FDA approves new indication for Hib vaccine

January 17, 2016

FDA has approved an expanded age indication for Hib vaccine (Hiberix, GlaxoSmithKine).

FDA has approved expanded age indication for Hib vaccine (Hiberix, GlaxoSmithKine).

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Haemophilus influenzae type b (Hib) infection is a serious disease caused by bacteria usually affecting children under the age of five. The bacteria are spread person-to-person and if they reach the lungs or the bloodstream, then the bacteria become invasive and can cause serious problems such as bacterial meningitis. Hib disease can also cause pneumonia, severe swelling in the throat, infections of the blood, joints, bones, as well as death. Due to the serious consequences of this infection, Hib vaccination for appropriate children is routinely recommended.

The Centers for Disease Control and Preventio n schedule for Hib vaccination recommends a first dose at aged 2 months of age, second dose at aged 4 months, third dose at aged 6 months (if needed, depending on type of vaccine), and a final booster dose at aged 12 to 15 months of age. 

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Hiberix is a Haemophilus b conjugate vaccine indicated to provide active immunization for the prevention of invasive disease caused by Hib. Hiberix originally received accelerated approval by FDA in 2009 as a booster dose for children aged 15 months through 4 years because of a nationwide shortage of Hib vaccines on the market. With the new expanded age indication, Hiberix is now indicated for the immunization of children aged 6 weeks through 4 years (prior to fith birthday) for the same indication.  

“Hib is a serious, invasive bacterial disease that is preventable by vaccination,” said Dr. Leonard Friedland, vice president/director, scientific affairs & public health, GSK Vaccines, North America. “HIbernix provides another Hib option to healthcare providers and patients to receive protection against a serious childhood infectious disease.”

FDA’s approval was based on the evaluation of effectiveness of the drug on immune responses in children using serological endpoints that predict protection from disease because of Hib. Side effects associated with Hiberix include pain and redness at the injection site, irritability, drowsiness, fever, and loss of appetite. 

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