 received a Complete Response Letter (CRL) from the agency seeking additional information that delayed the regulatory verdict.