Health
FDA committee recommends approval of meningococcal disease shot
NEWS IN BRIEF — Posted Oct. 11, 2004
The Food and Drug Administration's Vaccine and Related Biological Products Advisory Committee recommended that Menactra, the first quadrivalent conjugate meningococcal vaccine, be approved by the agency, according to a statement issued in September by the product's manufacturer, Aventis Pasteur.
The FDA is not bound by such recommendations, although it usually follows them.
The vaccine would protect those ages 11 to 55 against meningitis and sepsis caused by four of the most common groups of meningococcal bacteria. The currently available vaccine only includes three groups and provides protection for three to five years. The new vaccine may last longer, although that is expected to be the subject of studies after approval.
"We are very pleased with the positive response," said Michael Decker, MD, MPH, vice president of scientific and medical affairs at Aventis. "If licensed by the FDA, we intend to have the vaccine available as quickly as possible."
The company is building a new factory in Swiftwater, Pa., in order to meet expected demand.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2004/10/11/hlbf1011.htm.