Smallpox Vaccination for Medical Workers Proposed

By Ceci Connolly, Washington Post Staff Writer

Federal health officials have recommended that President Bush adopt a multiphase smallpox vaccination program for emergency medical personnel considered most at risk in the event of a bioterrorist attack. Some of those officials estimate that as many as a half-million hospital workers could be offered the vaccine.

Health and Human Services Secretary Tommy G. Thompson said yesterday that he has sent to the White House a plan designed to ensure the nation is adequately prepared to contain an outbreak should terrorists attempt to use the deadly virus as a weapon.

"We have to be concerned about any contingency that develops," he said. "We are prepared to go if and when it's required."

Even as he awaits Bush's decision, Thompson said he is moving quickly to resolve the legal, ethical and regulatory challenges to what would be the first broad-scale smallpox vaccination program in three decades.

"We are preparing plans for vaccinating," he said. Already, Thompson has concluded that the federal government would assume liability for any adverse side effects associated with the vaccine. He is also pressing for the speedy licensing of the vaccine by the Food and Drug Administration.

The decision on whether to resume inoculations is dominated by two uncertain risks: the likelihood of a smallpox attack and the danger of receiving the live vaccine with its serious, even fatal, side effects.

Smallpox was declared eradicated worldwide in 1980, and only the United States and Russia are known to hold small quantities of the virus. But many experts fear that a rogue nation or a terrorist group could acquire it.

"We can speculate, and people are [speculating] that North Korea and Iraq [have] it and possibly Iran and France," Thompson said in an interview. "And with that information, there's no question we have to be concerned about it and, therefore, we're getting prepared, especially if there is a war with Iraq."

Israel, for example, recently expanded its smallpox vaccinations, citing concerns that Iraq could launch a biological weapons attack on that country if the United States struck Iraq.

In June, a federal advisory panel recommended voluntary vaccinations for small teams of medical workers in each state. The chairman of the panel, Dartmouth Medical School's John Modlin, estimated that would translate into 10,000 to 20,000 people.

A month later, Thompson's two top bioterrorism experts, D. A. Henderson and Jerome Hauer, said that they expected the number to be in excess of 250,000 health care workers -- and many more people if other first responders such as firefighters and police officers are also vaccinated. "At the end of the day, the numbers could be significantly greater than 500,000," Hauer said in an interview at the time.

When asked yesterday in an interview if the thinking at HHS has changed since then, Thompson replied: "No, no." He declined to elaborate on the details of his recommendation to the White House but said he is "confident that they will make the right decision, and that decision will be made some time in the month of September."

If Bush approves the plan, state health officials would determine who would be offered the vaccine. The smallpox vaccine consists of live virus that can cause more serious complications than those caused by other vaccines. Some of the side effects include aches, fever, brain inflammation and even death.

One adviser said last week that HHS is still struggling with the logistics of administering hundreds of thousands of vaccine shots in short order.

"Who is going to administer the vaccine?" this person asked. "What about the shelf life of it? You're not going to take a 500-dose vial and only vaccinate 250 people."

The federal government has about 100 million doses of old vaccine, some of which could be safely diluted so more people could be vaccinated. If that vaccine was given today, it would be offered as an experimental treatment that requires the recipient to sign a complex consent form. Thompson said he is rushing to get the FDA to license the old stocks so that the consent forms would not be necessary. He added that he anticipates a similar approval process for the new vaccine being produced by Acambis Inc.

"The best of all worlds would be to have it licensed," he said.

Hospital workers would be the first to be offered the vaccine because analysts expect the first patients infected with the virus to go to local emergency rooms.

Initially, HHS officials expected that vaccinated health care personnel would need to take about 10 days off to prevent live vaccinia in the vaccine from being transmitted inadvertently to patients, who could then experience complications. Hospital officials have been clamoring for information on how they would fill those slots and who would pay for temporary workers.

But Thompson's advisers said yesterday that the risk of transmission appears lower than thought. "We might not need to furlough people," said Hauer. "It's being looked at."

Although the risk of a smallpox attack first reached the public consciousness last fall in the wake of the Sept. 11 attacks, Thompson said it has been a high priority since his first days in office. "I was not pleased with where we were," he said. "I immediately started looking at ways to accelerate the smallpox contract."

Yesterday, Acambis announced that it had tested its new vaccine on 30 people and had found it as safe as the earlier vaccine.

Sen. Bill Frist (R-Tenn.), a surgeon, wrote recently that once enough vaccine has been stockpiled, Americans should be able to decide for themselves whether to accept the risks of inoculation.