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10/21/2002

Meningococcal Vaccine Recalled by Firm

Cheryl A. Thompson

Aventis Pasteur Inc. is recalling single-dose vials of its meningococcal polysaccharide vaccine because the solution may not adequately protect against serogroup A disease, a type not known to originate in the United States.

According to a letter dated Oct. 18, the company suggests that health care providers consider revaccinating people who received a dose of Menomune-A/C/Y/W-135 since Jan. 2, 2001, and who work with Neisseria meningitidis serogroup A or travel to countries where it is responsible for epidemic or endemic meningococcal disease. Africa's "meningitis belt" and Great Lakes area have been responsible for epidemic or endemic serogroup A meningococcal disease, according to epidemiologic experts. Revaccination doses can be obtaining by calling Aventis Pasteur's medical information services department at 800-752-9340.

Note: Africa's Great Lakes area includes parts of Burundi and the United Republic of Tanzania.

The recall does not involve the 10-dose vials.

Tests performed by the company indicate that the vaccine in four lots of the single-dose vials met the potency standards for serogroup A when initially released to customers and six months later but not at 12 months. The company believes, according to its letter, that all vials in the four lots and all other single-dose vials of the vaccine were used within the first six months and, therefore, "it is likely" that vaccinees are protected against serogroup A meningococcal disease.

Health care providers who have single-dose vials of the vaccine in inventory should call Aventis Pasteur at 866-311-7244 to receive credit for the product.

Update 24 October 2002—The company has clarified its instructions on returning vials of Menomune-A/C/Y/W-135 for credit. Credit will not be given until the vials have been received by Aventis Pasteur.