OR/MS Today - April 2003



The Last Word


Vaccination Policy in the Large and
in the Small(pox)


By Edward H. Kaplan
and Lawrence M. Wein



On Dec. 13, 2002, following months of often acrimonious debate, President George W. Bush announced his decision to vaccinate 500,000 military personnel against smallpox, and also to begin vaccinating civilian first-responders as a step toward preparing for the possibility of a smallpox bioterror attack in the United States. That vaccinations were ordered against a disease eradicated from the planet more than 25 years ago speaks to the risk the president and his advisors must perceive regarding the possible use of smallpox as a weapon of bioterror.

The civilian plan was to proceed in three phases, with all vaccine recipients participating on a voluntary basis. Phase I would vaccinate roughly 500,000 doctors and nurses across the country, with the goal of providing a cadre of hospital staff who could handle initial cases should an attack arise while also vaccinating a pool of persons who could themselves vaccinate the public in case of an emergency. Originally, Phase I was to have been completed by the end of February of this year. The idea behind Phase II was to expand this initial vaccinated reserve by immunizing another 10 million first-responders, including police officers and firefighters, as well as additional medical personnel. Phase II was intended to be completed over the duration of 2003. Only with Phase III, slated for next year, would the public gain access to the smallpox vaccine.

At the time this column is being written, however, fewer than 25,000 first-responders have agreed to be vaccinated, and many observers and would-be participants agree that the vaccination program is virtually stalled. Why is this the case?

There are at least three reasons that volunteers have been reluctant to come forward. First and perhaps most notably, would-be participants are wary of the very small risks of serious medical consequences, including a one-in-a-million chance of death, that accompanies vaccination. While the vaccination plan does screen out those with contraindications such as immune deficiency or eczema who would be at an elevated risk, as formulated the plan did not provide compensation assurances in the event of a vaccine complication. Given that a police officer injured in the line of duty would be compensated for economic loss as well as medical expenses, why shouldn't those "injured" by the smallpox vaccine receive equivalent guarantees?

We agree that someone who actually experiences a vaccine complication should be compensated, but we disapprove of the scare tactics that have been employed in service of this argument. The risks of serious vaccine complications are very, very low, yet one routinely hears the argument that vaccinia, the live virus used in smallpox vaccination, is the "world's most dangerous vaccine." This is perhaps a true statement, but it is also like saying that Boeing 747s are the world's most dangerous commercial jets (or, for that matter, that Fruit Loops are the world's most dangerous cereal — terrible things can happen if you stick Fruit Loops in your eye!).

People routinely take death risks that greatly exceed the one-per-million historical death rates from smallpox vaccine without worry. For example, the annual number of deaths from road accidents in the United States is 145 per million (so the risk of death from a single vaccination is about the same as the risk of a road death over two-and-a-half days), while at a one-in-eight million death risk per enplanement, only five return flights carries about the same absolute risk as vaccinia. It is not that we feel vaccination is without risk, but over and over again we have heard this risk dramatically overstated. Such distortion, while perhaps politically useful in winning a deserved compensation plan (and indeed legislation for such a plan is currently being created), ultimately is a disservice. We worry that even with a compensation plan in place, many intended vaccine recipients will simply be too scared to volunteer. This does not bode well for the rest of us in the event of an emergency.

A second reason people give for not getting vaccinated is that they feel there is simply no need for such widespread preparation. Those arguing in this way refer to the historical eradication of smallpox where, supposedly, only the close contacts of smallpox cases were vaccinated (so-called ring vaccination). Such a focused vaccination plan, the argument goes, could succeed in snuffing a smallpox outbreak while vaccinating only a small fraction of the population, and therefore widespread preparatory vaccination is simply not needed.

Old ideas die hard. Without even getting into whether the claimed approach was actually implemented as described (simply looking at the ratios of the number of persons vaccinated to the number of smallpox cases in different countries suggests otherwise), we have argued elsewhere that there are many differences between the last endemic smallpox regions of the 1970s and the almost completely susceptible U.S. (and, for that matter, world) population today. There is also a rather important difference between small, natural outbreaks and potentially large, strategically placed bioterror attacks.

On the basis of a detailed modeling study, we believe that rapid mass vaccination in the event of a smallpox attack is the death-minimizing policy to follow, and we have been largely successful in convincing many government officials that this is the case. Indeed, the director of the Centers for Disease Control and Prevention (CDC) has stated recently on several occasions that the readiness goal is the ability to vaccinate the entire country within 10 days. Of course, to do so requires a very large pool of vaccinators — as in millions — underscoring the need to prepare now.

A third set of reasons people give is more political in nature. Many health care providers and public health practitioners believe that what was essentially a public health and medical decision — that is, a decision regarding vaccination — was hijacked by national and homeland security apparatchiks. The word bioterror is interesting, in that it has two parts — bio and terror. The initial smallpox vaccination recommendations from last summer came squarely from the "bio" side, for the Advisory Committee on Immunization Practices (ACIP) recommended vaccinating only 15,000 or so persons as sufficient preparation (following the ring vaccination ideas from 25 years ago). However, the president's plan goes so far beyond such minimal vaccination coverage to address the "terror" in bioterror that many prominent public health personalities have complained that their advice was not followed. More recently, some of this dissent has coupled with opposition to the possibility of war with Iraq, with statements suggesting that refusing to volunteer can hinder movement toward war (or conversely, that participation in the smallpox vaccination plan makes war more likely). As documented in The New York Times among other sources, refusing to be vaccinated for this reason is seen as equivalent to "Hell no! We won't go!" from years past.

While we respect the voluntary aspect of the smallpox preparedness plan, it is also important to note that, according to recent surveys of the public at large, more than half of respondents would get vaccinated now if they could. But of course, they can't as of now. The irony is that the best argument against population-wide immunization today is that a well-oiled emergency response system can almost guarantee that vaccine would reach you before smallpox could in the event of an attack — if we "build the button now" and adequately prepare.

As of this writing, federal officials are making a renewed push to jump-start the vaccination program. In addition to legislating a smallpox vaccine compensation plan, both the surgeon general and the CDC director have been vaccinated publicly with the hope that, having seen the nation's leading public health officials vaccinated, medical first-responders will play "follow the leader" in short order. Whether or not this will occur remains to be seen.



Edward H. Kaplan (edward.kaplan@yale.edu) is the William N. and Marie A. Beach Professor of Management Sciences at the Yale School of Management, and Professor of Public Health at the Yale School of Medicine.

Lawrence M. Wein (wein_lawrence@gsb.stanford.edu) is Professor of Operations, Information and Technology at the Stanford Graduate School of Business.






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