Sanofi-Aventis says that its Menactra vaccine has won US Food and Drug Administration approval to protect adolescents and adults aged 11-55 against meningococcal meningitis – a potentially fatal infection. Menactra vaccine is the first quadrivalent conjugate vaccine licensed in the US for the prevention of infection from four types of meningococcal disease.
Approval, which comes four months after the vaccine won the backing of an FDA advisory panel [[23/09/04d]], [[22/12/03c]], was based on safety and immunogenicity data from six pivotal studies, including more than 7,500 adolescents and adults receiving Menactra vaccine. Data showed that Menactra elicited an immune response equivalent to a single dose of Sanofi’s older meningitis vaccine, Menomune.
A supplemental application in the US for use of Menactra in children younger than years is planned for early 2005, with additional submissions planned for Canada in 2005 and at an as-yet undetermined future date for Europe.
