SWIFTWATER, Pa. -- Aventis, part of the sanofi-aventis Group, announced today that the Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously to recommend licensure of Menactra(TM) (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate) vaccine for protection against invasive meningococcal disease in adolescents and adults aged 11-55 years.
Menactra vaccine is the first quadrivalent conjugate meningococcal vaccine for the prevention of meningococcal disease, a serious bacterial infection that can cause meningitis and sepsis (blood infection). This vaccine is designed to offer protection against four of the most common serogroups (A, C, Y, W-135) that cause meningococcal disease.
"Meningococcal meningitis is a potentially deadly infectious disease which affects children, adolescents and young adults in the United States and we are very pleased with the positive response from the FDA's Advisory Committee regarding our conjugate vaccine candidate, Menactra, that has the potential for substantial control of this serious disease," said Michael Decker, MD, MPH, vice president, scientific and medical affairs at Aventis Pasteur, the human vaccines business of Aventis, part of the sanofi-aventis Group. "Conjugate vaccines have been shown to induce a better and longer-lasting immune response than polysaccharide vaccines, and we believe that Menactra vaccine will offer these benefits to our nation's adolescents and young adults."
Although the FDA is not bound by the Advisory Committee's recommendation, the agency considers it carefully when deciding whether to license a vaccine for marketing.
In making its recommendation, the FDA Advisory Committee reviewed safety and immunogenicity data from six pivotal studies. The vaccine was shown to be immunogenic, safe and well-tolerated.
Aventis Pasteur is currently constructing a new, state-of-the-art production facility at its
"Aventis Pasteur is committed to satisfying all FDA requirements for vaccine licensure and, if licensed by the FDA, we intend to have the vaccine available as quickly as possible," said Dr. Decker.
Impact of Conjugate Meningococcal Vaccine in the
Experience in the
Disease rates also declined 60 percent among unvaccinated children. This "herd immunity" effect is a result of the conjugate vaccine's ability to prevent carriage of the bacteria in the nose and throat and, thus, transmission of the bacteria to other persons. Carriage rates in children 15 to 17 years old decreased by 66 percent.
Obtaining similar public health benefits in the
Source: Aventis Pasteur; sanofi-aventis Group