Advisory Panel Recommends FDA Licensure of Aventis' Menactra(TM) Vaccine for Protection Against Meningococcal Disease

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 U.S. site in Swiftwater, Pa., to produce Menactra meningococcal vaccine. The new facility is intended to ensure Aventis Pasteur's ability to meet anticipated global demand for the product.

"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 United Kingdom

Experience in the United Kingdom suggests that conjugate meningococcal vaccines provide significant benefits over traditional vaccines. From 1999 to 2000, the United Kingdom ran a national campaign to immunize 15 million children under age 17 with a conjugate vaccine that offered protection against one serogroup (the C serogroup) of meningococcal bacteria, which causes a greater proportion of cases in the United Kingdom than in the United States. The campaign resulted in an 85 percent overall decline in cases and a 90 percent reduction in deaths from meningococcal serogroup C disease within one year.

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 United States would require a vaccine that protects against multiple serogroups of meningococcal bacteria. Four serogroups (C, Y, W-135 and B) predominate in the United States. Menactra vaccine contains three of these four serogroups, representing approximately two-thirds of meningococcal disease overall and up to 83 percent in the adolescent population. In the United Kingdom, by contrast, two serogroups (C and B) predominate. Currently there is no vaccine available in the United States or the United Kingdom against meningococcal disease caused by the B serogroup.

Source: Aventis Pasteur; sanofi-aventis Group