Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) approved use of Menactra® [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] for booster vaccination against meningococcal disease in persons 15 years through 55 years of age.
Meningococcal disease, which includes meningococcal meningitis, is a serious bacterial infection that strikes approximately 800 to 1,200 Americans each year. Although rare, it can result in severe, permanent disabilities and death. Of those who survive, up to one in five are left with serious medical problems, which include amputation of arms, legs, fingers, or toes; neurologic damage; and deafness.
The Centers for Disease Control and Prevention (CDC) recommends routine administration of meningococcal conjugate vaccine to adolescents aged 11 through 18 years. Specifically, the CDC recommends persons receive one dose of vaccine at age 11 or 12 years, followed by a second (i.e. booster) vaccination at age 16 years, to help protect teens and young adults during the period when they are at increased risk of contracting meningococcal disease. It is important that health care providers and parents be aware of the need for a booster dose, as current data suggest that vaccine protection wanes in most teens within five years after the primary vaccination.
Despite these recommendations, results from CDC's recently published 2013 National Immunization Survey-Teen (NIS-Teen) showed that the second-dose completion rate for meningococcal conjugate vaccine was only an estimated 29.6 percent among 17-year-olds, compared to a single-dose completion rate of 77.8 percent among 13-through 17-year-olds.
"The FDA's approval of the Menactra booster vaccination gives health care providers the option to use a meningococcal conjugate vaccine that is approved for both primary and booster immunization, which aligns with the CDC's recommendations for preventing cases of meningococcal meningitis," said David P. Greenberg, M.D., Vice President, U.S. Scientific and Medical Affairs, Sanofi Pasteur. "With this approval, we hope health care providers are reminded to talk to their teen patients and their parents about the CDC's recommendations, ultimately helping to improve booster immunization rates for teens across the country."
Teens are at an increased risk of meningococcal disease due to common everyday activities such as kissing, sharing utensils and water bottles and living in close quarters, such as a college dormitory.
This FDA approval of Menactra was based on results of an open-label trial that evaluated the safety and immunogenicity of a booster dose of Menactra vaccine among persons who received Menactra vaccine 4 to 6 years earlier. The most common adverse events reported after the booster dose were injection-site pain and myalgia. Overall rates of solicited injection-site reactions and solicited systemic reactions were similar to those observed in adolescents and adults after a single dose of Menactra vaccine.
Menactra vaccine was approved by the FDA in January 2005, making it 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).
For persons for whom a primary vaccination is recommended, Menactra vaccine should be given as a 2-dose series, administered 3 months apart, for children 9 months through 23 months of age and as a single dose for persons 2 years through 55 years of age.
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