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FDA grants accelerated approval for Hib booster vaccine
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Hiberix, a Haemophilus influenzae type b vaccine used in nearly 100 countries, received approval for use in U.S. children aged 15 months through 4 years and is expected to help meet vaccine supply needs following the Advisory Committee on Immunization Practice’s June 25th decision to reinstate the Hib booster dose.
“The FDA approved Hiberix (GlaxoSmithKline) under the agency’s accelerated approval pathway,” Karen Midthun, MD, acting director of the FDA’s Center for Biologics Evaluation and Research said in a press release. “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.”
In December 2007, the CDC temporarily deferred the Hib vaccine booster dose for children who were not at high risk for infection when the manufacturers of two of the four Hib vaccines licensed in the United States announced that they were unable to meet production demands.
Data from seven clinical trials involving more than 1,000 children in Europe, Latin America and Canada support the safe and effective use of Hiberix as a booster dose in the United States.
GlaxoSmithKline plans to conduct additional post-marketing studies in accordance with the FDA’s accelerated approval regulations to compare the safety and immunogenicity of Hiberix with other Hib vaccines already licensed in the United States, as well as to provide additional data on Hiberix use in young infants.