Terror and Triage: Prioritizing Access to Mass Smallpox Vaccination

• Publication year: 2001

36 Creighton L. Rev. 359. TERROR AND TRIAGE: PRIORITIZING ACCESS TO MASS SMALLPOX VACCINATION

Creighton Law Review

Vol. 36

ROSS D. SILVERMAN(fn*) THOMAS MAY(fn**)

ABSTRACT

In response to the threat of a smallpox attack on the United States, the Centers for Disease Control and Prevention ("CDC") recommended the establishment of smallpox clinics designed to distribute a vaccine to the entire U.S. population in a ten day period. However, a number of potential obstacles raise questions about the feasibility of this plan. What is needed is a plan that applies principles of triage to smallpox vaccine distribution following a bioterrorism attack. Only in this way can those most vulnerable - the previously unvaccinated - be protected from a significantly increased risk due to delays that might arise in executing the CDC plan.

INTRODUCTION

In the wake of the bioterror attacks of October 2001, the visibility of smallpox as a potential biological weapon has lead to government actions designed to prepare for potential attacks using this agent. In December 2001, the Department of Health and Human Services allocated $428 million for the development of 155 million smallpox vaccine doses, and studies are being conducted concerning the viability of diluting our existing stockpiles of the smallpox vaccine so that greater numbers of people can be vaccinated in the event of an outbreak.(fn1) These efforts are intended to increase U.S. smallpox vaccination stockpiles to 286 million by the end of 2002 (enough to cover every U.S. citizen). Distribution of this stockpile, however, remains controversial.

The Centers for Disease Control and Prevention ("CDC"), in their initial interim smallpox response plan and guidelines, recommended a ring vaccination and monitoring approach coupled with identification of priority "high risk" groups as the preferred tactic to address a smallpox outbreak. Under a "ring vaccination" or "search and containment" strategy, known and suspected cases are isolated from society, and those who have come in contact with such cases are traced, vaccinated and kept under close surveillance. Through this strategy, a "ring" of vaccinated individuals is created to surround the infected, thereby impeding further spread of the disease.(fn2) However, doubts about the effectiveness of this plan, along with public calls for access to vaccination, have forced the CDC to reevaluate its reliance on the ring vaccination.

Bush administration plans have, at times, called for mass voluntary vaccination of the general public prior to any bioterror event, although such mass vaccination would likely not be carried out until 2004 at the earliest, and more recent administration announcements indicate the administration is leaning toward a more limited availability of the vaccine.(fn3) We have argued elsewhere that mass vaccination of the general public, pre-event, is unwise. One of the primary reasons for this lies in the low probability that terrorists have access to, and the ability to effectively deliver, this particular biological weapon. Nonetheless, the threat is real. While the low probability just described makes it unwise to expose the public to the risks of smallpox vaccination (mass vaccination itself would likely result in 350-500 deaths, and other serious side-effects, without any overt terrorist act whatsoever), planning for post-event vaccination is wise regardless of pre-event vaccination policy. In this context, recent studies on the need to target vaccination for maximum effectiveness should be incorporated into smallpox response plans.(fn4)

In September 2002, the initial CDC response plan was supplemented with guidelines for conducting a mass vaccination of the entire U.S. population in a ten day period. These new guidelines are to be applauded for reasons we discuss below. However, serious deficiencies remain. Foremost among these is the lack of clear triage plans that prioritize access to a mass vaccination in the event of a terror-related outbreak. Any terror-related outbreak of smallpox will almost surely result in public panic and demand for vaccination that will strain the public health infrastructure. There is a need, then, to devise criteria for the orderly administration of the vaccine even under the best scenario. It is in the hope of contributing to the development of such plans that we offer the ideas and observations below.

DISTRIBUTION OF VACCINE IN THE CONTEXT OF FEAR

Supplementing the initial CDC interim smallpox response plan is prudent and is a wise step in preparing for response to a terrorist release of the smallpox virus. Although ring vaccination has proven effective in past outbreaks of smallpox,(fn5) this "proven strategy" is designed for the containment of naturally-occurring outbreaks rather than outbreaks resulting from the release of biological agents in a way that is intentionally designed to maximize their spread, such as simultaneous releases in several large airports.

The initial CDC plan presented six reasons why the ring approach is preferred over "indiscriminate mass vaccination:" 1) ring vaccination without indiscriminate mass vaccination was a successful approach used to eradicate naturally-occurring smallpox; 2) indiscriminate vaccination would lead to higher levels of adverse events, as it would be far more difficult to appropriately screen vaccine recipients for contraindications; 3) currently, there is an insufficient level of available vaccinia immuneglobulin to handle adverse events from vaccination; 4) a rapid depletion of vaccine stores would compromise the ability to address continued outbreaks; 5) mass inoculation efforts would put a severe strain on the public health and health care provider system; and 6) pressure to mass inoculate could lead to panic and negligence in adhering to appropriate disease surveillance and control measures.(fn6)

Although Bush administration plans seriously consider offering a mass vaccination to the general public on a voluntary basis, many of the reasons for the CDC's initial reliance on ring vaccination (as opposed to mass vaccination) are still salient. For example, a mass vaccination will require a significant public health infrastructure to deal with adverse events from vaccination. In particular, the severe strain on the health care system and likelihood of panic identified in the initial response plan remain problems even under the new mass vaccination guidelines. We have learned from the recent anthrax attacks that public demand for vaccination is likely to be high in the event of a terror-related smallpox outbreak. The anthrax attacks involved an agent far more "containable" than smallpox, and one that unlike smallpox, is not easily spread. Nonetheless, public fear was high, resulting in demand for Cipro and for flu vaccines that threatened avail-ability of these resources for those populations most in need, particularly the elderly. One can imagine, then, the demand for smallpox vaccination that might result from public panic induced by a terror-related outbreak of this highly contagious, deadly disease - a demand highly likely to overwhelm the public health infrastructure. As D.A. Henderson and colleagues describe:

During the smallpox epidemics in the 1960s and 1970s in Europe, there was considerable public alarm whenever outbreaks occurred and, often, a demand for mass vaccination throughout a very widespread area, even when the vaccination coverage of the population was high. In the United States, where few people now have protective levels of immunity, such levels of concern must be anticipated.(fn7)

The type of demand that Henderson and colleagues describe would simply and utterly overwhelm the health system.(fn8) The new CDC supplementary guidelines are a first step in addressing these problems. The CDC Smallpox Vaccination Clinic Guide ("Clinic Guide")(fn9) offers states a model system through which those seeking vaccination could systematically be moved through the vaccination process.(fn10) Under this plan, those entering a vaccination clinic would be screened for smallpox symptoms and possible exposure, evaluated and counseled on possible contraindications and questions about the vaccine, informed about potential side effects of the vaccine, and, finally, given the vaccine itself.(fn11) The guidelines describe staffing needs, activities and vaccination supply distribution plans in the event of a smallpox outbreak.(fn12) Flow charts, checklists for supply and personnel needs, and example Smallpox Investigational New Drug consent forms are included.(fn13)

In addition, the Department of Health and Human Services has, as of October 2002, announced plans to hire a clinician with expertise in mass panic situations.(fn14) This hiring reflects a recognition of the potential for widespread panic and the need for facilitation of clear communication under such circumstances. Recognition of the likely mass-panic that would result from a bioterror attack is wise, as we discussed above. It also calls, however...