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FDA Accelerates Approval of Hib Vaccine to Help Sustain Adequate Vaccine Supply ROCKVILLE, Md -- August 20, 2009 -- The US Food and Drug Administration (FDA) has approved a Haemophilus influenzae Type b (Hib) vaccine (Hiberix), as a booster dose for children aged 15 months to 4 years. 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, 2 of 4 vaccines licensed in the United States for primary and booster immunisation against invasive disease due to Hib. This shortage resulted in a recommendation by the US 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 FDA approved [the Hib vaccine] under the agency's accelerated approval pathway," said Karen Midthun, MD, FDA's Center for Biologics Evaluation and Research, Rockville, Maryland. "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." As part of the approval, the manufacturer, GlaxoSmithKline, will conduct a post-market study in the United States to evaluate the safety and immunogenicity of primary and booster vaccination with it's approved vaccine compared with a Hib vaccine already licensed in the United States. The study is intended to confirm the clinical benefit of booster immunisation with the new Hib vaccine in accordance with the accelerated approval regulations, and to provide additional data on the vaccine for young infants. The most common side effects seen in the studies following a booster dose included pain and redness at the injection site, fever, fussiness, loss of appetite, and restlessness. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version