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Aug 20, 2009

GSK Wins Accelerated Approval of Hib Vaccine to Help Sustain Supply

  • FDA has given GlaxoSmithKline’s haemophilus influenzae Type b (Hib) vaccine, Hiberix, the go-ahead. It can be used as a booster dose for children 15 months through four years.

    A nationwide shortage of Hib vaccine began in December 2007 due to a voluntary recall by Merck & Co. and subsequent production suspension of PedvaxHIB and Comvax, two of four vaccines licensed in the U.S. for primary and booster immunization against invasive disease due to Hib, according to the agency.

    CDC subsequently recommended that children who were not at high risk for infection should stop receiving the Hib vaccine booster dose until the vaccine supply could be restored. This deferral was in effect from Dec. 18, 2007, through June 25, 2009. Although the current vaccine supply is sufficient to reinstate the booster dose and begin catch-up vaccination, it is not yet enough to support mass vaccination of all children whose boosters were deferred, FDA reports.

    “The FDA approved Hiberix under the agency’s accelerated approval pathway,” says Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “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.”

    Hiberix is used in nearly 100 countries. The FDA based its conclusion that it is safe and effective on data from seven clinical studies conducted in Europe, Latin America, and Canada that involved more than 1,000 children.

    As part of the approval, GlaxoSmithKline, will conduct a postmarket study in the U.S. to evaluate the safety and immunogenicity of primary and booster vaccination with Hiberix compared to a Hib vaccine already licensed in the country. The study is intended to confirm the clinical benefit of booster immunization with Hiberix and to provide additional data related to its use in infants.

     



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