U.S. Orders Vast Supply of Vaccine for Smallpox

http://www.nytimes.com/2001/11/29/politics/29SMAL.html

November 29, 2001

BIOTERRORISM

U.S. Orders Vast Supply of Vaccine for Smallpox

By SHERYL GAY STOLBERG with MELODY PETERSEN

ASHINGTON, Nov. 28 — The Bush administration said today that it had awarded a $428 million contract for 155 million doses of smallpox vaccine. That amount, when coupled with supplies that already exist or have been ordered, should be enough to protect every American against the deadly virus.

The vaccine, which will be manufactured by a joint venture of Acambis, a small Massachusetts biotechnology company, and Baxter International, a large medical products company, will be delivered to the government next fall, said Tommy G. Thompson, the secretary of health and human services.

"By signing this contract, we have created a stockpile of security against the smallpox virus," Mr. Thompson said in announcing the step at an afternoon teleconference with reporters. He said there would be enough vaccine "to protect every man, woman and child in America."

But the vaccine will not be used to immunize Americans immediately against smallpox, a disease that was declared eradicated worldwide in 1980. Rather, it will be kept in a government stockpile for use in the event of a terrorist attack with the smallpox virus.

Officially, the virus exists only in two repositories sanctioned by the World Health Organization — one in Russia, the other at the Centers for Disease Control and Prevention, in Atlanta. But many terrorism experts believe that other nations, including Iraq and North Korea, have clandestine stocks.

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The probability of a smallpox attack is low, officials say. But the disease is highly contagious, and kills 30 percent of its victims.

Because the United States stopped routine vaccination against smallpox in 1972, and because immunity among those vaccinated earlier has probably worn off, the nation is especially vulnerable to the virus. Experts estimate that an intentional release of it could create an epidemic that would affect millions.

Mr. Thompson said more than a month ago that the government intended to stockpile the vaccine. But the plan he announced today is slightly different from the one he spoke of then.

Instead of buying 300 million doses, as he initially said, the government will buy 209 million doses — the 155 million being made by Acambis/ Baxter, plus 54 million that have already been ordered from Acambis.

The government also has 15.4 million doses, left over from the 1970's, in storage. The National Institutes of Health is running an experiment to determine if the vaccine can be diluted to stretch that supply to 77 million doses, which would bring the stockpile to 286 million doses — roughly one dose for every American.

The dilution tests will not be complete until February, but the early results "have been very gratifying," said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. "I would be very surprised," Dr. Fauci said, "if we were not able to have the 1-to-5 dilution available to us."

In choosing Acambis and Baxter, the government bypassed two of the nation's largest vaccine manufacturers, Merck and GlaxoSmithKline, which had also bid for the contract. Mr. Thompson said that the Acambis/Baxter price, $2.76 a dose, was lower, and that Acambis and Baxter had also agreed to provide the vaccine sooner than their competitors.

Mr. Thompson said Acambis had done considerable research on smallpox vaccine as a result of the government contract it already held.

"Their research and development," he said, "was such that we felt very comfortable with them."

The contract is a significant boost to Acambis, which is developing vaccines against several diseases but does not yet have a product on the market.

The new smallpox vaccine to be produced by Acambis and the one to come from the joint venture will be made, like the old vaccine, from a live pox virus called vaccinia. But the new vaccines will be manufactured using more modern methods, and there will be slight differences between them.

Both will require clinical trials and the Food and Drug Administration's approval, but testing will start as soon as production of doses begins, and, in an emergency, the vaccines could be administered even before formal approval by the F.D.A.

There is no way to know whether the new vaccines will be any safer than the old, experts say. Studies of people who received smallpox vaccinations in the 1960's have shown that one in one million died, mostly of encephalitis. Other complications were more common.

So experts say it would be dangerous to do widespread vaccination in the absence of evidence of a bioterrror attack.

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.