Sanofi Pasteur Announces FDA Approval of Menactra Meningococcal Conjugate Vaccine Indication for Infants
- Indication Provides New Option to Help Protect Earlier Against Meningococcal Disease -
Apr 22, 2011
SWIFTWATER, Pa., April 22, 2011 /PRNewswire/ -- 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 administered 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."
About Menactra Vaccine
Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) is the only U.S. licensed conjugate vaccine for persons age 9 months through 55 years of age for active immunization against invasive meningococcal disease caused by N. meningitidis serogroups A, C, Y and W-135.
Sanofi Pasteur is a vaccine industry leader with 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 became the first quadrivalent meningococcal conjugate vaccine available in the United States for people ages 11 through 55 years of age. Menactra vaccine was approved for use in children ages 2 through 10 years of age in 2007; and approved for use in infants as young as 9 months of age in 2011.
Side effects following administration of Menactra vaccine include: pain, redness and swelling at the injection site, as well as headache or irritability 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-Barre syndrome. Vaccination with Menactra vaccine may not protect all individuals.
For Menactra vaccine prescribing information, please contact Sanofi Pasteur US.
About Meningococcal Disease
Meningococcal disease, which includes meningitis, is a serious bacterial infection that strikes between 1,000 and 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
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provides more than one billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR one million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us
Forward Looking Statements
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SOURCE Sanofi Pasteur