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.

"We are pleased that we were able to respond to this public health need," said Peter Lammers, vice president, US Vaccines, GlaxoSmithKline. "GSK was able to act swiftly to increase supply of Hib vaccine so that children can complete the vaccination schedule as recommended by the CDC."

The CDC recommends that children receive the complete Hib vaccination series. The series includes a booster dose in the second year of life, in addition to a complete primary series of immunization in infants.

"It is important for children to complete the series of recommended immunizations, including booster shots, to protect them against serious infectious diseases such as Hib," said Jerome Klein, professor of Paediatrics at Boston University School of Medicine, member of the Division of Paediatric Infectious Diseases at Boston Medical Center. "The approval and availability of an additional Hib vaccine, for the booster dose will make it possible for children to be fully immunized to prevent serious infectious diseases caused by Hib."

The review of Hiberix for the booster indication was conducted under accelerated approval regulations due to the shortage of Hib vaccine supply in the US. GSK submitted safety and efficacy information from clinical studies conducted outside the US. for this review. In those studies, 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.

More than 54 million doses of Hiberix have been distributed outside the US since the 1996 launch in Germany, and the vaccine is currently registered in nearly 100 countries.

The vaccine is expected to be available within several weeks.

Hiberix is indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b.