FDA Approves GlaxoSmithKline's Menhibrix Vaccine

   By Jennifer Corbett Dooren 
 

WASHINGTON--The U.S. Food and Drug Administration approved a new combination vaccine Thursday made by GlaxoSmithKline PLC (GSK, GSK.LN), designed to protect young children against bacterial meningitis and other illnesses.

The vaccine, Menhibrix, is specifically designed to protect against illnesses caused by the bacteria Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b.

Diseases caused by the bacteria can infect the bloodstream, causing sepsis, and the lining that surrounds the brain and spinal cord, causing meningitis, which can be fatal.

The FDA said the vaccine is the first meningococcal vaccine that can be given to children starting as young as six weeks of age.

Menhibrix will be given as a four-dose series to babies at 2, 4, 6 and 12 through 15 months of age, which is the same time schedule that other children's vaccines are usually administered. The first dose may be given as early as 6 weeks of age, while the fourth dose may be given as late as 18 months of age, FDA said.

-By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294; jennifer.corbett@dowjones.com

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(END) Dow Jones Newswires

June 14, 2012 17:21 ET (21:21 GMT)

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