Fall 2011 - Innovation

FDA Approves Menactra for Infants from 9 Months

Menactra, a vaccine for the prevention of invasive meningococcal disease for children ages 9 months and older has been approved by the U.S. Food and Drug Administration. The vaccine had previously been approved for patients ages 2 through 55. The approval for the younger age comes after one Phase II and three Phase III modified single-blind, controlled, multicenter clinical trialsinvolving more than 3,700 patients that included safety data for children as young as 9 months. Among babies ages 9 to 12 months, the most commonly reported adverse events included irritability and tenderness at the injection site. And, the likelihood of fever was similar to that found among other pediatric vaccines.

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.