December 6, 2002 | Backgrounder on Department of Homeland Security
Vaccinating the American public against smallpox is no longer just a public health issue. In light of a possible war with Iraq and recent statements attributed to al-Qaeda leader Osama bin Laden, it has become a national security matter. Mounting concerns about new terrorist attacks, including biological attacks on American civilians, have intensified the debate among policymakers and public health officials over how best to prepare for a smallpox attack, either with preemptive or post-attack vaccinations. Even a localized attack on non-immunized Americans could result in the deaths of a million or more people nationally.1 A comprehensive strategy is needed.
From a national security perspective, preemptive but voluntary smallpox vaccinations for the general public--along with a more comprehensive vaccination program for military personnel and critical first responders--makes the most sense. Voluntary vaccinations would help reduce the spread of the disease were it used as a weapon, improve the ability of the public health sector to treat those infected from an attack, reduce panic during a crisis, and provide a reasonable deterrent to the use of smallpox by terrorists.
While the vaccine does pose some risks, these are offset by the growing threat and the government's responsibility to ensure Americans' well-being. Moreover, compared with a mandatory vaccination regime, a voluntary vaccination program would respect an individual's right to choose whether or not to absorb the risks of inoculation.
Smallpox is an extremely contagious disease once a victim begins to show symptoms--usually seven to 17 days after exposure. Historically, it has a fatality rate of approximately 30 percent. An attack against an unprotected population, therefore, could spread rapidly and have dire consequences. However, statistics also predict that, absent an attack, approximately 300 people would die in a mass inoculation program.2
Knowing this, policymakers must decide whether to vaccinate everyone before an attack or wait until after an attack to begin the vaccinations. While some officials are considering a mandatory inoculation program, a voluntary preemptive program that respects the right of each person to decide whether to absorb the risk associated with the vaccine rather than the risk of contracting smallpox would be far more effective. It would promote national preparedness by reducing the numbers that would need to be vaccinated should an attack occur and also address important liability concerns that could discourage the vaccine's manufacturers.
In 1980, the World Health Organization (WHO) declared that smallpox had been eradicated as a naturally occurring disease, with the last known case having occurred in Somalia in 1977.3 Currently, there are only two WHO-approved and inspected repositories of the live virus: the Centers for Disease Control and Prevention (CDC) in Atlanta and Vector Laboratories in Russia. All other nations holding stores of the virus were directed to destroy them or send them to one of these facilitates.
Nevertheless, clandestine stockpiles are believed to exist in states such as Iraq and Iran that have worrisome ties to terrorist organizations.4 Further, the former Soviet Union is suspected of experimenting with weaponizing the smallpox virus during the 1980s in violation of international agreements.5 While those stocks are believed to have been destroyed, experience has shown that Soviet (and early post-Soviet Russian) security at its weapons of mass destruction (WMD) research and storage facilities was questionable at best; stocks of the virus could have been smuggled out.6 As a result, it is very difficult to determine the extent of the threat today.
Though the likelihood of a smallpox attack and the merits of different vaccination strategies are certainly open to debate, the potential consequences of an attack and the vulnerability of the U.S. population to an outbreak are not. American civilians have not been vaccinated against smallpox since 1972, and the Department of Defense stopped vaccinating troops in the 1980s (a new military vaccination program is being reviewed by the White House). As a result, those under 30 years of age--approximately 42 percent of the American population7--are not likely to have been vaccinated; they would be highly susceptible to contracting smallpox in the event of an attack.
Added to this concern is the fact that it is not known whether those vaccinated before 1972 retain any immunity to the disease. The lack of immunity would make the general population grossly vulnerable to the disease.
The smallpox vaccine also carries significant risks. Experience with the vaccination program in the United States prior to 1972 indicates that approximately one in every 1 million first-time recipients is likely to die from complications.8 Therefore, a complete vaccination of the U.S. population could cost 300 lives. Estimates of how many people would suffer from serious complications but not die vary dramatically from one in every 8,000 to one in every 67,000.9
Opponents of vaccinating the general population in advance of an attack include the American Medical Association and other groups in the medical community. They typically cite two reasons for their opposition: the unknown nature of the threat and the risks associated with the vaccine. The logic behind their decision is twofold: (1) a belief that, without a better assessment of the threat, the potential loss of life (even if only a tiny fraction of the population) outweighs the benefits of vaccination and (2) concerns over the legal liability of the administering physicians as the distributors of the vaccine. They suggest limiting pre-incident vaccination to the military and those first responders who choose to receive it. The general population would be left vulnerable and would not receive treatment until after an attack.
