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Smallpox and Bioterrorism
Why the Plan to Protect the Nation Is Stalled  and What to Do
by William J. Bicknell, M.D., and Kenneth D. Bloem
William J. Bicknell, M.D., MPH, is a former commissioner of public health in Massachusetts and professor of internationalhealth at Boston University School of Public Health. Kenneth D. Bloem, former CEO of Stanford University Hospital and Georgetown University Medical Center, participated in the smallpox eradication program in the Congo and Bangladesh.
No. 85
The Iraq war is over, no weapons of mass destruc-tion (WMD) have yet been found, and the presi-dent’s smallpox plan, though sound, is running outof steam. Instead of being well on the way to pro-tecting the nation’s civilian population by vaccinat-ing up to 10 million health, emergency, and publicsafety workers, we are stalled at 37,971 vaccinatedcivilians while the military has successfully and safe-ly vaccinated more than 450,000 people. Moreover,whether or not WMD are found in Iraq, it is onlyone of a number of nations on the list of suspects.Of all biological weapons, smallpox has the great-est potential for doing widespread harm. Given thatthe risk of death or serious harm to anyone from anyform of terrorism is very low, we should live our dailylives normally, not in fear. However, to do that we needto be sure that our government is taking effective stepsto reduce the chances of terrorism and, when it occurs,to minimize its consequences. Even though there isenough vaccine for everyone, we are ill prepared torapidly contain smallpox after a bioterrorist release.Although Centers for Disease Control andPrevention (CDC) guidelines have recentlyimproved, they continue to overstate the risk of sideeffects of the vaccine and erroneously suggest that,after an attack, the techniques used decades ago toeradicate smallpox will work well today.Medicine and public health are very risk-averseprofessions in our risk-averse culture. We have notyet realized the complexity and difficulty of vaccinat-ing millions of Americans rapidly after an attack.Nor have we come to grips with the need to makerapid, possibly draconian, post-attack decisionsbased on limited data of uncertain quality. That typeof decisionmaking runs counter to the culture of public health.The Bush administration needs to revitalize ourpreparations for a smallpox bioterrorist event.
September 5, 2003
 
The President’s Plan
The September 11, 2001, terrorist attacks,followed by several anthrax mailings in the fallof 2001, forced many Americans to recognizetheir vulnerability to various bioterroristthreats. Smallpox, in particular, had a longhistory as a devastating disease before its erad-ication in the 1970s. Recently, it has capturedthe attention of homeland security planners,who view it as one of the most likely and dead-liest agents for bioterrorism. Federal govern-ment officials initially considered a programof modest pre-exposure vaccination to protectagainst deliberate release of the smallpox virusby bioterrorists.
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That approach was superced-ed when the White House announced a moreambitious plan on December 13, 2002.Phase I of the president’s plan called for thevoluntary vaccination of approximately 500,000health workers, 18 years old and older, by mid-January 2003.Phase II called for the voluntary vaccina-tion of up to 10,000,000 health and emer-gency workers in the following 90 days.Phase III, to begin in mid-2003, wouldmake the vaccine available to, but not recom-mended for, the general adult population.The plan also called for the immediate vac-cination of up to 500,000 members of thearmed forces.
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As of June 25, 2003, the militaryhad vaccinated more than 450,000 individuals;the civilian program had vaccinated only37,971 people by July 18. Some states had sus-pended their programs while awaiting guid-ance from the Centers for Disease Control andPrevention (CDC) on how to screen for cardiacconditions. In the District of Columbia, 105people have been vaccinated, in Chicago 70,and in Massachusetts 120.
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The civilian num-bers are not reassuring.
What Are the Specific Objectives of Pre-Exposure Vaccination?
We have not found the specific objectivesclearly articulated in any one place. From var-ious White House, Department of Health andHuman Services, and CDC announcements,we glean these probable objectives:Phase I
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accinate sufficient vaccinators so that,if there is an attack using smallpox, theentire country can be vaccinated within10 days.
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Vaccinate sufficient first responders toidentify, pick up, and transport patientswith suspected smallpox to hospitals.
