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Thousands of doses of rabies vaccine recalled

Drug firm: One lot had live virus; 3 called back as precaution


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Centers for Disease Control & Prevention

(CNN) -- A vaccine maker is recalling thousands of doses of rabies vaccine after discovering through routine testing that one lot contained live virus that could potentially harm human health.

The lot had not been distributed, Aventis Pasteur spokesman Len Lavenda said in a telephone interview with CNN from the company's U.S. headquarters in Swiftwater, Pennsylvania.

As a precaution, Aventis Pasteur is also recalling three other batches of Imovax that were made at the same time, the Lyon, France-based company said.

The Centers for Disease Control and Prevention said in a statement that the lots being recalled were distributed between September 23 and April 2, and "had passed all FDA-approved release tests, including testing to confirm the absence of live virus," suggesting the risk to anyone who may have received the vaccine is small.

Still, anyone who received rabies vaccine between those dates should contact their health care provider, the CDC dispatch said. No unusual events associated with the recalled vaccine have been reported, it added.

Rabies vaccine is made by killing live rabies virus. Injections of the dead virus stimulate the body's immune system to develop antibodies that kill the live virus.

That process went awry at the company's plant in Lyon, where a bulk vaccine filter failed, Lavenda said. That's a critical step in the production process because the solution that typically kills isolated particles of the live virus may not inactivate large particles of it, he said, adding that the filter has been fixed.

Human rabies is rare in the United States, with only 39 cases diagnosed since 1990. But doctors treat possible exposures aggressively because once symptoms develop, the disease is almost always fatal.

Two groups of people get rabies vaccines: those who have been bitten by an animal that is rabid or suspected of being rabid; and those at risk of being bitten, such as veterinarians, zookeepers and people traveling to regions where rabies is common.

Last year, in the United States, about 18,000 people at risk of being bitten got preventive vaccinations, and another 40,000 got them after being bitten.

The only people who need to do something as a result of the recall are those who received the vaccine preventively, Lavenda said. The others, in addition to getting the vaccine, would have been given immune globulin, which contains antibodies that kill live virus. Aventis will pay for those people to get an injection of immune globulin, he said.

The company is also recalling vaccines that were distributed to 18 other countries, and will be sending its customers information about the recall on Monday, Lavenda said.


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