August 20, 2009
FDA approves Hiberix flu vaccine for kids
The U.S. Food and Drug Administration says it has approved the influenza vaccine Hiberix as a booster dose for children ages 15 months through 4 years.
The action involving Hiberix, a Haemophilus influenzae Type b vaccine, came following a nationwide shortage of Hib vaccines due to the recall and production suspension of two of four vaccines licensed in the United States for primary and booster Hib immunization.
Although current vaccine supply is sufficient to begin catch-up vaccinations, the FDA said it is not yet ample enough to support mass vaccination of all children whose boosters were deferred.
The FDA approved Hiberix under the agency's accelerated approval pathway, said Dr. Karen Midthun, 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.
Before the availability of Hib vaccines, the disease was the leading cause of bacterial meningitis among children under 5 years old in the United States. Hib disease can also cause pneumonia, severe swelling in the throat, infections of the blood, joints, bones and tissue covering of the heart, as well as death, the federal agency said.
Hiberix is manufactured by GlaxoSmithKline.