The FDA has granted accelerated approval of Hiberix (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate], from GlaxoSmithKline) for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b (Hib). Hiberix is approved for use in children 15 months through 4 years of age (prior to fifth birthday). Safety and efficacy data demonstrated that a booster dose of Hiberix following primary series vaccination provided protective levels of antibodies against Hib bacteria, regardless of the priming vaccine that was used.
The review of Hiberix for the booster indication was conducted under accelerated approval regulations due to the shortage of Hib vaccine supply in the U.S. Hiberix is expected to be available within several weeks.
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