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© St. Petersburg Times, published October 24, 2001
WASHINGTON -- At least seven drug companies are considering ways to make about 250-million doses of smallpox vaccine by the end of next year, but some are asking for special concessions from the government.
Health and Human Services Secretary Tommy Thompson asked Congress Tuesday for $509-million to produce enough smallpox vaccine "so every American will be assured there is a dose with their name on it if it is needed."
Thompson said HHS sent a letter Oct. 19 to vaccinemakers, asking about their ability to make the smallpox vaccine by the end of 2002.
"Seven companies have indicated they would like to get involved," Thompson said.
The companies have until today to respond to the request. Some said they would not meet the deadline or that regulations would have to be waived or modified for such rapid production.
The government has about 15.4-million doses of smallpox vaccine stockpiled. A British company, Acambis, is making 54-million doses for delivery next year under a previous contract. The government will need about 250-million more doses to meet its goal, Thompson said.
Dr. Tony Fauci, head of the National Institute of Allergies and Infectious Diseases, said that the number of stockpiled doses may be expanded if a dilution experiment is successful.
Researchers now are inoculating volunteers with diluted doses to see if a weaker vaccine will still provide protection. Fauci said the results should be known by February. If the experiment is successful, it could expand the stockpiled doses to about 75-million, he said.
No American company has made smallpox vaccine since the 1980s. Most said they would have to start from scratch -- installing equipment and developing the expertise -- to begin production. The vaccine would have to meet standards set by the Food and Drug Administration.
FDA spokesman Larry Bachorik the agency would not cut corners in safety or quality.
"The FDA is committed to work long and hard if that is what is required," he said. "But the FDA will still uphold its same high standards."