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Vaccinate enough hospital workers inacute care hospitals so that, if a hospitalreceives a smallpox patient, it will be ableto use staff personnel who are immuneto smallpox to treat that patient.Phase II
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Vaccinate as many additional acute careworkers as possible to decrease the trans-mission of smallpox in hospitals and toensure that essential emergency medical,police, and fire services can continuewithout emergency workers being eitherat risk of smallpox or at risk of transmit-ting smallpox. Once Phase II is complet-ed, whether the event is small and ineptor major and multifocal, the nation willbe well prepared to rapidly respond toand stop an outbreak of smallpox.Phase III
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In mid-2003, after Phase II is completed,permit, but do not recommend, vaccina-tion of any healthy adult. This approachboth allows informed adults to maketheir own risk/benefit decision andincreases population immunity.When Phases I and II are completed, whetherthe event is small and inept or major and multi-focal, the nation will be well prepared to rapidlyrespond to and stop an outbreak of smallpox. If and as the general adult public opts for volun-tary vaccination in Phase III, post-exposure con-trol becomes even easier and faster. There will befewer people to vaccinate, and, as the number of people susceptible to smallpox will be reduced,disease transmission will be slowed.
Does the President’s Plan Make Sense?
The answer is yes. Why is the plan sensible?
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The civilianprogram hadvaccinated only37,971 people byJuly 18. Thecivilian numbersare notreassuring.
 
First, it is phased and selective. Limiting vacci-nation to healthy adults dramatically reducesthe risk of serious vaccine side effects. Second,by starting with 500,000 military personneland a similar number of civilians, we developcurrent data about the risks of vaccinationand can easily modify the plan if actual risksexceed those expected. Third, when Phase II iscomplete, there will be enough people vacci-nated to vaccinate the balance of the popula-tion on a voluntary basis within 10 days fromthe time the first case is identified. Finally, andof great importance, hospitals and emergencyservices will be able to continue to operatewhile intensive mass vaccination is takingplace. After an outbreak is recognized, the vastmajority of people are highly likely to acceptvoluntary vaccination. At that point there willprobably be no need for mandatory vaccina-tion and its attendant problems.
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The pre-attack plan is correctly limited tohealthy adults, as the risk of serious complica-tions and death from vaccination is substan-tially higher in children. However, the age forvaccination could safely be dropped to 10years, as the overwhelming majority of deathsand severe complications from vaccinationoccur in children 9 years of age or younger.
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If we are prepared to vaccinate rapidly after anattack, children can be isolated at home for afew days until they can be vaccinated. Thisapproach avoids a number of serious andsome fatal complications of vaccination inchildren that would likely occur if done pre-attack, while minimizing smallpox cases anddeaths post-attack.
Why Is the Plan Stalled?
The problems are not exclusive to any onegroup or agency. The administration, as we dis-cuss in more detail below, has never providedclear objectives or the rationale underlying theplan. Once announced, the plan was perceivedby many people as not being a high priority forthe administration. That perception washeightened when liability and compensationissues were addressed too late and little atten-tion was paid to concerns about funding hos-pitals and health departments for costs relatedto vaccination. In addition, many medical andpublic health professionals continue to makethree mutually reinforcing errors:
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Not distinguishing between the risk of vac-cination in healthy, well-screened adults andthe risk to children and high-risk adults.
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Not adequately recognizing the differencebetween naturally occurring disease anddisease introduced by bioterrorism. Forexample, no one has epidemic-controlexperience with smallpox in a nonim-mune, highly mobile population whereexposure will be malicious rather thanbenign. The relevance of lessons from theeradication experience (characterized byvery different circumstances) is limited.
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Not sufficiently appreciating that thedecision to undertake pre-exposure vac-cination is far more than a medical deci-sion about the risks of vaccination. Of equal or greater importance, it involvessocial, economic, and national securityconsiderations, as shown schematicallyin Figure 1.It is important to emphasize that assessingthe risk of attack is a national intelligence esti-mate, not a medical or public health estimate.Before addressing in greater depth the rea-sons why the plan is stalled, it is necessary toreview the nature of the threat and some factsabout the risks of vaccination.
The Threat
Smallpox (variola major) is a deadly scourgewith, at present, no known treatment. It has anoverall mortality rate in the unvaccinated of 30percent and leaves 60 percent to 80 percent of all survivors permanently disfigured. Smallpoxhas death rates in the very young and the elder-ly approaching 50 percent. An effective livevirus vaccine is available that rarely results indeath but somewhat less rarely causes severecomplications.
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The decision toundertakepre-exposurevaccination is farmore than amedical decisionabout the risks of vaccination. Itinvolves social,economic, andnational securityconsiderations.
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