The Food and Drug Administration (FDA) is likely early this year to approve the quadravalent meningococcal conjugate vaccine (A, C, Y and W135 polysaccharides), Menactra, for use in 11- to 55-year-olds.

Last September, the FDA's Vaccine and Related Biological Products Advisory Committee voted unanimously that data presented by Aventis Pasteur was sufficient for FDA approval of Menactra (MCV-4). Six clinical trials involving 7,642 adolescents and adults compared MCV-4 to the licensed quadravalent A, C, Y and W-135 polysaccharide vaccine (Menomume) and proved "non-inferiority" of MCV-4 in efficacy (defined by the serological correlate of serum bactericidal antibody responses). The trials also demonstrated the safety of MCV-4.

In October, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention reviewed preliminary recommendations from the Meningococcal Working Group for use of MCV-4. Final ACIP recommendations for routine use of MCV-4 in adolescents are anticipated on Feb. 10, once...

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