Smallpox immunization program stalls

GENEVA-With a national television address, high-level bipartisan backing, and his own presidential immunization, President Bush kicked off America's national smallpox vaccination campaign with great fanfare at the end of 2002. Health officials began vaccinating emergency health care workers soon after and expected to immunize about 500,000 in the first phase. The second phase of the plan was to immunize millions of firefighters, police, and other first responders over the summer.

Almost a year into the program, however, volunteers have stayed away in droves, and fewer than 40,000 medical workers have been vaccinated. D.A. Henderson, one of the leaders of the international effort to eradicate smallpox in the 1970s and now a top adviser to the Health and Human Services Department, acknowledged at a smallpox biosecurity conference here in Switzerland that the immunization program has fallen far short of expectations.

Several factors intervened to stall the immunization program for health care workers and first responders. Perhaps foremost was fear about possible side effects from the vaccine, combined with uncertainty about who would pay health claims for those effects. The war in Iraq may have boosted interest in the campaign, but the failure to find bioweapons there seemed to diminish the threat. Public health officials also had to contend with the SARS epidemic. And some health experts have questioned whether smallpox immunization was the best use of scarce resources in the first place.

Henderson, in Geneva, said that U.S. officials are now turning their focus away from a broad public vaccination effort and are trying to persuade local hospitals that immunizing their emergency health workers against smallpox is the best short-term course. The government is "trying to educate those who are the real decision makers," he said. "If I were director of a hospital, I would want a good number of my people immunized. I think there are going to be additional vaccinations."

Despite the relatively low turnout of volunteers for immunization, Homeland Security officials insist that the program has not fallen short of expectations. "We feel that we have enough inoculated individuals should an outbreak occur," said Homeland Security Department spokesman Brian Roehrkasse.

On the local level, some officials are nevertheless concerned about their ability to respond to a smallpox outbreak. The dearth of immunized medical workers and a lack of overall planning could cause confusion if an outbreak occurs, according to William Bicknell, a professor of public health at Boston University and a member of the smallpox working group in Massachusetts. "We are deceiving ourselves," Bicknell said. "Unless we get the pre-event numbers up in a major way, our hospitals are at risk." He predicted that the United States could handle a smallpox attack, but that "we'll bumble through."

Promoting smallpox vaccinations is difficult, experts say, because the disease seems like a distant and unlikely threat to a public that is already faced with a smorgasbord of terrorist bogeymen to worry about. "It is very hard to convince people [to get the vaccine], unless they think the threat is imminent," said Ken Alibek, a George Mason University professor who developed biological weapons for the Soviet Union until he defected to the United States in 1992.

By early April of this year-three months after the vaccinations had begun-the immunization program was already faltering because of concerns about the extremely rare, but potentially fatal, side effects. Participation in the program suffered further after national media attention focused on several vaccine recipients who developed heart inflammation. Subsequently, the federal government set up a program to inform health care workers about the potential dangers of the vaccine.

Rep. Richard Burr, R-N.C., is a member of the House Select Committee on Intelligence and a strong proponent of strengthening U.S. biological defenses. Determined to remove obstacles to the program's success, he sponsored legislation to provide federal compensation to those sickened by the vaccine. Advocates hoped that this initiative would alleviate a major concern and spur participation, but it probably came too late.

U.S. forces were well into Iraq by then and had not encountered any chemical or biological weapons. Well-publicized fears of an Iraqi bioterror capability might have driven early interest in the vaccination program, according to Henderson. But "getting into Iraq and not finding any of the weapons of mass destruction" killed the momentum, he said.

Some public health experts said the rush to conduct smallpox vaccinations might have been a hasty, premature decision that misdirected scarce resources. The immunization effort "was not a particularly well-developed plan and policy," said Shelley Hearne, executive director of Trust for America's Health, a nonprofit, nonpartisan public health organization based in Washington.

Instead of focusing resources on smallpox vaccinations, the United States should develop a comprehensive surveillance system to detect an outbreak, according to Hearne. She said it was wise to have the vaccine available and to conduct a low-key immunization program, but argued that a broad smallpox immunization program should never have been the focus of U.S. biological defense efforts. "Smallpox vaccination-I don't mean to belittle it, but was it the first thing? I do think it was overemphasized," Hearne said. "Is it our No. 1 priority? No." Was the rush to vaccinate ill-conceived? Henderson acknowledged in Geneva that considerable controversy exists about the scope of the smallpox threat. Alibek said he favors strong biological defenses, but this year's sudden rush to immunize verged on the "extreme," he said. "You cannot worry every single day," he contended. "You wake up in the morning worrying about smallpox ... that is no way to live."

Although the smallpox vaccination program has dropped off the public's radar screen, other public health advocates argue that the threat of a bioterror attack remains and the United States still has much planning and work ahead to ready the nation for a possible smallpox attack.

"There may be some people who choose to distance themselves from ever having said that vaccinations are needed, but the reality is that the threat is every bit as real today as it was 10 months ago," Burr said.

Even the strongest proponents of the vaccination program agree that the chances of a smallpox attack are small. They are not zero, however, and historically, the effects of a smallpox outbreak on unprepared and naive nations have been devastating. Australian scientist Frank Fenner, a leader of the original eradication effort, called smallpox "the greatest scourge of the human species." During the 20th century, smallpox is estimated to have killed 300 million people. Armed conflict, by comparison, caused 100 million deaths during the same time span.

During the Cold War, Soviet biologists took the weaponization of smallpox to new heights-or perhaps new depths-according to Henderson and Alibek. At the pinnacle of U.S.-Soviet tensions, Alibek told the Geneva conference, Moscow had smallpox-tipped ballistic missiles aimed at the United States.

Henderson said the technology and expertise developed in the Soviet Union is now spread throughout the world, making a smallpox attack all the more likely. "I'm angry," Henderson said, about being called back to government service to address a threat that was eliminated decades ago. Henderson had worked on bioterrorism issues during the Clinton administration, and Health and Human Services Secretary Tommy Thompson asked him to return to public service shortly after the September 11 terrorist attacks. "I'm angry at the Soviet Union, the people who ran that program. If they had not done that ... there wouldn't be the expertise, the technologies." Alibek concurred: "There is a threat. It still exists."

Burr said that the United States must develop a broad defense against a smallpox attack-and an array of other biological threats-by strengthening the public health infrastructure.

"We have to prepare our emergency response capabilities for anything," Burr said. "I have a very real understanding of why we need to move much further down the road for not only a comprehensive strategy on the threat of biologics, but also the need to really bring the public health system in the country into the 21st century."

Health care advocates and other lawmakers have also joined the call to prepare for a range of threats, not just smallpox. In July, the House of Representatives approved Project Bioshield, which would provide $5.6 billion to develop a range of biological defenses. The legislation is on the Senate calendar, but passage is not assured this year.

Henderson agreed that the biological defense effort should be multifaceted and said that the United States is making progress toward developing strong defenses. He acknowledged that many see the immunization effort as a failure but expressed confidence in the nation's first steps, citing newly purchased vaccine stockpiles, increased physician awareness, and improved communication within the public health community. "We're light-years away from where we were a year ago," Henderson said.

If terrorists attacked the United States with the smallpox virus, officials could quickly control the outbreak, Henderson contends. "I have a feeling we could bring it to a halt, with no cases after four to six weeks. It would not disrupt civil society," he said.

Burr and Hearne agreed that the nation is moving in the right direction. Hearne said, however, that the nation's biological defense infrastructure requires years of attention, not just a burst of funding. "Given what we've seen in the past, we've made some extraordinary progress," she said. "But a two- or three-year investment does not fix a chronic problem."