Sanofi-Aventis meningitis vaccine licensed by FDA
Menactra vaccine is the first quadrivalent conjugate vaccine licensed in the US for the prevention of meningococcal disease and is designed to offer protection against four serogroups of Neisseria meningitidis (A, C, Y, W-135), the bacterium that causes meningococcal infection. The US Centers for Disease Control and Prevention's (CDC) advisory committee on immunization practices (ACIP) has formed a working group that is updating the recommendations for the prevention and control of meningococcal disease. The ACIP is expected to approve any changes in recommendations during the February 2005 committee meeting. "The FDA licensure of Menactra vaccine, if it is coupled with wide-spread meningococcal immunization, represents a significant step toward eradicating this devastating disease," said Dr Michael Pichichero, professor of microbiology/immunology, pediatrics and medicine at the University of Rochester Medical Center Although meningococcal disease rates are highest in infants, rates begin to rise again in early adolescence and peak between the ages of 15 and 24. The FDA's decision to license Menactra vaccine was based on safety and immunogenicity data from six pivotal studies, which included more than 7,500 adolescents and adults receiving Menactra vaccine. Menactra vaccine induced the production of functional antibodies specific to the capsular polysaccharides of the four serogroups (A, C, Y and W-135) found in the vaccine. All vaccine immunogenicity measurements demonstrated strong immune responses to a single dose of Menactra vaccine that were equivalent to a single dose of Sanofi Pasteur's Menomune-A/C/Y/W-135. Sanofi Pasteur will work closely with the CDC in an effort to ensure production schedules that will support the implementation of anticipated new immunization recommendations. Additionally, the company is building a production facility at its US site in Swiftwater, Pennsylvania, to increase the production of Menactra vaccine to meet anticipated demand. A supplemental licensure application in the US for use of Menactra vaccine in children younger than 11 years is planned for early 2005. Additional submissions for licensures are planned for Canada in 2005 and at a future date for Europe.