August 26, 2009
On August 19, 2009, the U.S. Food and Drug Administration (FDA) approved Hiberix, a Haemophilus influenzae Type b (Hib) vaccine, as a booster dose for children 15 months through 4 years old. Hiberix is manufactured by GlaxoSmithKline, with U.S. headquarters in Research Triangle Park, NC and Philadelphia, PA.

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 United States for primary and booster immunization against invasive disease due to Hib. Both PedvaxHIB and COMVAX vaccines are manufactured by Merck & Co. Inc. (Whitehouse Station, NJ).

This shortage resulted in a recommendation by the U.S. Centers for Disease Control and Prevention (CDC) 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.

Although current vaccine supply is sufficient to reinstate the booster dose and begin catch-up vaccination, it is not yet ample enough to support mass vaccination of all children whose boosters were deferred.

The entire article can be viewed on the FDA's Web site.