Sanofi Pasteur announces FDA approval of menactra meningococcal conjugate vaccine indication for infants

April 22, 2011 - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has granted licensure to expand the indication for its meningococcal conjugate vaccine, Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), to include a two-dose schedule for infants and children 9 months through 23 months of age. This is the first U.S. approval of a meningococcal vaccine for this age group.

"Licensure of Menactra vaccine for infants as young as 9 months of age gives the opportunity to help protect infants against this potentially deadly disease when the likelihood of exposure supports a need for early protection," said Stephen I. Pelton, MD, Professor of Pediatrics and Epidemiology, Boston University Schools of Medicine and Public Health and Chief, section of Pediatric Infectious Diseases, Boston Medical Center.

Meningococcal disease is a rare but deadly disease caused by the bacterium Neisseria meningitidis. The disease can progress quickly and take the life of a child within 24 hours. Menactra vaccine was the first quadrivalent conjugate vaccine licensed in the United States for active immunization against meningococcal disease caused by the serogroups contained in the vaccine (A, C, Y and W-135). More than 36 million doses of Menactra vaccine have been distributed in the United States since its licensure in 2005.

The FDA approval of Menactra vaccine for infants was based on results of one Phase II and three Phase III modified single-blind, controlled, multicenter trials in which more than 3,300 infants from the United States received Menactra vaccine using a two-dose schedule, starting as young as 9 months of age. Results from these studies showed that 2 doses of Menactra vaccine given 3 months apart elicit a robust immune response against the serogroups included in the vaccine. The studies also showed that measles-mumps-rubella-varicella vaccine (MMRV) and pneumococcal conjugate vaccine (PCV7) can be administrated concomitantly with Menactra vaccine in children. Vaccine related reactions included swelling, tenderness at injection site, and irritability.

"The approval of Menactra vaccine for infants is a significant advancement toward potentially eliminating the threat of this serious disease in this vulnerable population for included serogroups," said Michael Decker, MD, MPH, vice president, scientific and medical affairs at Sanofi Pasteur. "With this approval, it is now possible to help protect persons from 9 months through 55 years of age."

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