FDA approves GlaxoSmithKline's new combo vaccine MenHibrix

The US Food and Drug Administration has approved US pharma giant GlaxoSmithKline’s (LSE: GSK) MenHibrix (meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine), a combination vaccine for infants and children aged six weeks through 18 months, for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b.

The basis for FDA approval of MenHibrix included data GSK submitted from clinical trials conducted in the USA, Mexico, Australia, Belgium and Germany over seven years in which 7,521 infants and toddlers received at least one dose of MenHibrix. Of these participants, 3,349 were located in the USA. Adverse events in clinical trials included pain and redness at the injection site, irritability, drowsiness and loss of appetite.

First vaccine that can be given to infants as young as six weeks