FDA Approves Meningitis Vaccine for Infants

iStockphoto/Thinkstock(WASHINGTON) — The U.S. Food and Drug Administration Thursday approved an infant vaccine that experts say will protect small children from two potentially fatal bacterial diseases.

Menhibrix, manufactured by the Belgium-based company GlaxoSmithKline Biologicals, is said to prevent the potentially life-threatening Haemophilus influenza type b (Hib disease) and Neisseria meningitidis (meningococcal disease) from occurring in children who are particularly susceptible when under 2 years of age. The combination vaccine is to be administered to infants in four doses beginning as early as 6 weeks of age with the last dose being given as late as 18 months of age.  

The FDA says that without the vaccination, the Hib and meningococcal diseases are especially dangerous to children because their symptoms can be difficult to detect or distinguish from other common childhood illnesses. Additionally, Hib and meningococcal disease often progress quickly and can lead to long-term health conditions such as blindness, mental retardation or amputations.  The diseases can even be fatal in some cases.

These bacteria, the FDA says, can lead to sepsis once the bloodstream becomes infected.  Meningitis follows the bacteria’s infection of the lining surrounding the brain and spinal cord.

Common side effects of Menhibrix include pain, redness and swelling at the injection site, irritability and fever, the FDA cautions.

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