But ignoring national security concerns and choosing a vaccination strategy based merely on public health concerns would leave the United States defenseless against an attack. Terrorists such as al-Qaeda operatives will look for any deficiencies in domestic preparedness and take advantage of them.
Since the terrorist and anthrax attacks of 2001, the CDC and its parent agency, the U.S. Department of Health and Human Services, have undertaken significant efforts to ensure that by the end of this year, there will be enough smallpox vaccine available to inoculate every American. The policy procedure for implementing this objective is developing more slowly.
Initially, the CDC planned to rely only on a strategy known as ring vaccination, which helped to eliminate the natural occurrence of smallpox in the 1960s and 1970s. This strategy relies on tracking down all those who came into contact with the initial case (or cases) and vaccinating them within four days of the initial exposure.
Such an approach is poorly suited to combating a terrorist attack using smallpox, since hundreds or thousands of people would be infected during the initial release of the virus. In America's highly mobile society, those initially infected are likely to spread the disease over a very wide geographic area. Tracking down all those who have had contact with the original infected group would be a huge undertaking. Yale University Professor Edward Kaplan is among those who are pessimistic about using the ring vaccination strategy. Concerning the CDC plan, he said it would be "a fantasy to believe that the control of small natural outbreaks provides guidance for large bioterrorist attacks."10
Further, much of the vital four-day window in which post-exposure vaccination is known to be effective in preventing illness would be absorbed by logistics. As recently as June of this year, the CDC's Advisory Committee on Immunization Practices (ACIP), which developed the ring smallpox vaccination strategy, noted that only one lab in the nation (the CDC in Atlanta) is capable of confirming a case of smallpox and that such a determination can take between eight and 24 hours.11 Moreover, it will take 12 to 24 hours for the vaccine in the National Pharmaceutical Stockpile to reach its distribution points.12 Even if a first-generation case was sent promptly to the CDC in Atlanta for review, much of that crucial four-day vaccination window would be lost, and the ability to prevent the onslaught of second-generation cases would be less certain.
The CDC recently revised its strategy, noting that it may need to undertake regional or national voluntary mass vaccinations in the event of an attack.13 In fact, the ACIP noted that the ring vaccination strategy would need to be supplemented occasionally by post-incident voluntary vaccinations during large outbreaks in order to eradicate the disease.14 The CDC recognizes that terrorists will likely target large numbers of people. It is planning to allow first responders and public health workers to receive the vaccine on a voluntary basis, and it has reserved 1 million doses for the Defense Department's draft vaccination program.
Making the smallpox vaccine available to those who will be instrumental in combating an outbreak and those responsible for fighting the international war on terrorism is a good first step. But CDC's reluctance to undertake mass vaccinations in advance of an attack is a mistake.15 CDC's calculation fails to consider that, after a confirmed smallpox attack, the health officials would have to vaccinate at least a portion of the population in a crisis.
As the nation saw during the anthrax attack, in a crisis, people are likely to demand access to treatment whether they have been exposed to an agent or not. Since smallpox historically has proven a much more deadly disease than anthrax, fear during a smallpox attack may prove much greater than anything witnessed last fall. Not only would the crisis environment present challenges and risks in distribution of the vaccine, but all of the risks associated with the vaccine also could be amplified. The need for quick action would not leave sufficient time for screening patients who are at risk for complications or allow medical professionals to focus adequately on follow-up care.
The CDC has published guidelines recommending how local public health officials should handle these complications.16 But while this is an important step in ensuring a well-managed response, it leaves the locality to decide for itself how best to handle security.17The additional challenges of inoculating people during a crisis would be greatly reduced through a system of voluntary vaccination.
After a smallpox attack, the difficulties associated with the ring vaccination program or CDC's crisis management approach to mass vaccinations could be greatly reduced if even a portion of those in the target area did not need to be vaccinated. Ensuring some degree of prior immunity among the population at large through preemptive and voluntary vaccinations would boost the public health sector's ability to stop the spread of the disease, since fewer people would be likely to contract and spread it. This also would mitigate the national (and potentially international) consequences of an attack.
