Minnesota’s Smallpox Vaccination Experience

The smallpox vaccine program, developed and implemented by the Minnesota Health Department (MDH) and described in the 2003 Kennedy School of Government report titled “When Prevention Can Kill”*, was rooted in the pivotal national experience of 9/11. The thinking at the time of 9/11 was that terrorists might use smallpox as a bioweapon directed at a vulnerable U.S. general population that had ceased receiving smallpox vaccinations in 1972. As the Department of Health and Human Services (DHS) ramped up its acquisition of a vaccine stockpile and the Centers for Disease Control and Prevention (CDC) churned out guidelines on what various agencies should do in the event of a smallpox terrorist attack, a debate erupted as to whether the general U.S. population should be vaccinated in anticipation of a smallpox outbreak.**

Some experts in the national health care community advocated vaccinating everyone in advance of an outbreak because they believed that “ring vaccination” control and containment (isolating the smallpox patient and vaccinating those who had had direct contact with him/her) would fail miserably in a terrorist attack unless the initial attack was very small and the infectiousness of the agent was quite mild.

The Advisory Committee on Immunization Practices (ACIP) recommended that a small number of volunteer health care and law enforcement officers in each state be vaccinated against smallpox—perhaps 15,000 to 20,000 people nationwide would do***. In fall 2001, CDC vaccinated 200 staff members against smallpox and then canceled plans to vaccinate more once they saw the severity of the reactions.

By July 2002, reports began to surface from the federal government that 500,000 public health and emergency workers needed to be vaccinated within eight weeks. (p. 5) Dr. Donald Henderson wryly noted that this would be difficult than one might imagine. Vaccinators required training. Vaccinees may be out of work for days. Vaccinations could cause harm. Who would pay for the all of this, including coverage for potential lawsuits?

Minnesota public health officials followed the debate and in August 2002 began to examine their bureaucracy to ascertain who would develop the smallpox vaccination plan for Minnesota. Anxiety levels rose as the following questions went unanswered: “Is Minnesota required to vaccinate? Does MDH have a policy regarding workmen’s compensation after vaccination? Who would meet with staff to explain vaccination options? Who would indemnify the state for associated costs?”

Someone said that Vice President Dick Cheney wanted rapid, universal vaccination. Yet HHS Secretary Thompson wanted a voluntary program that would wait at least two years for an improved vaccine. Thompson said, “If something bad happens as a result of smallpox vaccine, the public is not going to be blaming Dick Cheney, they’re going to be blaming Tommy Thompson.” (p. 7)

The CDC formally sent requests for state action plans on Friday, November 22, 2002, and required submission of full-fledged plans for vaccinations of medical and public health smallpox response teams by December 9, 2002. The CDC could not compel states to submit such plans because of its limited authority over state health departments. But CDC owned the vaccine stocks. And CDC wryly noted that it would provide vaccine only to states prepared to vaccinate as evidenced by full-fledged plans submitted by December 9, 2002.

The Minnesota public health officials were perplexed. Staff remarked, “There was a lot of dissension within our division as to whether or not we should do this…People felt that in public health we’re used to doing things that are pretty purely for the good. You’ve already established that the benefits outweigh the risks before you do it in a public health setting. We’re just not used to contemplating a public health activity in which people may die, there may be negative consequences [to our actions]” (p. 10) One official asked whether the vaccine program was “politically motivated…Several of us here felt really strongly that this was merely a political ruse to support a war effort, rather than a public health preparedness effort.” But others suspected that “there were people who were using objections to the smallpox vaccination program as a way of expressing their dissent form the decision to go to war.” (p. 11)

In creating their plan, the MDH officials decided there would be two (2) kinds of smallpox response teams: public health and medical. The public health teams comprised of public health doctors and public health nurses would be responsible for performing all vaccinations and also for tracing the contacts of smallpox patients. These same public health teams would conduct public health clinics to vaccinate the general population and hospital clinics to vaccinate medical personnel. The role of medical personnel would be restricted to “24-hour care for the patients.”

Once the public health officials had finished hammering out this plan, they decided what they really needed now was managers. But no one could decide who really was in charge of the smallpox vaccine program in the state public health bureaucracy. One public health official remarked, “What we learned is that when you put everybody in charge, nobody’s in charge…It just gets complicated.” (p. 12)

The work chart became more complex when the plan drafters decided to decentralize the vaccine program, which was “atypical for Minnesota.” But decentralization ultimately “made sense given the structure of Minnesota public health. Public health policy was formulated at the state level, but services were delivered at the local level…The smallpox program designers decided to organize smallpox clinics by region. This allowed them to tap existing resources” such as bioterrorism coordinators, some of them hired “only a week before the Bush smallpox vaccine announcement.”

