FDA accelerated approval of GSK's Hiberix to help sustain adequate vaccine supply

In response to shortage, the US Food and Drug Administration approved UK drug giant GlaxoSmithKline's Hiberix, a Haemophilus influenzae Type b (Hib) vaccine, as a booster dose for children 15 months through four years old.

A nationwide shortage of Hib vaccine began in December 2007 due to a voluntary recall by the manufacturer and subsequent production suspension of PedvaxHIB and COMVAX, two of four vaccines licensed in the USA for primary and booster immunization against invasive disease due to Hib. Both PedvaxHIB and COMVAX vaccines are manufactured by US dug major Merck & Co.

This shortage resulted in a recommendation by the US Centers for Disease Control and Prevention to temporarily defer the Hib vaccine booster dose for children who were not at high risk for infection, until the vaccine supply could be restored. This deferral was in effect from December 18, 2007, through June 25, 2009.