Voluntary Voluntary Smallpox Vaccination Urged
Offer to General Population Represents a Shift in Policy

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By a Washington Post Staff Writer
Saturday, October 5, 2002; Page A01

The Bush administration's top bioterrorism advisers said yesterday they support a voluntary smallpox vaccination program that would begin with 500,000 health care workers, expand to 10 million emergency responders and extend to the rest of the population as early as 2004.

It was the first time high-ranking administration officials acknowledged they are considering offering the risky vaccine to the public prior to an attack and it represented a profound shift in thinking from the June recommendations of a government advisory panel to inoculate about 20,000 medical personnel.

"We live in a society that values individual choice," said Julie L. Gerberding, director of the Centers for Disease Control and Prevention. "If we have vaccine and we have data to accurately assess the safety, one school of thought is that informed people may want to have the choice of getting vaccine or not."

In a 90-minute briefing at the Department of Health and Human Services, the group of officials responsible for implementing a bioterror response plan laid out the options before President Bush, stressing that he has yet to make a decision on who could be vaccinated and when. If a smallpox case were detected, officials would assume the nation was under attack and would quickly move to nationwide vaccination.

Developing a "pre-attack" vaccination policy, however, has proven to be "extremely difficult" because of the challenge in balancing the possible risks of the vaccine against the risks of an attack, said Jerome M. Hauer, assistant secretary for emergency health preparedness.

Although they have no way of knowing the likelihood of a smallpox attack, health experts fear such an attack because the virus is so contagious and so deadly. About one-third of people who get the disease die, yet the vaccine itself can cause serious, sometimes fatal, complications.

Concerns that Iraq or another hostile nation may have acquired the virus have added urgency to the vaccination debate. "We need to be mindful that the context of this decision has changed a bit" since the far more conservative June recommendations, Gerberding said.

Vice President Cheney has speculated that the threat from Iraqi President Saddam Hussein may necessitate mass vaccination. Privately, sources said Cheney has vigorously advocated a broad vaccination policy. White House spokesman Scott McClellan said last night the policy "is under review" but he could not elaborate on a timetable or factors involved in the decision.

Since last fall's anthrax attacks, federal health officials have moved swiftly to build up the nation's smallpox vaccine stockpile. If an attack occurred today, they said they could safely dilute the existing supply to inoculate every American. By the end of next year, they expect to have 209 million doses of new vaccine on hand. None of the vaccine has been licensed by the Food and Drug Administration, but officials expect the first batches will be approved by November.

At the request of the Department of Defense, Hauer said HHS will provide the first 1 million doses of licensed smallpox vaccine to the military within the month. Pentagon spokesman James Turner refused to comment.

For civilians, the HHS team favors a policy of "ever-expanding access to vaccine" that could be phased in as more vaccine is licensed and scientists have time to monitor early reactions to it. Using licensed vaccine would be much easier logistically than administering it as an experimental treatment that involves tricky liability issues.

The approach envisions vaccinating the people considered to be at greatest risk if an outbreak occurs. That would include public health investigators, emergency room workers and even janitors and security guards at local hospitals.

The goal in the early stages, Gerberding said, "is to maximize our ability to respond to an attack should one occur."

In the second phase, as many as 7.5 million medical workers would be offered vaccine, along with the nation's 3 million firefighters, police officers and rescue workers, Hauer said. Inoculating that many emergency personnel "would make it even easier to respond" to an attack, Gerberding explained. It is possible Bush would combine the first two phases and opt to inoculate the majority of first responders immediately.

At some later date, perhaps in early 2004, vaccine could be offered to every American. "Right now, our thinking is in favor of making vaccine available to the general public," Gerberding said.

Federal health officials rejected the advice of its advisory panel to designate certain smallpox hospitals because Hauer said it was unrealistic to think patients would follow those guidelines.

America stopped routine vaccination in 1972, which means about 45 percent of the population has never been inoculated. It is unclear how much immunity remains from vaccines given 30 or 40 years ago.

Between 30 million and 50 million Americans should not be given the vaccine because they have weak immune systems, said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. That includes people who have received chemotherapy, have eczema or are infected with the AIDS virus. For every 1 million vaccinated, 15 people are likely to suffer life-threatening complications and one or two would die.

Because there is limited scientific data, it is difficult to predict the risks of a person spreading the virus in the vaccine to others. Administration aides are still grappling with the liability issues of reviving a vaccination program.

State health officials have until Dec. 1 to file plans for mass vaccination within five to 10 days of an attack, Hauer said. In the event of an attack, he observed, "Five days might be a luxury."

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