Moreover, a voluntary vaccination program implemented during a non-crisis time would enable doctors to take more exacting measures. They would be better able to screen out patients at high risk for complications from the vaccine--for example, people with weakened immune systems or a history of skin problems, pregnant women, or children under one year of age. With the number of people who need vaccinations after an attack reduced, the risk of chaos also would fall, with fewer people rushing to hospitals to be treated, and the availability of adequate outpatient and follow-up care would rise.
The CDC should begin developing standards for voluntary vaccinations with the intent of instituting that strategy early in the new year instead of focusing on how to vaccinate potentially millions of Americans after an attack. The CDC also should begin drafting a set of guidelines for distributing the vaccine to hospitals nationwide and for screening out prospective recipients at high risk of experiencing complications. And it should begin drafting standards for post-procedure care to reduce the likelihood of complications or further transmission.
The CDC also should develop an educational program on the risks associated with smallpox and the vaccine. This program should not encourage or discourage vaccination, but simply lay out the facts clearly so that each American can make an educated decision. The administering physicians should inform potential recipients of the risks involved, consistent with CDC's guidelines, and those who agree to the inoculation should sign a waiver noting that they understand the risks and accept responsibility for potential side effects.
The Department of Defense reportedly plans to vaccinate approximately 500,000 of its 1.4 million active duty personnel, beginning with medical staff and followed by those troops likely to be deployed to the Middle East.18 Procedures for immunizing these frontline troops should continue as planned. The Defense Department should also plan to expand this program to vital National Guard personnel who would likely be called upon to assist civil authorities during a domestic smallpox attack.
Consideration must also be given to the fact that vulnerability among the nation's first responders directly affects the country's ability to respond to an attack. These professionals are likely to find themselves in close and more frequent contact with infected people in the event of attack. Every community, therefore, will need to have some first responders, particularly health care workers, who are immune to the disease already and can operate in an environment where the virus is abundant (such as secure areas of a hospital or other locations dedicated to the care of smallpox victims). But many first responder jobs will also be required in lower-risk areas. Consequently, a federally mandated, universal program for vaccinating all first responders, while beneficial, may not be necessary.
Vaccination standards for first responders should therefore be left up to state and local agencies. The federal government should encourage the states and communities to vaccinate personnel deemed essential to the community's smallpox response plan, but it should allow the local authorities to determine who those personnel are and how to implement the vaccination requirement. First responders who are not essential to a community's smallpox response plan could participate in a voluntary program; they should not be required to be immunized as a condition of their first-responder position.
The federal government should take action now to address the potential liability concerns of a vaccination program, but it should not assume responsibility for health decisions made by individuals. Public education will be crucial not only to reducing America's susceptibility to a smallpox attack, but also to addressing the liability concerns properly.
The Food and Drug Administration (FDA) has never approved the current supply of smallpox vaccine. Though the vaccine's risks and benefits are well-documented from its long use prior to 1972, it is currently being distributed under Investigational New Drug (IND) protocols designed to determine whether it is reasonably safe for initial use in humans. Nonetheless, in a nation where trial attorneys view litigation as a mechanism for social activism, it is likely that financial compensation will be sought by some of those who accept the vaccine and later become ill or by families of the small number of people who die as a result of complications. In a voluntary vaccination program that includes pretreatment education about the known risks and the degree of uncertainty of outcome, primary responsibility for the decision to take advantage of the smallpox vaccine should lie with the individuals who seek it.
Admittedly, administering physicians should be required to educate each individual about the vaccine's risks and take every reasonable precaution to screen out those who are particularly vulnerable. And medical professionals should be held liable for gross negligence in the process of educating, screening, administering vaccines, or providing outpatient care. The federal government should enforce guidelines related to the program, but the government, hospitals, doctors, and companies that manufacture the vaccine should not be held liable for the vaccine's known or well-established risks in a voluntary program that publicizes those risks. Congress should ensure that developers of vaccines and the administering doctors have protection from liability in this regard.
