![]() However, the BLA was met with a Complete Response Letter (CRL) from the FDA in November 2015 requiring additional clinical evidence. Merck and Sanofi initially submitted its Biological License Application (BLA) for Vaxelis in 2014, before the two companies announced they were ending their European collaboration in vaccine development in March 2016. However, the fact that Vaxelis is fully liquid has been beneficial for marketing the product in Europe, where many of the available combination vaccines it competes against do require reconstitution. Key opinion leaders (KOLs) interviewed by GlobalData have suggested that requiring reconstitution is not a major factor in their opinion of a vaccine. ![]() Unlike its rival 6-in-1 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. Vaxelis provides protection against Hib, poliovirus, HepB, and DTaP. According to GlobalData’s primary research, the introduction of a 6-in-1 vaccine, if it receives endorsement from the US Centers for Disease Control and Prevention (CDC) as an option for routine immunisation, will help to bolster vaccination rates across the US by reducing the shot burden on infants and children-a key reason for parents’ failing to adhere to national recommendations. GlobalData believes Vaxelis’ approval 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 DTaP vaccines. In late December, Merck and Sanofi secured FDA approval for Vaxelis (diphtheria, tetanus, and acellular pertussis -inactivated poliovirus -haemophilus b -hepatitis B vaccine), making it the first 6-in-1 childhood vaccine to enter the US market.
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