LIVE VIRUS DISCOVERED IN RABIES VACCINE

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Posted April 8, 2004
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LIVE VIRUS DISCOVERED IN RABIES VACCINE
By Daniel Yee | The Associated Press

ATLANTA -- A rabies vaccine for humans is being recalled in the United States and 23 other countries because a live strain of the virus was found in another batch made at the same time.

Testing of Aventis Pasteur's IMOVAX vaccine revealed the presence of a live Pittman-Moore strain of the rabies virus, when the drug was not supposed to contain live virus, the federal Centers for Disease Control and Prevention said.

While the tested lot of the vaccine was never distributed for public use, Aventis recalled four other lots in the United States because they were made during the same time as the faulty lot. The CDC said those lots had all passed quality tests.

The CDC said it was theoretically possible but unlikely that anyone who received rabies shots from the recalled lots could have been exposed to the live form of the virus.

As a result, the CDC has recommended that people who have taken recalled rabies shots receive additional shots of the vaccine that have not been recalled.

The recalled lots, X0667-2, X0667-3, W1419-2 and W1419-3, were distributed between Sept. 23 and Friday, company officials said.

Twenty-one other lots were being recalled in 23 other countries, according to information from the vaccine manufacturer posted Wednesday on a Web site for infectious-disease doctors. The lots recalled overseas also passed quality tests, the CDC said.

There is no scientific data on the effect of exposure to the Pittman-Moore rabies virus, which differs from the wild rabies virus, but according to anecdotal accounts lab workers exposed to it "never had any adverse consequences," said Len Lavenda, a spokesman at the company's offices in Swiftwater, Pa.

A vaccine expert said Aventis did not have to recall the lots because they had been tested and did not carry the live virus.

"This really was an excess of caution and a very elaborately cautious response," said Dr. William Schaffner, head of preventive medicine at Vanderbilt University Medical Center. He called it "exceedingly responsible."

The other countries affected by the recall were: Angola, Australia, Botswana, Croatia, Denmark, Chad, Germany, Hong Kong (China), Ireland, Italy, Malawi, Mozambique, New Zealand, Netherlands, Norway, Nigeria, Oman, Spain, Switzerland, United Arab Emirates, United Kingdom, Zambia and Zimbabwe.

NVIC's Barbara Loe Fisher Note:

Despite government and industry assurances that no lots of rabies vaccine contaminated with live rabies virus were released for public use, it is interesting that government and industry are urging those who got vaccine from the lots in question be immediately revaccinated. Getting a series of rabies shots is not risk-free. The fact that revaccination is being urged calls into question whether there is more than a theoretical possibility lots of rabies vaccine containing live virus were indeed released in the US and around the world. For more information on this story, go to the CDC website: www.cdc.gov/ncidod/dvrd/rabies/Ques&Ans/q&a_vaccine_recall.htm

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