FDA approval of Sanofi-Aventis' meningococcal conjugate vaccine Menactra appears to await final manufacturing clearance.

The Menactra BLA was filed at the end of 2003, setting an October 2004 user fee deadline. However, the vaccine has not yet been licensed by FDA (¹ Also see "Where’s Menactra? No Word From Sanofi-Aventis As User Fee Date Passes" - Pink Sheet, 20 October, 2004.).

FDA's Vaccines & Related Biologic Products Advisory Committee agreed with FDA during a Sept. 22 meeting that Menactra was shown to be non-inferior to Menomune with regard to immunogenicity and safety (² Also see "Sanofi-Aventis' Menactra Post-Approval Commitments Should Include Long-Term Safety, Efficacy Data" - Pink Sheet, 22 September, 2004.).

Committee members requested that Aventis conduct a number of safety and efficacy trials in postmarketing. However, it appears that approval awaits manufacturing clearance.

During an Oct. 27 meeting of the Centers for Disease Control & Prevention's Advisory Committee for Immunization Practices, Aventis said it is prepared to produce a limited supply of the vaccine soon after FDA licensure.

However, the company indicated that projected supplies for 2005 would be insufficient to meet ACIP's proposed recommendations for MCV-4 vaccination. The proposed recommendations call for vaccinating adolescents ages 11-12, 12-19 year-olds as part of a catch-up campaign, college freshmen living in dorms and other groups at increased risk.

Aventis said that a new Menactra manufacturing facility is under construction and will require two to three years before it can provide sufficient doses to meet ACIP's draft recommendations.

-Andrew Kasper

Menactra Approval Awaits Final Manufacturing Clearance

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