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Thirty years after conquering smallpox, Donald Henderson is fighting his old nemesis and selling a new immunization program to skeptical health care workers.

D

onald A. Henderson is angry. He resents being put back in the position of fighting an enemy he helped eliminate 30 years ago. He's upset that the realities of the post-Sept. 11 world have again thrust him into battle with a familiar-and deadly-foe.

And who can blame him? For 11 years, starting in 1966, Henderson led an international effort to eradicate smallpox, one of the most deadly viruses in human history. He was the chief architect of the World Health Organization's program to vaccinate groups of people ranging from school children in the United States to entire tribes in the most remote and impoverished parts of the Third World. It was a mammoth undertaking. Nearly 15 million people annually were infected with smallpox. Two million people died each year, and millions more were left disfigured-some of them blind. If trends had continued, more than 350 million people would have fallen ill, with roughly 40 million dying by the end of the 20th century, according to WHO statistics. The death toll equates to the entire population of Spain or South Africa.

But thanks largely to Henderson's efforts, the eradication campaign was a success. The United States stopped routine smallpox vaccinations in 1972. The last known case of the disease was found in Somalia in 1977. And, in 1980, the WHO officially declared smallpox wiped out. Henderson had reached the pinnacle of his profession.

Fast-forward 21 years. Immediately after Sept. 11, 2001, political leaders became fearful of biological attacks. The prospect that terrorists would get their hands on laboratory-born versions of smallpox and unleash them on the public topped their list of concerns. Five days after the attacks, Secretary of Health and Human Services Tommy Thompson called on Henderson to help formulate a biodefense preparedness strategy. Among his chief responsibilities was developing a vaccination program to defend against his old nemesis, smallpox.

"It's one of those things, I would have to say, that I resent having to be doing," the 74-year old Henderson said during a recent interview in his sparsely decorated office at HHS headquarters. "Simply from the standpoint of having invested so much-as many people did-in eradicating the disease and then stopping vaccinations, because vaccination does come with a certain amount of complications. One hates to return to a time when we are looking at vaccination again and looking at the possibility of smallpox and having to invest money in this."

Henderson, along with other public health advisers and officials from the Centers for Disease Control and Prevention, spent roughly a year developing a new smallpox vaccination program. It officially kicked off this January. The plan, which is being run out of CDC headquarters in Atlanta, calls for creating a volunteer army of inoculated public health workers, including nurses, doctors, firefighters, police officers and emergency personnel. Protected from the virus, they would be able to swoop into areas of outbreak and immediately begin vaccinating people. Military personnel would be vaccinated as well-in fact, their vaccinations are mandatory.

Administration officials said that as many as 450,000 doctors and nurses could be eligible for the vaccine. The first phase was supposed to take a month. Roughly 10 million other people-including other health care workers, emergency personnel, firefighters and police officers-were identified as potential candidates for vaccination in the second phase, which is slated to roll out this summer. At least that was the plan.

But by early June, only 36,000 health care workers had been vaccinated. HHS officials readily admit that the numbers are not where they would like them to be. "It is going slower than we would have liked," says Jerome Hauer, head of public health preparedness at HHS. "It has hit some obstacles."

Several health workers who received the vaccine later became sick, and three died. As of early June, it was unclear if the illnesses and deaths were related to the vaccine. The low rate of participation and the medical complications have spurred a debate not only about the program's merits, but also about HHS' effectiveness in deploying a wide-scale vaccination program should there be a bioterrorist attack of any kind.

Public health officials are calling on the CDC to re-evaluate the smallpox program. From the outset, the influential Institute of Medicine (IOM), a wing of the National Academy of Sciences that advises the government on health policy, has called for a pause between phase one and phase two. The institute wants the CDC to study the effects of the vaccine on health workers.

