US regulators have approved GlaxoSmithKline's Hiberix vaccine for children to prevent disease caused by Haemophilus influenzae type b.

The company announced that in response to a US shortage of a vaccine to protect infants from Hib, “an often severe and potentially deadly bacterial infection that can cause meningitis,” it has received accelerated approval from the US Food and Drug Administration for Hiberix as a booster dose in children 15 months through four years of age. The vaccine is expected to be available "within several weeks”.

GSK noted that the Hib vaccine shortage began in December 2007 when Merck & Co temporarily suspended manufacturing of its PedvaxHIB and ComVax vaccines. This led the US Centers for Disease Control and Prevention (CDC) 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, though this 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”. The FDA confirmed that although current supply is sufficient to reinstate the booster dose and begin the catch-up effort, “it is not yet ample enough to support mass vaccination of all children whose boosters were deferred.”

Peter Lammers, vice president of US Vaccines at GSK, says the firm was able to act swiftly to increase supply of Hib vaccine so that children can complete the vaccination schedule as recommended by the CDC.