Spring 2013 - Safety

FDA Approves Meningitis Vaccine for Children

A new children’s vaccine from GlaxoSmithKline that targets two common causes of bacterial meningitis, which can be fatal, has been approved by the U.S. Food and Drug Administration (FDA). The vaccine, Menhibrix, is meant for children ages 6 weeks to 18 months and combines vaccines for meningococcal disease and Hib disease, both of which are common causes of the infection. The safety of Menhibrix was tested in 7,500 children in the United States, Mexico and Australia. It is given in four doses, and common side effects include pain, redness and swelling at the injection site, irritability and fever.

The FDA had rejected Menhibrix twice before in 2010 and 2011, but spokespeople for GlaxoSmithKline say the company has resolved regulators’ questions about the vaccine’s potency and efficacy.

BSTQ Staff
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