U.S. regulators on Thursday approved a new children’s vaccine from GlaxoSmithKline PLC that targets two common causes of bacterial meningitis, which can be fatal.
The U.S. Food and Drug Administration said the vaccine, Menhibrix, is meant for children aged from six weeks to 18 months and targets bacteria that can cause meningitis: meningococcal and Hib bacteria.
Bacterial meningitis is a serious infection of the thin lining surrounding the brain and spinal cord. It can cause severe brain damage and is fatal in 50 percent of cases if untreated.
The FDA said both types of diseases can progress rapidly in children who are not vaccinated, causing death or serious long-term health effects such as blindness, mental retardation or amputations. But early symptoms can be hard to tell apart from other illnesses common in children.
Dr. Karen Midthun, director of the FDA’s center for biologics, said Menhibrix is the first meningococcal vaccine that can be given to children as young as six weeks.
The vaccine’s safety was tested in 7,500 children in the United States, Mexico and Australia. The vaccine is given in four doses, and common side effects included pain, redness and swelling at the injection site, irritability and fever.