Aventis Pasteur filed a biologics license application for Menactra, a conjugate vaccine believed to provide protection against meningococcal meningitis for a longer period than the company's currently marketed product.
The company is seeking FDA approval for use of Menactra Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine in people 11 to 55 years old. Menactra is designed to offer protection against four sero-groups of meningococcal disease, including A, C, Y and W-135.
Aventis Pasteur, the vaccine business of Aventis SA, of Lyon, France, is pleased about filing for Menactra because it is a conjugate vaccine that can fight off the rare but deadly disease longer than the polysaccharide Aventis has been making for years.
"The vaccine we have today is given to college students because it only provides three to five years of immunity, so if we gave it to younger kids, it would not provide the kind of protection that they would need when they get to college," Len Lavenda, spokesman for Aventis Pasteur, told BioWorld Today. "At this point in time, we can't say conclusively what duration of protection [Menactra] will offer because it hasn't been studied long enough. However, we do know that Menactra induces a T cell-dependent immune response, which has been associated with long-term protection in other conjugate vaccines, so we believe it will provide longer duration of immunity."
Therefore, it is believed that an 11-year-old who is vaccinated with Menactra (also called MCV-4) will be protected through college. According to the company's statistics, meningococcal disease, the leading cause of bacterial meningitis, strikes between 2,500 and 3,000 Americans each year, killing up to one in five.
Lavenda would not speculate as to when the company expects FDA action. However, he said the company plans to file for European approval for ages 2 to 55 before the end of 2004. Sometime thereafter, Aventis Pasteur will file for U.S. approval in children younger than 11 years of age.
As a conjugate vaccine, Menactra was created by attaching the meningococcal polysaccharides to a carrier protein. The company said that since 1990, vaccines using conjugate technology have reduced Haemophilus influenzae type B and Streptococcus pneumoniae, two infections that have been major causes of meningitis in young children.
The currently approved vaccine is made from a long chain of polysaccharides that comes from the outer coat of the meningococcus bacterium.
The BLA package, filed electronically, is based on six pivotal studies involving more than 7,500 participants who received Menactra. According to the company, Menactra has an excellent safety and immunogenicity profile.
Lavenda said Aventis Pasteur is constructing a production facility in Swiftwater, Pa., where it is headquartered, to make the vaccine. The new facility is intended to ensure the company's ability to meet anticipated demand for the product.
Aventis' stock (NYSE:AVE) closed Tuesday at $63.93, up 41 cents.