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RESPONSE TO TERROR | GERM WARFARE

U.S. Panel Calls for Vaccine Center

Bioterrorism: The government should step in because the operation is too complex for the private sector, commission says.

November 02, 2001|CHARLES ORNSTEIN | TIMES HEALTH WRITER

WASHINGTON — A federal commission recommended Thursday that the government create a facility to develop and produce vaccines to combat bioterrorism.

The panel, headed by Virginia Gov. Jim Gilmore, said a national laboratory is vital to respond to a massive biological attack.

"The private sector is unlikely to be the answer to some of the more difficult vaccine issues," said the bipartisan panel, which was appointed by Congress in 1999.

"Direct government ownership or sponsorship is likely to be the only reasonable answer for producing vaccines for certain bio-organisms--anthrax and smallpox being at the top of the list," the panel said.

This summer, the Defense Department estimated that it would cost $1.56 billion to build a vaccine plant and run it for 25 years.

Only one company produces anthrax vaccine, but its factory has not been able to ship any doses for three years because of production problems.

The Food and Drug Administration is expected to inspect the factory soon, and BioPort Corp. could resume shipments by month's end.

Federal officials have awarded a contract to another company, Acambis, to produce 54 million doses of smallpox vaccine.

The Health and Human Services Department is in the process of selecting other companies to produce 250 million more doses by next year. Health and Human Services Secretary Tommy G. Thompson said his department had whittled its list to four candidates, and those companies must submit detailed proposals by Monday.

Because of the bioterrorism threat, companies will be allowed to bypass the standard testing regimen for vaccine makers, Health and Human Services officials said. Some testing will be conducted once the vaccine is made.

"There's no question that overlapping the production with the early phases of clinical testing is not usually done in the vaccine field," said retired Army Maj. Gen. Phillip Russell, named Thursday as a special advisor on vaccine development and production.

But there isn't time to break the two steps apart, he added.

The government has a stockpile of 15.4 million doses of smallpox vaccine, which were grown inside calves. But federal guidelines have changed since the nation stopped vaccinating against smallpox in 1972, and new doses must be grown in tissue cell cultures.

Dr. Donald A. Henderson, who led the worldwide smallpox eradication effort, said the fast production schedule does not concern him.

"It is not in any sense a new vaccine," said Henderson, who was appointed Thursday as director of the new Office of Public Health Preparedness. "We know its efficacy."

Thompson has said he has no plans to vaccinate Americans against smallpox unless there is an outbreak.

Similarly, officials are seeking to give anthrax vaccine shots only to lab workers who test samples and to workers who decontaminate buildings.

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