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Local Tech Wire
RESEARCH TRIANGLE PARK, N.C. – The U.S. Food and Drug Administration has granted accelerated approval to GlaxoSmithKline (NYSE: GSK) for its vaccine Hiberix.
The booster vaccine is for children ages 15 months to four years and is designed to combat Hib (bacterial infection Haemophilus influenzae type b) that can cause meningitis.
The FDA granted accelerated approval since there is a shortage of vaccines to fight Hib.
“The FDA approved Hiberix under the agency’s accelerated approval pathway,” said Karen Midthun, acting director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “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.”
According to the FDA, before the availability of vaccines, Hib disease was the leading cause of bacterial meningitis among children under five.
A shortage has existed since Merck temporarily stopped production of its two products in 2007 for a voluntary recall.
GSK plans to make the vaccine available in several weeks. Hiberix is already used in nearly 100 countries.
“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 said in a statement.
GSK maintains its U.S. headquarters in RTP and employs some 5,000 people in the Triangle area.