FDA Accepts Sanofi Pasteur's Application to Expand Indications of Menactra Vaccine to Infant and Toddlers
Aug 26, 2010
Swiftwater, PA – (August 26, 2010) - 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 accepted for review a supplemental Biologics License Application (sBLA) for use of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) for active immunization of infants and toddlers for the prevention of invasive meningococcal disease caused by serogroups A, C, Y, and W-135.
Menactra vaccine was the first quadrivalent conjugate vaccine licensed in the United States to help protect against meningococcal disease, a rare but serious disease that can take the life of a child within 24 hours. Menactra vaccine is currently indicated for active immunization of individuals two through 55 years of age and is designed to help offer protection against four serogroups of Neisseria meningitidis (A, C, Y, and W-135), the bacterium that causes meningococcal infection.
The filing is based on results of one Phase II and three Phase III, open-label, controlled, multicenter trials, in which more than 3600 infants and toddlers from the United States received Menactra vaccine using a 2 dose schedule at 9 months and 12 months of age. At 12 months Menactra vaccine was given concomitantly with either measles-mumps-rubella-varicella vaccine (MMRV), pneumococcal conjugate vaccine (PCV7), or Hepatitis A vaccine (HepA). Results from the clinical studies show that a dose of Menactra vaccine at 9 and 12 months of age elicits a robust immune response against the serogroups included in the vaccine. Responses to the concomitantly administered vaccines were equally robust. Vaccine related reactions were similar to those described for other infant vaccines including swelling and tenderness at the site of vaccination, 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® Vaccine
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 occur. Vaccination should be avoided by persons with known hypersensitivity (severe allergic reaction) to any ingredient of the vaccine, including latex (which is used in the vial stopper), or by any persons previously diagnosed with Guillain-Barré syndrome. Vaccination with Menactra vaccine may not protect all individuals.
For more information about Menactra vaccine, go to www.menactra.com
About Meningococcal Disease
Meningococcal disease, which includes meningitis, is a serious bacterial infection that strikes between 1,000 to 2,600 Americans each year. Approximately 10 percent of individuals who contract meningococcal disease will die. Of those who survive, up to one in five suffer permanent disabilities such as hearing loss, neurological damage and limb amputations. Meningococcal disease can be hard to recognize, especially in its early stages, because symptoms are similar to those of more common viral illnesses. Unlike more common illnesses, the disease can progress quickly and may cause death or disability in just a single day.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, please visit: www.sanofi-aventis.com
Forward Looking Statements
For further information: US Media Relations Amy Ba Tel: 570-957-0717 email@example.com www.sanofipasteur.us