The U.S. Food and Drug Administration announced approval of 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. The action “addresses a nationwide shortage in the U.S. 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, N.J.).

This shortage resulted in a recommendation by the U.S. 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 Dec. 18, 2007, through June 25, 2009.”  Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research, said, “The FDA approved Hiberix under the agency’s accelerated approval pathway. This approval will provide an additional safe and effective vaccine to help ensure that there is an adequate Hib vaccine supply during necessary catch-up vaccinations.” http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm179533.htm