WASHINGTON (Reuters) – U.S. regulators on Thursday approved a new infant’s vaccine from GlaxoSmithKline PLC that targets two common causes of bacterial meningitis.
The U.S. Food and Drug Administration said the vaccine, MenHibrix, is meant for children aged six weeks to 18 months and combines vaccines for meningococcal disease and Haemophilus influenzae type b (Hib).
The vaccine targets the C and Y strains of meningococcal bacteria, as well as Hib. The B, C, and Y strains cause most cases of meningococcal disease in the United States – although there is no vaccine for the B strain, Glaxo said.
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.
The FDA had rejected MenHibrix twice before, in 2010 and 2011, but GlaxoSmithKline said it had resolved regulators’ questions about the vaccine’s potency and efficacy.
About 4,100 cases of bacterial meningitis occurred in the United States each year from 2003 to 2007 – the most recent data available – and 500 people died from the disease, according to the Centers for Disease Control and Prevention. Infants are at highest risk.
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.