Federal health officials will issue detailed guidelines today for vaccinating the entire U.S. population against smallpox within five days of an outbreak of the dreaded disease.
Intended as a blueprint for state and local health officials nationwide, the unprecedented move reveals a growing belief within the Bush administration that even one case of smallpox anywhere in the Western Hemisphere would signify a terrorist assault and should therefore trigger a far more massive response than officials had previously suggested, said two experts involved in the planning.
The manual being sent to health commissioners in the 50 states and the District of Columbia offers advice on how to operate mass vaccination clinics -- from logistical issues such as parking to the medical challenge of treating severe side effects. It offers suggestions on utilizing the National Guard, recruiting translators, building intricate data systems and contending with extreme weather conditions.
For now, the Bush administration does not anticipate inoculating the nation's 288 million residents -- partly because the threat of an attack is unknown and partly because the vaccine can cause severe, sometimes fatal, side effects. The vaccination plan would be activated only if an outbreak of the deadly disease occurred, an event administration officials characterize as unlikely but not impossible.
"This is a very detailed, thoughtful recipe for response" to a bioterror incident, said Michael Osterholm, a public health expert at the University of Minnesota who is advising the federal government. Using the template, states and cities should be able to devise plans "for vaccinating the largest amount of people in the shortest time possible," he said.
Smallpox has not been seen in the United States for decades, and the disease was declared eradicated worldwide in 1980. Still, it is perhaps the most feared biological weapon because it is contagious and often incurable, and can kill at least one-third of its victims. Since routine vaccination was halted in this country in 1971, there is little immunity left in the population and little expertise in dealing with the disease or vaccine.
Only the United States and Russia are known to possess stocks of the virus, but security experts fear a hostile nation such as Iraq may have acquired a cache of the virus. Vice President Cheney has contended the risk of attack may necessitate inoculating every American as a protective measure.
"One of the real concerns about Saddam Hussein, as well, is his biological weapons capability," he said recently on NBC's "Meet the Press." "The fact that he may, at some point, try to use smallpox, anthrax, plague, some other kind of biological agent against other nations, possibly including even the United States."
Ten months ago, Health and Human Services Secretary Tommy G. Thompson signed a $428 million contract to buy a dose of vaccine for every American. Production is under way, and the United States already has stockpiled nearly 100 million doses.
Federal experts since have been working furiously on two tracks: a vaccination program for the emergency medical workers most likely to see an initial case of smallpox, and a mass vaccination plan if an attack occurs, said Julie L. Gerberding, director of the federal Centers for Disease Control and Prevention.
"We have to be able to do both," she said in a recent interview.
Pre-vaccination, as it is known in public health, would be targeted to medical personnel, who could respond to an attack knowing they are protected. Plans are underway to begin vaccinating tens of thousands of "first responders," perhaps by the end of this year.
There have been no plans to make the vaccine available to the public in the absence of any cases. But officials have been debating what would be the best response to an outbreak. Last winter, the CDC released a blueprint for containing a smallpox outbreak based on the "ring vaccination" strategy used during the campaign to eradicate the disease. Ring vaccination involves starting with the people closest to an exposure and working out in concentric circles.
There is growing recognition, however, that although that approach worked well for a naturally occurring outbreak during a time when air travel was rare, it would be no match for a terrorist with the ability to release the virus in several locations simultaneously, said Jerome M. Hauer, acting assistant secretary for HHS's Public Health Emergency Preparedness.
"You begin with ring vaccination, but in a big outbreak obviously mass vaccination would be part of the plan," he said. Federal officials are requiring states to develop plans for vaccination within five days, he said, because it is widely believed that even if a person has been exposed to the virus, a vaccine given in that time frame will provide immunity.
Administration officials refused to release the manual until state health commissioners receive it. But in interviews with The Washington Post, several described the scenario for responding to a smallpox attack.
At the first hint of a smallpox case, the CDC in Atlanta would begin dispatching emergency teams to the area to confirm the outbreak and begin vaccination.
Yet the suspicion that terrorists would strike more than one location "would require us to be in many, many places simultaneously," one federal planner said. "That would completely deplete our assets."
Instead of sending its staff to every corner of the country, the CDC plans to ship the vaccine and let states handle inoculation, Osterholm said. The National Pharmaceutical Stockpile, he said, "can be at any hamlet in this country in 12 hours." Officials have not said how much it would cost or how it would be paid for.
HHS has received assurance that even if air traffic were halted, as it was immediately after the Sept. 11 attacks, planes transporting vaccine would have clearance. Vaccine would be delivered in waves much the way a grocery store receives its weekly shipment of milk in batches.
The manual, which is almost 100 pages, was developed in consultation with local health officers, medical societies, the military and businesses such as UPS and Federal Express that have logistical expertise, said an adviser to Thompson. Much of its contents was based on previous large-scale vaccination programs, such as the 1995 meningitis outbreak in Mankato, Minn., in which 26,000 people were inoculated in four days.
Each state must determine where vaccination clinics would be located, who would staff them, how to counsel people on the potential risks of vaccination and, most important, how to move hundreds of thousands of people through the process calmly and quickly. Some communities might select large shopping malls or sports arenas because of parking availability; metropolitan centers might rely on buses and subways to bring people to clinics.
States will need provisions for everything from inclement weather to the person who faints at the sight of a needle, Osterholm said. "Are you going to have a line stretching 21/2 blocks in the snow or blistering heat?" he said, describing one challenge.
The guidelines urge states to address the need for bathrooms, transportation, a media strategy and a medical questionnaire, as well as how to separate and treat potential smallpox cases. They also include sample consent forms if states must administer an unlicensed vaccine. Two administration sources said they hope the vaccine soon will be re-licensed.
Although bioterrorism is a new challenge, large vaccination campaigns are not, Osterholm said. "The public health system delivers vaccine to our nation's children every day, overcoming language, transportation and financial hurdles," he noted.
Aside from an assumption that some health care workers will be vaccinated before an attack, the document does not resolve enormous questions surrounding that issue.
Last month, Thompson sent recommendations to the White House on how many people should be inoculated in advance. Although a CDC advisory panel has recommended vaccinating about 20,000 medical personnel, several administration sources said President Bush is weighing a proposal on the order of 500,000 people.
"Until a decision is made on pre-vaccination," Hauer said, "our efforts continue to focus on bioterrorism detection and response."