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Smallpox Vaccine Cache a Windfall for U.S.

Aventis donates millions of doses in cold storage for decades

FRIDAY, March 29, 2002 (HealthDayNews) -- The drug giant Aventis Pasteur announced today that it would donate to the government 75 million-to-90 million doses of smallpox vaccine it has been keeping in cold storage for decades.

Health officials said the move could provide a short-term "safety net" against a smallpox attack -- provided the doses are still effective against the devastating virus. Aventis said the government has known about its smallpox vaccine for "many years," and that the company reminded officials of the supply after the Sept. 11 terror attacks. But word of the doses didn't become public until yesterday.

"If we determine that the Aventis vaccine remains effective, we could substantially boost our nation's smallpox vaccine stockpile at relatively little cost to taxpayers," Health and Human Services Secretary Tommy Thompson said in a statement. "The Aventis supply could provide an added safety net should we need to vaccinate against smallpox."

"We are offering both short-term and what we hope will be long-term relief from concerns about vulnerability to smallpox as an agent of bioterrorism," Richard J. Markham, chief executive officer of Aventis Pharma, Aventis Pasteur's French parent company, said in a statement. "We hope that a dose will never be needed, but we are gratified that we will be able to contribute to the immediate need for building the stockpile."

The company said the market value of the doses topped $150 million, although it did not say how it arrived at that figure. It could not be immediately learned whether Aventis would receive a tax break for the donation.

Bill Hall, an HHS spokesman, said the government decided not to disclose the vaccine cache before now because "we didn't know if it was good or not." Although initial tests appear "very encouraging," officials said, the lots must undergo human testing by the National Institutes of Health to determine their potency.

The vaccine had been stored in the company's Pennsylvania facility for more than 30 years, and the Associated Press quoted a company spokesman as saying that the big problem originally had been how to get rid of the sera. "We had actually been developing protocols with the (Centers for Disease Control) to destroy it,'' Aventis Pasteur spokeswoman Beth Waters told the wire service.

Hall said the Aventis doses will be an "insurance policy" in the event of a bioterrorism attack with smallpox before the government can secure enough vaccine to cover the entire population. However, he said, the trove will not deter the government from its plans to buy 209 million doses of new vaccine from Acambis Plc. and Baxter International, Inc., two pharmaceutical companies developing a modern version of the inoculation.

Nor does the Aventis stock mean the administration will not press ahead with its plans to dilute the existing supply of 15.4 million "Dryvax" doses, held in storage since 1982. A study released yesterday showed that even at a dilution of one-to-10, the vaccine generated immune responses to smallpox in at least 97 percent of the people who received it. Health officials have expressed a desire to create 75 million doses out of the original supply, a one-to-five dilution.

Dr. Tara O'Toole, director of the Center for Civilian Biodefense Studies at Johns Hopkins University in Baltimore, said the government wasn't remiss in waiting to disclose the Aventis vaccine. "I think it was a reasonable decision," O'Toole said. "They were trying to figure out if it was real, if it was any good."

However, health officials have openly discussed the possibility of diluting the Dryvax stock since last fall, even when they were unsure whether thinning it out would work and whether it remained effective even at full strength.

Routine smallpox vaccination in the United States ended in 1972. The skin-prick inoculation, which is not an injection, provides near perfect protection against the deadly virus. However, it can also cause fatal reactions, especially in people with suppressed immune systems or a history of eczema. Experts estimate that roughly 180 Americans would die from the vaccine if the entire nation -- excluding those at high risk of complications -- were immunized. That's equal to the number of people killed in traffic accidents every 1.5 days.

Half the population of this country has never been vaccinated against the virus. Experts said it's unclear if those who were immunized are still protected.

What To Do: For a history of the smallpox vaccine, check out Stanford University. For more on bioterrorism and what officials are trying to do to stop it, try the National Memorial Institute for the Prevention of Terrorism or the Centers for Disease Control and Prevention.

SOURCES: Tara O'Toole, M.D., M.P.H., director, Center for Civilian Biodefense Studies, Johns Hopkins University, Baltimore; Bill Hall, spokesman, U.S. Department of Health and Human Services, Washington, D.C.; Health and Human Services, Aventis Pharma press releases
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