>>Maker of Smallpox Vaccine Cites Progress
By Justin Gillis
Washington Post Staff Writer
Thursday, September 19, 2002; Page A12
The company making a new smallpox vaccine for a U.S. government stockpile said yesterday that it had packaged its first finished doses and
hinted that it may fulfill its promise to deliver millions of additional doses by the end of the year.
The statements by Acambis PLC were the most definitive information to emerge about the status of one of the Bush administration's key
commitments in the war on terrorism. Fearing an attack with deadly smallpox, the government wants to have enough vaccine on hand for every
American by the end of this year.
In a quarterly earnings update from London, Acambis executives said they had made considerable progress in renovating a plant in Canton,
Mass., where some of the smallpox work is being done. They have completed a series of preliminary human tests of their vaccine, with 100
percent of the test subjects showing evidence of successful vaccination. That suggests the vaccine, made by state-of-the-art techniques, is at
least as potent as the crude but highly effective vaccine that eliminated smallpox a generation ago.
"I am delighted to report that the first doses of final, filled and kitted smallpox vaccine have been produced for the U.S. stockpile," said John
Brown, chief executive of Acambis. "This is a major milestone for the company."
Executives at the company declined to be precise about its delivery schedule for the vaccine, citing national security. "We're not making any
comment on the timing of delivery of doses . . . for confidentiality reasons," said Gordon Cameron, Acambis's chief financial officer.
But during a detailed discussion of company finances, he said Acambis may be in a position to bill the government for large amounts of vaccine
in December. That step would not normally happen, under government rules, until the vaccine has been delivered and formally accepted into
federal stockpiles.
The government's smallpox efforts have been underway for years but were stepped up after the attacks last fall with another biological agent,
anthrax.
Smallpox is potentially the deadliest of all bioterror weapons, because the U.S. population has little immunity. The last known stocks of smallpox
virus are supposed to be under lock and key in Atlanta and at a laboratory in Russia, but there is fear that terrorists or hostile states like Iraq
could have acquired the virus in recent years.
To address that concern, Tommy G. Thompson, secretary of the Department of Health and Human Services, promised last year to acquire
enough vaccine to protect "every man, woman and child in America."
Over the past year, the government has scraped together about 100 million doses of old vaccine, and studies suggest it could be safely diluted
to make enough doses for the entire U.S. population of 288 million. But most experts have said that stockpile -- all of it decades old -- needs to
be replaced with a purer, fresher vaccine made with modern production techniques.
Late last year, Thompson's agency chose Acambis to supply about 209 million fresh doses of vaccine, prompting concern about whether the
small British biotechnology company was up to the task. But Acambis formed a partnership with Baxter International Inc. of Deerfield, Ill., to
work on the project and has reported steady progress all year.
The HHS maintained its long-standing silence yesterday on how well the Acambis work is going. "We are making no comments regarding the
exact status of the contract and its fulfillment," said agency spokesman William Pierce.
Debate continues within the Bush administration about how widely to deploy smallpox vaccine in the absence of a confirmed attack. The
vaccine sickens or kills a small percentage of people who receive it, so mass vaccination of Americans is considered unlikely, at least in the near
term. The administration does appear to be moving toward vaccination of tens of thousands of hospital workers and others who would be on
the front lines of an outbreak.
Acambis yesterday disclosed results of a new test of its vaccine. Seventy people got smallpox shots in the test, the company said, and all 70
developed the pustule and reddening characteristic of successful vaccination.<<
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