GSK's Hib vaccine Hiberix gets US FDA approval

In response to a US shortage of a vaccine to protect infants from Haemophilus influenzae type b (Hib), GlaxoSmithKline (GSK) has received accelerated approval from the FDA (Food and Drug Administration) for Hiberix [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] as a booster dose in children 15 months through four years of age. Hib is an often severe and potentially deadly bacterial infection that can cause meningitis.

The Hib vaccine shortage began in 2007 when another vaccine manufacturer temporarily suspended manufacturing of its Hib containing vaccines. This led the CDC (Centers for Disease Control and Prevention) to recommend temporary deferral of the booster dose for healthy children not at increased risk for Hib disease. Earlier this summer, the CDC reinstated the routine Hib booster dose due to an increase in supply. However, supply was not sufficient to support a mass catch-up effort for the millions of children who did not receive the booster dose during the shortage. Hiberix will help restore supply so children who missed the booster dose can get caught-up. Additionally, children coming in for routine visits can receive the Hib booster shot on time.