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http://www.nytimes.com/2002/12/18/science/sciencespecial/18VACC.html?tntemail1

Company Says It Will Test a Safer Smallpox Vaccine

By ANDREW POLLACK

California biotechnology company said yesterday that it had acquired the American rights to a Japanese smallpox vaccine it says is safer than the one the Bush administration plans to use.

The company, VaxGen, said it hoped to begin clinical trials early next year and to win approval from the Food and Drug Administration to begin sales in 2004. If the vaccine is approved, the company plans to market it commercially, hoping it will appeal to millions of consumers who want some protection against bioterrorism but fear the side effects of the existing vaccine.

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On Friday, the administration announced plans to use stocks of an existing vaccine to immunize half a million troops and up to 10 million civilian health care and emergency workers by late spring, and to make a newer version of the vaccine available to the public by 2004. But scientists have warned that the vaccine can cause serious side effects in a small number of recipients, including brain inflammation and death.

By contrast, the Japanese vaccine was tested in 50,000 small children in the 1970's and was approved there in 1980. It caused no serious side effects and fewer cases of fevers and redness on the arm than conventional vaccines, VaxGen said. But the Japanese vaccine did produce the characteristic scab on the arm, a sign of effectiveness, in more than 90 percent of the children.

Still, some American experts say there is not enough data to show that the vaccine is safe and effective. Like the conventional one, the Japanese vaccine consists of a live vaccinia virus, a cousin of the smallpox virus. But the Japanese virus is attenuated, chosen to be weak and to produce fewer signs of brain inflammation than the conventional vaccines in animal tests.

Dr. Lance K. Gordon, the chief executive of VaxGen, said he had been working on spurring interest in the Japanese vaccine for four years. Dr. Gordon, an immunologist, was formerly the chief executive of OraVax, now known as Acambis, the company that has contracts from the United States government to produce 209 million doses of a new version of the conventional vaccine. Dr. Gordon helped negotiate the first of those contracts.

But he said the Acambis vaccine, while produced with more modern methods than the existing vaccine, would not be much safer because it used the same strain of virus. He added that its risks would be acceptable if there were a bioterror attack, but that in the absence of an attack, "it's certainly likely that the adverse events will outweigh any risks from smallpox."

Dr. Gordon's comments raise the question of whether the government should have considered the Japanese vaccine when it decided to build its stockpile. But government officials say they had to go with what had been proved to work.

"We had to build the stockpile based on proven efficacy and proven acceptability to the F.D.A.," said Dr. Philip Russell, special adviser on bioterrorism vaccines in the Department of Health and Human Services. Acambis declined to comment.

Dr. Russell said that since the Japanese vaccine had been developed after smallpox was eradicated in Japan, "there's no historical proof that it works." He also said the vaccine was made in an unusual type of cell culture that might not pass muster with the drug agency.

Nevertheless, he said the government was pleased that VaxGen had licensed the vaccine because it might provide an option for the future.

VaxGen executives said it was not clear whether the government would buy any of its vaccine for the stockpile. But investors apparently saw a big opportunity in the potential for commercial sale, and VaxGen's stock rose $1.87, or 12 percent, to $17.60 yesterday.

Dr. Donald Francis, the president of VaxGen, conceded that the testing in Japan in the 1970's might not have been extensive enough to detect serious complications, which are rare even in the conventional vaccine.

Moreover, since the Japanese vaccine is a live virus, it is not likely to be recommended for people who should not take the existing vaccine, like those with compromised immune systems or certain skin disorders, VaxGen executives said.

The National Institutes of Health is searching for safer smallpox vaccines. One candidate, on which it is starting research, is made from a strain of virus known as M.V.A. that is so weak it is said not to be able to replicate in humans.

VaxGen, based in Brisbane, Calif., is mainly known for its experimental AIDS vaccine, which is in the final stages of clinical trials.

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