Officials at the IOM reiterated their position in a strongly worded May 23 letter to CDC Director Julie Gerberding, suggesting that a pause would help the CDC evaluate progress to date and determine next steps. The IOM acknowledged that doing so comes with some risk-such as further slowing momentum and leaving some areas vulnerable in the event of an outbreak.Even Henderson, who has scaled back his time at HHS and returned to academia, says it would be a good idea to gather data before launching phase two.

Hauer bristles at the notion. "We are not pausing," he says. "IOM has its opinions. We certainly understand that. It doesn't necessarily mean that we follow them."

OLD FOES

Fears of a smallpox attack are not new. Even after the WHO declared the disease eradicated, experts worried that a rogue nation could introduce it to an unsuspecting andill-prepared population. Strands of the virus were known to exist in two laboratories-one at the CDC in Atlanta, the other at the Vector Institute, a Russian government research facility in Siberia.

In the late 1990s, evidence emerged showing that the former Soviet Union had stockpiled large quantities of smallpox. After the breakup of the Soviet Union, public health officials were concerned that scientists fleeing Russia not only knew how to develop smallpox, but also may have smuggled samples out of the country. And there were indications that countries such as North Korea and Iraq had stockpiled the virus.

From his perch as dean of the Johns Hopkins University School of Hygiene and Public Health and later as an assistant secretary at HHS, Henderson spent much of the 1980s and 1990s arguing that the laboratory forms of the virus should be eliminated. "What we thought was, if the two labs that were known to have had this destroyed it, there could be a resolution in the WHO, or somewhere in the United Nations, that said any scientist, laboratory or country found to have smallpox virus after a certain date would be guilty of crimes against humanity or something of that nature," he says. "Well, that wouldn't guarantee compliance, but it would put a lot of pressure on countries to comply."

Henderson lost the battle. Experts on geopolitics argued that getting rid of the known laboratory forms of smallpox would leave the world vulnerable to an attack. Without them, new vaccines couldn't be generated quickly. A resolution never came forward within the United Nations.

THE NUMBERS GAME

On Jan. 24, 2003, four doctors in Connecticut became the first civilians in the United States to receive the smallpox vaccine since 1972. It was the start of what administration officials had hoped would be a successful-and quick-vaccination campaign. It's been anything but.

For starters, the needed number of vaccinated health care workers has never been certain. As the plan unfolded during the summer of 2002, the CDC's Advisory Committee on Immunization Practices (ACIP) considered recommending 15,000 to 20,000 workers be included in the first phase and that single smallpox response centers be created to serve different geographic areas. But "we quickly found that hospitals didn't want to be the only smallpox response center in a particular area," says Brian Strom, a professor of epidemiology at the University of Pennsylvania who is heading up the IOM's assessment of the smallpox program. "They thought it would deter other patients from coming in. So the plan evolved to response teams for every hospital."

CDC asked state public health departments to determine how many people it would take to create a larger cadre of vaccinated nurses and doctors. Henderson then estimated the total at 500,000. But he acknowledges the number was "a guess."

"Say you have 100 hospitals in a state," Henderson says. "You have three shifts, seven days a week. How many people could potentially be exposed in an emergency room? It's a very difficult thing to calculate the exact number." CDC later reduced its estimate to 450,000.

Soon the news media were reporting that the CDC hoped to reach 450,000 people within a month. Hauer claims that was never the intention, especially since the program is voluntary. Rather, the idea was to educate as many health care workers as possible and eventually have a substantial number of them take the vaccine. "I don't think we ever thought that we could reach 500,000," he says. "We left it up to the states to determine the adequate number of people for their individual environments."

The IOM, in its May 23 letter, argues that it is "imperative" that state and national officials set a number before "continuing to expose individuals to a vaccine."

RISKY PROPOSITION

The failure to attract a large number of volunteers to take the vaccine can be traced to several factors. First and foremost is the fact that the smallpox vaccine is live virus. Anyone inoculated is exposed to a virus called vaccinia, which causes cowpox, a relative of smallpox. People with healthy immune systems can ward off cowpox in a matter of days, building a defense against smallpox in the process. Those with weaker immune systems can become ill, even die. Studies from the 1960s show that 15 to 49 people out of every million receiving the smallpox vaccine for the first time will develop serious illnesses. Two will die.

