US FDA Approves New Pediatric Hexavalent Vaccine
The new vaccine, dubbed Vaxelis, is designed for to be used in children aged 6 weeks to 4 years old, to keep them from contracting diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to haemophilus influenzae type B.
The vaccine is approved for use as a 3-dose series, which consists of a 0.5 mL intramuscular injection, administered at 2, 4, and 6 months of age. This vaccine does not constitute a primary immunization series against pertussis.
It is contraindicated in children with a history of anaphylaxis to any ingredient in the vaccine, health care officials are also advised not to administer Vaxelis to anyone with a history of encephalopathy, within 7 days of a pertussis-containing vaccine, that is not attributable to another identifiable cause. The vaccine is also not to be administered to anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.
Sanofi developed Vaxelis in partnership with Merck. Sanofi and Merck are now working on the production and supply of Vaxelis aiming to make it available on the market in 2020 or later.