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FDA Accepts Sanofi Pasteur's Application to Expand Indication of Menactra® Vaccine to Infants and Toddlers
Date:8/26/2010

cination, as well as irritability.  Most of these side effects were mild and of short duration.

"Sanofi Pasteur is committed to evaluating Menactra vaccine in different age groups in an effort to provide the broadest protection against meningococcal disease," said Michael Decker, MD, MPH, vice president, scientific and medical affairs at sanofi pasteur. "Sanofi Pasteur's meningococcal vaccination approach, focusing on later infancy and the early second year of life, will require only half the doses of an early infant toddler strategy."

About Menactra® VaccineMenactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) is the only U.S. licensed conjugate vaccine for persons two through 55 years of age for active immunization against invasive meningococcal disease caused by N meningitidis serogroups A, C, Y, and W-135.  Since 2005 when it was first licensed in the U.S., more than 32 million doses of Menactra vaccine have been distributed.

A vaccine industry leader, Sanofi Pasteur has a strong heritage of meningococcal vaccine development.  Meningococcal vaccines designed to help protect against serogroups A and C were introduced in the mid-1970s.  In 1981, Menomune®-A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined) became the first meningococcal vaccine available to help protect against meningococcal disease caused by four of the five most common serogroups (A, C, Y and W-135).

In 2005, Menactra vaccine was granted FDA licensure and became the first quadrivalent meningococcal conjugate vaccine available in the U.S. for those 11-55 years of age.  Two years later the age indication was extended down to the age of two years.

Side effects following administration of Menactra vaccine include: pain, redness, and swelling at the injection site, as well as headache and fatigue.  Other side effects may
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