Aventis, part of the sanofi-aventis Group, announced that the Vaccines and Related Biological Products Advisory Committee of the US FDA has recommend licensure of Menactra (Meningococcal 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, 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, vice president, scientific and medical affairs at Aventis Pasteur, the human vaccines business of Aventis, part of the sanofi-aventis Group. He added, "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.
Aventis Pasteur is currently constructing a new, state-of-the-art production facility at its US site in Swiftwater, Pennsylvania, to produce Menactra meningococcal vaccine. The new facility is intended to ensure Aventis Pasteur's ability to meet anticipated global demand for the product.
Meningococcal disease is a rare but devastating bacterial infection that causing meningitis or sepsis in the majority of cases. Approximately 10 percent of individuals who contract meningococcal disease will die. Of survivors, up to one in five suffer long-term permanent disabilities such as hearing loss, brain damage and limb amputations.
The current FDA-licensed meningococcal disease vaccine, Menomune-A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined), is made from a long chain of polysaccharides that come from the outer coat of the meningococcus bacterium, providing a limited duration of immunity. Duration of protection against meningococcal disease with Menomune-A/C/Y/W-135 vaccine is approximately three to five years.