The Smallpox Vaccination Campaign of 2003: Why Did It Fail and What Are the Lessons for Bioterrorism Preparedness?

• Author: Edward P. Richards; Katharine C. Rathbun; Jay Gold
• Position: JD, MPH; Director, Program in Law, Science, and Public Health, Harvey A. Peltier Professor of Law
• Pages: 851-904

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Edward P. Richards, JD, MPH; Director, Program in Law, Science, and Public Health, Harvey A. Peltier Professor of Law, Paul M. Hebert Law Center, Louisiana State University.

Katharine C. Rathbun, MD, MPH; Ochsner Clinic Foundation, Baton Rouge, Louisiana.

Jay Gold, JD, MPH, MD; MetaStar, Inc.

IIntroduction

On December 13, 2002, the White House announced a plan to vaccinate active duty military personnel and certain civilian hospital, health care, and emergency services workers against smallpox.¹² This announcement was accompanied by a Smallpox Vaccination FAQ.³ The goal was to vaccinate 500,000 military personnel as soon as possible, and then to vaccinate 500,000 civilians within a few weeks. There were no specific plans to vaccinate the general population, but there was discussion about making the smallpox vaccine available to the general public in 2004. President Bush was immunized first, with no reported ill effects.⁴

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By January 2004, 578,286 military personnel were vaccinated.⁵During the same period, only 39,213 civilian health-care and public health workers were vaccinated, less than ten percent of the original goal.⁶ This article analyzes why the civilian smallpox vaccination campaign failed, the impact of this failure, and what it should teach us about future vaccination campaigns for smallpox and other bioterrorism agents. Some of the reasons for failure could have been averted with better planning and legislation, but others are intrinsic to the United States's medical and legal systems. Addressing these intrinsic problems demands fundamental modifications in the plans for bioterrorism preparedness.

This article does not discuss the control of a smallpox outbreak, beyond the use of smallpox vaccinations. Control measures would include stopping all transportation in and out of the affected area, identifying all cases, persons in contact with those cases or in contact with contacts of those cases, vaccinating and isolating the contacts, and trying to preserve social order and infrastructure in the affected region. Such measures would require military intervention as discussed in other papers in this symposium issue. It is possible that we would see the breakdown of civil order and imposition of martial law. The authors believe that such measures will be nearly impossible to carry out because they pose difficult moral and ethical dilemmas such as whether to shoot the soccer mom with the minivan full of kids trying to get out of the city. As a result, the authors stress the importance of a workable vaccination program which can stop the epidemic even if draconian control measures fail.

This article originated in the Smallpox Vaccine Injury and Legal Guide,⁷ an online analysis of the medical and legal issues posed by Page853 the smallpox vaccine campaign that was updated as the campaign progressed. Through the guide and discussions with health care instutions, unions, health departments, and reporters,⁸ Professor Richards and Dr. Rathbun helped many health care organizations tailor their response to the smallpox vaccine campaign.

IIWhat Were The Core Problems With The Smallpox Vaccination Plan?

Most of the opposition to the civilian smallpox vaccination plan came from health care institutions. Their concerns revolved around six issues that the government failed to address properly when the plan was announced. While some of these issues have been clarified since the plan ended, some have yet to be satisfactorily resolved. The opposition of the health care institutions to the plan effectively stopped it, leaving open the question of whether the individuals who were the target of the plan would have cooperated if their institutions had supported the plan. This article analyzes the following six queries as they arose during the rollout of the smallpox vaccination plan, considering the extent to which they have been resolved:

1) What is the real complication rate for smallpox vaccine, and who is at greatest risk for complications?

2) Is the vaccine being administered in a safe manner?

3) Will worker's compensation cover worker injuries and lost time?

4) Are all members of the health care team protected by the legal immunity provisions of the Homeland Security Act?

5) How will persons injured by the vaccine be compensated?

6) Is this plan epidemiologically sound? In other words, does it improve smallpox preparedness sufficiently to be worth the risks? If not, is there a better alternative?

While the smallpox vaccination plan was in effect, the authors did not take a position on whether health care workers should participate. Such workers were advised to read the CDC's Smallpox Vaccination Page854 and Adverse Reactions: Guidance for Clinicians,⁹ the Recommendations of the Advisory Committee on Immunization Practices (ACIP)-;Smallpox,¹⁰ and the label¹¹ for the vaccine, which contains information that has been left out of the CDC and ACIP materials. Health care employers were advised to set up surveillance systems to assure that they are aware of every vaccinated employee so that they can monitor the employee's vaccine sore and control the exposure of at-risk patients. They were also advised to identify all independent contractors in their system who might have contact with vaccinated persons or who otherwise might be at risk for vaccine- related injuries. These contractors needed to sign agency agreements with the employer or the local health department to try to bring them under the immunity umbrella of the Homeland Security Act. When most health care employers considered the uncertainties in the plan along with the medical and legal risks, they decided not to participate.

IIISmallpox As A Bioterrorism Agent

The risk of any smallpox vaccination plans must be evaluated in the context of the risk of a smallpox outbreak. Smallpox is a highly contagious viral disease characterized by fever and an eruption of vesicles and pustules, which kills five to thirty percent of infected Page855 persons.¹² Infected persons who survive are often terribly disfigured by the smallpox scars and many are blinded by the disease.¹³ It is spread through close contact when infected persons cough out particles of the virus (variola major) from sores in their mouths and lungs.¹⁴ These particles can be inhaled, but are more commonly picked up as tiny dried droplets in the environment and inadvertently ingested or rubbed into the eyes.¹⁵ The period during which an infected person can spread the infection is about three weeks, from just prior to the appearance of the rash until the last scab disappears.¹⁶About half of those exposed to the virus develop the infection.¹⁷There is an incubation period of seven to nineteen days (mean: twelve days) during which the infected person exhibits no symptoms.¹⁸

Once infected, a person always goes on to develop symptoms, but the severity of the cases vary from mild illness to rapid death.¹⁹Persons who recover from smallpox infection have a long-lasting immunity.²⁰

Smallpox infects only human beings. It has no animal reservoirs and persists in the environment for only a short period, except when properly prepared in a laboratory. Smallpox must be actively infecting a human population to survive. It did not exist until human beings reached a high enough density that it could spread from community to community, often not returning until there was a new generation of children or young adults who were susceptible to the disease.²¹

Since smallpox has no animal hosts and is not persistent in the environment, it would be eradicated if at any point in time there were no human beings infected. This became a theoretical possibility in the 1951 when Collier developed a freeze-dried smallpox vaccine Page856 that could be stored at room temperature and thus could be easily transported to remote locations.²² A Western Hemisphere smallpox eradication program was started by the Pan American Sanitary Organization in 1950.²³ At the suggestion of the Soviet Union, the World Health Organization began a worldwide eradication program in 1967.²⁴ This program combined intensive case finding and contract tracing-;looking for persons infected with or exposed to smallpox-;with mandatory vaccinations for all exposed persons. On October 26, 1977, the last known naturally occurring smallpox case was recorded in Somalia. In 1980, the WHO declared that smallpox had been eradicated. The United States ended routine smallpox vaccinations in 1972, and they were not routinely given anywhere after 1983.²⁵

Before eradication, many laboratories maintained stocks of the virus for research purposes. After eradication, a laboratory accident that led to a smallpox death reminded the world that these laboratory stocks of virus had the potential to reintroduce smallpox into the world.²⁶ All the remaining stocks were destroyed, with the exception of stocks maintained by the CDC in Atlanta and the Soviet Union. There was an ongoing debate over destroying these remaining stocks, until a defector who ran the Soviet Union's biological...