The public health officials were challenged in dealing with hospitals because it “had to engage their cooperation at the same time it built relationships with them.” (p. 13) “Hospitals, most of them privately owned, were under no legal obligation to take part in the vaccine program. Traditionally, MDH dealt with hospitals only infrequently—usually over infectious disease outbreaks. It licensed hospitals, but had no fiscal authority over them. ‘We had to build a relationship with hospitals out of nothing,” said one public health official.

President Bush’s announced on Friday, December 13, 2002 that the nation would start vaccinating against smallpox as soon as possible to inoculate an estimated 500,000health care workers nationwide within 30 days. CDC realized that the deadline would need to be relaxed because Homeland Security Act, Section 304, which conferred liability protection to vaccinators, would come into legal effect January 24, 2003. This provided more time for MDH officials to ponder over whether or not to join the vaccination program. Former CDC director, Dr. Jeffrey Koplan (of CDC anthrax response fame, see also SEMP Biot 87 at: http://www.semp.us/biots/biot87.html ) said, “I’m not a security expert, but if you are going to ask people to use a vaccine with known and significant side effects, then you’ve got to make a very good case that the risk of exposure to the disease is real, tangible, quantitative and worth the risk you are going to take with your patients.” (p. 16) Senator Bill Frist, a physician, countered with “A vaccinated population, even a partially vaccinated population, is a protected population.” CDC’s current director, Dr. Julie Geberding voiced her support of the plan: “Although the possibility of an intentional release of smallpox is not quantifiable, the consequences of an outbreak would be great and we must be prepared.” (p. 16)

Some MDH staff felt “it was a patriotic thing.” Other staff said, “Public health was unable to ‘just say no’ in this situation even though the debate raged.” One official lamented: “You are responsible for the health of the citizens in Minnesota, and if you had the opportunity to plan and you did not take it, or by having people vaccinated that’s going to make you more prepared and you didn’t do it—then you’re screwed. It was truly a lose-lose situation.”

MDH could persuade only 42 of the state’s 142 hospitals to participate in the care of smallpox patients in the event of an outbreak. MDH meanwhile asked CDC for 4,500 doses of vaccine when it realized that it would not be able to attract the 10,000 volunteers envisioned in the plan. Officials who formerly bull-horned their concern about the perceived risk of the vaccine later lamented that “participation rates were driven lower by overreaction to the perceived risk.” (p. 22) When the vaccine arrived to Minnesota from the CDC on February 4, 2003, MDH officials expected to vaccinate at “undisclosed sites” 2,700 volunteers—1,700 hospital personnel and 1,000 public health workers. The state epidemiologist received his vaccination, saying “I couldn’t even feel it.” Nonetheless, each vaccination took up to an hour because the protocols for administering the smallpox vaccine were closer to those required in drug trials than to standard immunization clinics. Meanwhile, a few state public health officials complained that they “gave up too much policy authority, while locals complained of contradictory instructions from too many masters.” Public health officials also complained about the diversion of resources (people and money) from other critical public health programs such as visits by public health nurses to at-risk mothers, AIDS prevention programming, and tracking tuberculosis. In the final analysis, MDH vaccinated 1,400 people, ranking the state fourth in the nation for absolute numbers vaccinated.

Editor’s Note: In my lifetime, private medical doctors routinely provided their patients with smallpox vaccinations. In fact, I recall receiving my last smallpox vaccination in 1974 from my private physician as a precaution for working in Kenya. Public health agencies at the time performed the invaluable service to society of vaccinating the indigent and others without access for whatever reason to private health care services. Specially-designated hospitals provided the more exotic vaccinations. I recall, for instance, traveling to the San Francisco Veterans Administration Hospital in 1974 to receive my typhoid fever vaccination. The way the system is now configured, the public health apparatus in our country stockpiles all available smallpox vaccine product and controls all critical distribution channels right up to the point of administering the vaccine to individuals. There is no redundancy or resilience built into this bioterrorism preparedness and response system. Moreover, it ignores the potential contributions of the colossal medical infrastructure engine (hospitals, clinics, doctors) in this country, which is, incredibly, asked to stand by while the public health infrastructure attempts to build itself up to handle the enormous task asked of it.

Questions or comments? Email moleary@semp.us.

*Kristen Lundberg in 2003 wrote this case for Arnold M. Howitt, Director of the Executive Session on Domestic Preparedness, Kennedy School of Government. The full text is available for purchase for 5$ at: http://www.ksgcase.harvard.edu/.

**See also SEMP Smallpox Bioquickie at: http://www.semp.us/archives/Smallpox_BioQuicky_june2003.pdf.

***For more on ACIP, visit http://www.cdc.gov/nip/publications/ACIP-list.htm and

Biots 13 and 46 at: http://www.semp.us/biots/biot13.html & http://www.semp.us/biots/biot46.html).