Henderson says HHS inititally did a poor job of educating the health care community about the smallpox program and the potential complications of the vaccine. Few of today's medical professionals were involved in the last vaccination program nearly 30 years ago. "We talked about vaccination and there was a thought among many people that this was just like the flu shot," he says. "We thought, 'Wait a minute, this isn't like the flu shot.' This vaccine causes some very nasty reactions."

As the program has evolved, the CDC has improved its information campaign, according to Henderson. But he says it must continue to evolve as the program rolls out to a broader group of people.

Beyond the risks associated with the vaccine, some health care officials say the low turnout can be attributed to the lack of a credible threat. For much of the program's history, the word coming from CDC and HHS has been that the threat of a smallpox outbreak is minimal. William Schaffner, head of preventive medicine at Vanderbilt University Medical Center in Nashville, Tenn., and a liaison to the CDC immunization task force, recalls that early on, Henderson told the panel that the threat of an attack using smallpox as a weapon, while not zero, was very low. Henderson stands by that statement. But he is quick to point out that should an outbreak occur, more than 80 percent of the population is susceptible to contracting the disease.

"We have a dangerous vaccine that, while causing protection, causes serious illness. If we are going to use it, why?" Schaffner asks. "What are the benefits? If the risk [of a smallpox attack] is very low, the equation doesn't come out in favor of vaccination, at least in the minds of many people." In fact, Vanderbilt's medical board ultimately decided not to participate in the program. State health officials assured them that the vaccine could be made available within 24 hours in the event of an outbreak.

Perhaps the biggest stumbling block to widespread vaccinations has been money. Or, more precisely, compensation for health care workers. When HHS launched the program in January, it did not include a compensation package for workers who might become ill, or for their families in cases where a worker died as a result of taking the vaccine. Powerful labor unions, such as the American Nurses Association and the Service Employees International Union, opposed any smallpox vaccination program that did not include compensation.

After several months, Congress passed compensation legislation, which President Bush signed in mid-April. Under the law, volunteers who are permanently and completely disabled will receive up to $50,000 annually in lost wages, with no lifetime cap. Those who are temporarily or partially disabled will receive the same annual compensation, with a $262,100 lifetime limit. Widowed spouses will receive $262,000. Dependents of those who are killed can receive $262,000 in a lump sum, or $50,000 annually until they are 18.

MOVING FORWARD

Despite the difficulty in recruiting volunteers to take the vaccine, public health officials praise other aspects of the smallpox program. In particular, they say it has gone a long way toward improving communication among public health officials at all levels-CDC, state health departments, hospitals and emergency responders-and aiding overall public health preparedness. Henderson says it has not only forced health care officials to focus on bioterrorism, but also has put in place procedures that will help them respond quickly to other crises, such as the SARS epidemic.

John Agwunobi, Florida's secretary of health, agrees. His state has been among the most aggressive in implementing the smallpox vaccination program. As of early June, 3,600 health care workers in the state had been vaccinated. He plans to roll out phase two this summer. But the goal has never been strictly about numbers, Agwunobi says. "Our target is to reach out to the people being offered the vaccine," he says. "We went into 200 hospitals and reached all the staffs. We told them, 'Here is the threat, here is the vaccine, and here is what we know about it. Here are the risks." The health department will use the same approach for emergency responders. "Our ultimate goal is to reach every first responder in Florida with the information," Agwunobi says. "When I'm certain we are able to do that, on a one-on-one basis, we will deem it complete."

Agwunobi says the information network created under the smallpox program is now a vital part of the state's public health infrastructure. "We are seeing a degree of communication that is going up and down the chain like we haven't seen in the past," he says. "This is happening now. Quickly. I love this. I'm seeing action develop out of ideas."