U.S. Asks Potential Vaccine Makers of Smallpox for Data by Tomorrow
Dow Jones Online News, Tuesday, October 23, 2001 at 00:34
WASHINGTON -- In an urgent request, the federal government is asking firms interested in making a smallpox vaccine to submit by tomorrow detailed information about their capability to produce millions of doses, Tuesday's Wall Street Journal reported.
The letter, from the Department of Health and Human Services, said that the firms will have to demonstrate an ability "to develop, manufacture and deliver up to 250 million doses of smallpox vaccine within a 12-month period."
The tight deadlines underscore the government's concerns about the potential use of smallpox as a biological weapon. Smallpox is considered far more dangerous than anthrax.
The request for information, as it is called, is dated Oct. 19, just a few days after HHS Secretary Tommy Thompson publicly announced that the government plans to buy 300 million doses of smallpox vaccine by the end of next year. "It will be a tough push, but I think we can do it," he said yesterday after a speech to the American Public Health Association in Atlanta.
Yesterday afternoon, he said that smallpox vaccinations are effective in preventing disease if they are administered one to three days after a person is exposed to the virus. "If a smallpox epidemic broke out," he said, "we'd inoculate the first responders," such as policemen and health-care workers, and then vaccinate the public. "We think we'd be able to control it that way." The vaccines will be kept in the government stockpiles until needed.
HHS already has ordered more than 50 million doses for delivery next year from Acambis PLC, a British company with facilities in Cambridge, Mass. The government now is looking for the rest of the supply.
"Due to usual and compelling urgency of this requirement, the government will bypass the standard procurement process and expedite procedures for the procurement of 250 million doses of smallpox vaccine," the HHS letter said. The government, it said, reserves the right to make a single purchase of 250 million doses or multiple purchases of 50 million each. It also asked for prices per 50 million doses.
The government wants to know the drug makers' experience in producing vaccines and how they will develop the new smallpox vaccine. In addition, it is seeking details on planned clinical trials, product licensure by the Food and Drug Administration and how the vaccines will be stored and shipped. It specified that the smallpox vaccine should be "partially purified vaccinia virus packaged wet-frozen or in freeze-dried units of 100 doses per container when administered by bifurcated needle."
The letter was signed by Charlotte Flitcraft, an HHS contracting officer.
Secretary Thompson said last week that he has been discussing the smallpox issue with four pharmaceutical companies, including Merck & Co. and Baxter International.
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