Drugmaker GlaxoSmithKline PLC said Thursday it received Food and Drug Administration approval for its vaccine Hiberix, a booster shot that helps prevent a bacterial infection.
The London-based drugmaker said Hiberix was approved as a booster dose for children 15 months to 4 years old. The vaccine targets the bacterial infection Haemophilus influenzae type b, or Hib, which can cause meningitis. GlaxoSmithKline got accelerated approval for Hiberix because there was not enough of the vaccine on the market.
Supplies of the vaccine ran short in 2007 after another company stopped making its product. GlaxoSmithKline said the Centers for Disease Control and Prevention recommended that parents hold off on getting their children vaccinated if they were not at high risk for contracting Hib. The shortage ended earlier this summer and many parents have been catching their children up on the vaccine.
GlaxoSmithKline said there was not enough of the vaccine to cover that demand. It said Hiberix will be available in the next several weeks.
Hib vaccinations are given as a series of shots for infants, with a secondary boost given later, usually in the second year.
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