Issue: May 2011
May 01, 2011
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FDA approves meningococcal vaccine for infants as young as 9 months

Issue: May 2011

The FDA has approved a vaccine for the prevention of invasive meningococcal disease caused by certain serogroups of Neisseria meningitidis for use in children, according to a press release from the FDA.

Menactra (Sanofi Pasteur) was approved to prevent N. meningitidis serogroups A, C, Y and W-135. The approval is for a two-dose series beginning at aged 9 months. Doses should be administered three months apart.

The approval came on the heels of results from four trials involving more than 3,700 participants as young as 9 months. Injection-site tenderness and irritability were reported, and fever rates were comparable to other vaccines.

The vaccine is currently approved for use in individuals aged 2 to 55 years.

For more information please visit the FDA website.

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