FDA grants approval to sanofi- aventis for Menactra meningococcal conjugate vaccine use in infants

Consisting of 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

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SWIFTWATER, Pa.—The U.S. operations of Sanofi Pasteur, the vaccines division of French pharmaceutical company sanofi-aventis, have announced that the U.S. Food and Drug Administration (FDA) has granted licensure to expand the indication for its meningococcal conjugate vaccine, Menactra, to include a two-dose schedule for infants and children 9 months through 23 months of age.

"The highest rate of meningococcal disease occurs in children under one year of age," said Dr. Karen Midthun, director of FDA's Center for Biologics Evaluation and Research, the day the FDA approval was announced. "With today's approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease."

Sanofi Pasteur points out that this is the first U.S. approval of a meningococcal vaccine for this age group, and adds that meningococcal disease—a rare but deadly disease caused by the bacterium Neisseria meningitides—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 alone since 2005, Sanofi Pasteur notes.

"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," says Dr. Stephen I. Pelton, professor of pediatrics and epidemiology at Boston University in the schools of medicine and public health and chief of the pediatric infectious diseases section at Boston Medical Center.

As Dr. Vincent Iannelli noted on About.com's Pediatric section in 2005 after Menactra's U.S. approval, although there has been a meningococcal vaccine available since the 1970s called Menomune, it proved unpopular because its protection did not last very long. He added in his online article that "About 48 percent of cases among infants are vaccine preventable though, so hopefully Menactra will eventually be found to be safe and effective for younger children too."

Well, he and others got that wish this month, and the FDA based that approval for infants on the strength of 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.

According to Sanofi Pasteur, results from these studies showed that two doses of Menactra vaccine given three 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," says Dr. Michael Decker, vice president of 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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