Governor Tom Ridge, the Secretary of Homeland Security designee, reportedly prefers to address liability concerns with a system that would compensate those who suffer from any complications. While this approach could be modeled on elements of the National Vaccine Injury Compensation Program,19 that program is designed to compensate those who suffer complications from childhood vaccines related to active and known diseases in the population today. Many of these vaccinations are now required before a child can enter public school. To receive compensation, a patient must prove that the illness is the result of a vaccination, and compensation is limited.20 Limiting payments is better than allowing unfettered legal action, but little else about this program applies to a smallpox terrorist attack or mass vaccination program.
Smallpox is not a known disease, and inoculating the entire population to avert the effects of a feared terrorist attack would expose far more people to the possibility of complications than do the current inoculations for other known diseases. A voluntary program using vaccines with well-established risks that allows each person to decide whether to expose himself or herself to those risks or remain at risk of contracting the disease itself in a bioterrorist attack is a better approach. To defer some of the potential costs of adverse reactions to the vaccine, people who choose the inoculation should seek health insurance to cover that risk.
To protect suppliers of future vaccines, the Secretary of Homeland Security should designate all existing formulas of the smallpox vaccine as "qualified antiterrorism technologies" under the Support Anti-Terrorism by Fostering Effective Technologies Act of 2002 (the SAFETY Act).21 The act allows the Secretary of Homeland Security to limit damages that a plaintiff can seek against the producer of a designated antiterrorism technology.
To be designated as a qualified antiterrorism technology, the vaccine must meet seven criteria: prior use by the federal government or demonstrated utility and effectiveness; availability for immediate deployment; potentially large or unquantifiable liability risk; likelihood that it will not be deployed unless protected; risk if not deployed; other means of reducing risk have been studied; and it is effective in defending against terrorism. A vaccine to protect the general population from a particularly dangerous agent such as smallpox is a good candidate for the qualified antiterrorism technology designation.
A completely vaccinated population, of course, would offer the United States strategic immunity from smallpox attacks. Vice President Richard Cheney reportedly favors this approach, and the President is currently weighing this option.22 While the federal government could mandate a nationwide smallpox vaccination program on the grounds that is in the national security interest of the United States, absent a known threat, such action is probably unnecessary and could raise complicated liability question.
The federal government's responsibility rests in developing a vaccination program that protects the security and safety of the nation. The CDC expects to have enough vaccine for every American by the end of 2003. Combined with a well-prepared public health sector and a clear post-incident vaccination strategy, a voluntary preemptive vaccination program would mitigate the consequences of a terrorist attack by limiting the spread of the disease and reducing panic without trampling on the freedom of Americans to decide for themselves how best to protect themselves and their families. There are significant risks with the smallpox vaccine, but the risk of bioterrorism is rising, and Americans should be allowed to weigh all those risks as they relate to their own safety.
From a national security perspective, a preemptive but voluntary smallpox vaccination program for the general public in addition to a more comprehensive vaccination of military personnel and first responders makes sense. Preemptive vaccinations administered in this manner would reduce the spread of the disease, improve the public health sector's ability to treat those at risk or infected after an attack, reduce panic and potential chaos during a crisis, and provide a reasonable deterrent to the use of smallpox by terrorists.
While the vaccine does pose some risk to Americans, these risks are offset by the growing threat of a smallpox attack and the government's need to protect the nation and the well-being of the population at large. In contrast to a mandatory vaccination regime, a voluntary vaccination program also respects an individual's right to choose.
--Michael Scardaville is Policy Analyst for Homeland Security in the Kathryn and Shelby Cullom Davis Institute for International Studies at The Heritage Foundation.
1. Estimate based on scenarios such as the "Dark Winter" war game conducted in June 2001 by the Johns Hopkins Center for Civilian Biodefense, Anser Institute for Homeland Security, Center for Strategic and International Studies, and Oklahoma City National Memorial. See http://www.hopkins-biodefense.org/DARK%20WINTER.pdf.
19. See, for example, Veronique de Rugy and Charles V. Pena, "Responding to the Threat of Smallpox Bioterrorism: An Ounce of Prevention Is Best Approach," Cato Institute Policy Analysis, April 18, 2002, pp. 11-12. That program was created under the National Childhood Vaccine Act of 1986 (P.L. 99-660).