Sanofi Pasteur Receives FDA Approval of Meningococcal Vaccine fo... ( Menactra(R) Meningococcal Conjugate ...)

Sanofi Pasteur Receives FDA Approval of Meningococcal Vaccine for Children

Date:10/19/2007

Menactra(R) Meningococcal Conjugate Vaccine Approved for Use in Children 2

Years Through 10 Years of Age

SWIFTWATER, Pa., Oct. 19 /PRNewswire-FirstCall/ -- Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has granted licensure to expand the indication for its meningococcal conjugate vaccine, Menactra(R) (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), to include children 2 years through 10 years of age.

Menactra(R) vaccine is the first and only quadrivalent conjugate vaccine licensed in the U.S. for the prevention of meningococcal disease. The vaccine first received FDA licensure in 2005 for immunization of adolescents and adults 11 years through 55 years of age. Menactra vaccine offers protection against four of the five most common serogroups of the bacterium that cause meningococcal infection, Neisseria meningitidis serogroups A, C, Y and W-135. No vaccine is available in the United States for protection against infection from serogroup B.

"We have been waiting for this expansion of use of Menactra(R) to younger children, since they too are at risk and may benefit from the vaccine. Meningococcal disease is serious and no healthy child should have to risk permanent disability, or even death, from this vaccine-preventable disease. About half of the cases in children 2 years through 5 years, and two-thirds in those 6 years through 11 years can potentially be prevented through vaccination in the United States" said Michael Pichichero, MD, professor of microbiology/immunology, pediatrics and medicine, University of Rochester Medical Center.

Clinical Studies

The FDA's decision to license Menactra(R) vaccine for children 2 years through 10 years of age was based on safety and immunogenicity data from two large clinical studies. Both studies were randomized, multi-center, active- controlle
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