FDA approves Hiberix vaccine for Hib

August 21, 2009

FDA has approved a new Haemophilus influenza type b conjugate vaccine as a booster dose for children between 15 months and four years of age.

The Food and Drug Administration (FDA) has approved a new Haemophilus influenza type b conjugate vaccine as a booster dose for children between 15 months and four years of age.

The new vaccine, called Hiberix, is made by GlaxoSmithKline. It received accelerated-approval status from FDA due to the Hib vaccine’s unusual status. In December 2007 two of the four available Hib vaccines has lots recalled, creating a shortage. The Centers for Disease Control and Prevention deferred recommending a second booster dose of Hib vaccine, so that remaining vials could be used on the unvaccinated, as opposed to the undervaccinated.

The booster recommendation is back in play, as of June 25, 2009. The current supply still isn’t enough to catch up all children, present and past, with a booster, so FDA helped fast-track Hiberix to fill the void. Hiberix is already approved in almost 100 countries.