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4/5/2004

Imovax Rabies Vaccine Recalled

Cheryl A. Thompson

Aventis Pasteur USA on Friday announced a recall of Imovax rabies vaccine lots X0667-2, X0667-3, W1419-2, and W1419-3 because of a problem discovered in a lot that was not distributed. Federal health authorities said certain persons who received a dose from any of these four lots need further vaccination.

The company described the recall as a precautionary measure. All rabies vaccine lots produced at the same time as the lot that did not pass quality assurance tests are being recalled. Aventis Pasteur said it released the recalled lots from September 23, 2003, through April 2, 2004.

The Centers for Disease Control and Prevention (CDC), in a special communication (PDF), reported that the company had found live, rather than attenuated, Pitman-Moore rabies virus in the undistributed lot.

Aventis Pasteur said the four lots being recalled passed all the quality assurance tests required before distribution, including tests confirming the absence of live rabies virus. CDC said these test results "suggest that any potential risk to those vaccinated with recalled vaccine is likely to be low."

In its April 2 MMWR Dispatch, CDC suggested that health care providers identify patients who received a dose of recalled vaccine and selectively administer more vaccine (from a lot not being recalled) or rabies immune globulin, depending on the original reason for vaccine administration and the number of doses already given.

A spokesman for Aventis Pasteur said the company concurred with CDC's recommendations. "We essentially are assuming a worst-case scenario," said Len Lavenda.

Health care providers and consumers who want more information have been told to call 1-800-835-3587, where they may await a live operator or leave a message.