The United States Civilian Smallpox Vaccination Program
The United States Civilian Smallpox Vaccination Program
The worldwide eradication of smallpox is without question one of the greatest achievements in the fields of medicine and public health. This feat would have most certainly been impossible without global cooperation, the use of an effective vaccine, and a careful epidemiologic surveillance program. The world has not seen a case of smallpox since 1977, and the last case in the United States occurred in 1949. Smallpox was produced as a weapon by several nations well past the 1972 Bioweapons convention that prohibited such actions. The potential for intentional release of a now-eradicated, deadly communicable disease in a basically nonimmune population is truly frightening. This horrific possibility is difficult for some to imagine. However, the atrocities of September 11, 2001, and the suicide bombings in the Middle East should leave no doubt as to the ill intentions and disregard for civilian casualties exhibited by terrorist groups and rogue nations.
In response to this potential public health catastrophe, U.S. public health, as well as Department of Defense, authorities have directed the reintroduction of a smallpox vaccination program. The general civilian population has not received smallpox vaccinations since 1972; however, the Department of Defense continued to inoculate nonimmunized recruits until 1990. So, the reintroduction of a highly successful, time-proven immunization program should be a simple, uncomplicated decision, right?
The smallpox vaccination is a live-virus immunization containing vaccinia (not variola) virus. Vaccinated individuals may shed live virus for 2-3 weeks, and this shedding inadvertently can be passed to close contacts. Inadvertent exposure to this live virus can be very serious for persons with compromised immune systems or chronic diseases, and in pregnant women. This was much less of an issue during the earlier era of vaccination. We did not have advanced medical treatments that extended the lives of patients with cancer, human immunodeficiency virus infection, or autoimmune disorders, nor did we accomplish significant, successful organ or bone marrow transplantation. Also, women were generally immunized as children -- well before childbearing age.
Screening potential vaccinees and their household and work contacts for the diseases and health conditions mentioned above is now exceptionally important for a safe immunization program. In addition, potential vaccinees must be screened for skin conditions such as eczema. As a result of this screening process, many individuals may be excluded from a "pre-event" vaccination program.
The idea behind this pre-event vaccination program within the civilian community is to produce a cadre of medical and emergency personnel who would be able to investigate index cases of smallpox and care for smallpox victims while not becoming casualties themselves. This is a noble thought, but will this approach work? We must ask ourselves some tough questions, and we may not like the answers. First, can we mandate civilians to receive a vaccination or threaten to terminate their jobs if they choose not to receive it? What if a health care professional is in a "one-deep" slot with no replacement -- could an institution afford to lose this professional as a result of screening or due to refusal of the immunization?
Second, would this program protect the unvaccinated employees and patients in our facilities who might be present on that fateful day? Could we, with any accuracy, predict where and when a smallpox case might present so we could ensure that the select cadre of vaccinated employees were on duty that day? Unfortunately, the answer to this question appears to be disappointing. We absolutely cannot predict where a case may present, and those presenting with symptoms of fever and rash (and certainly prodromal fever without rash) probably would be asked to "take a seat" in the waiting room behind priority gunshot wounds, motor vehicle accidents, and myocardial infarctions. Of course this simply increases exposure risk to other staff, patients, and family. Many institutions rely on float staff and have trouble knowing exactly who will be on duty in a given area tomorrow, much less the third Tuesday of the month at 7:45 P.M. in a specific department.
Third, would having a special cadre at a facility reduce or eliminate the need for inoculations of other staff should a patient with smallpox present? No way. History shows that smallpox was transmitted quite nicely within facilities. This means that basically anyone who was anywhere near the patient, the patient's family members, or those who had contact with the patient's clothing or linens would need immediate vaccination. An inoculated special cadre, who may or may not have been on duty when the smallpox case presented, does not help the other noninoculated staff in this situation.
Fourth, once extensive screening of employees and their family members for smallpox vaccine is completed, would any facility have enough volunteers with the appropriate skill sets to provide a 24-hours/day, 7-days/week, in-house smallpox care cadre? Probably not.
Questions also arise regarding the legal and human resources issues that relate to those civilians volunteering to receive smallpox immunizations. Under section 304 of the Homeland Security Act, health departments and vaccine manufacturers are not responsible for adverse reactions experienced by individuals who receive this vaccine. This means that in the event of an adverse reaction, patients will be cared for by their private physician or employee health office. Costs for inoculation site care, any lost time from work (e.g., furloughs, if implemented) will be borne by the patient and health care institution.
Would volunteer vaccinees who miss work because of significant side effects drain their personal sick leave accounts, or would the institution provide paid time off? There appears to be no universal agreement on this question. If a household contact of a volunteer inadvertently becomes exposed to vaccine virus and becomes ill, who will care for this individual and pay for the care? So far, it appears that this financial responsibility rests with the volunteer and the family's personal health insurance. In the rare event of severe injury or death from the vaccine, will there be compensation to the volunteer and/or volunteer's family? Again, health departments and vaccine manufacturers are not responsible, and as there is no clear consensus from employers, the responsibility probably would rest with whatever health insurance the volunteer carried.
Finally, would volunteers be furloughed from work during the period of viral shedding, and would this be paid or unpaid leave? What about military reservists who receive the immunization through the military's program and then report to work at their full-time civilian jobs? Many hospitals employ a sizable number of these reservists, often in critical care areas. Currently, the Centers for Disease Control and Prevention simply recommends to cover the inoculation site with a dressing and continue business as usual. This recommendation is being intensely debated in the health care community and makes many hospital attorneys and risk managers quite nervous. Health care facilities are liable for any adverse events that happen to any patient in-house. Institutions are concerned with what the financial liability would be for an inadvertent transmission of vaccinia from a volunteer cadre member to a patient. It appears that a patient inadvertently infected with vaccinia virus from an immunized health care worker may be able to file suit. As health care professionals, we all like to think that we do a great job of handwashing and adhering to infection-control measures, which are key to preventing inadvertent transmission of vaccinia. However, statistics tracking nosocomial spread of methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci, and resistant gram-negative organisms by health care workers and equipment often tell a different story.
So what is the bottom line? The real threat of bioterrorism has increased (or will shortly) the availability and accessibility of traditional and new smallpox vaccines as well as vaccinia immune globulin. Awareness of diagnostic criteria and infection-control protocols for smallpox also has skyrocketed. These advances are great news for the medical community and population in general and are long overdue. However, a limited volunteer vaccination plan for selected medical personnel may fall short of providing the degree of preparedness and protection cited in the lay press. In order to launch a successful smallpox response plan, individual institutions must, at a minimum, ask themselves the tough legal and human resources questions I pose in this editorial and formulate solid answers before they begin program implementation with their employees.
The worldwide eradication of smallpox is without question one of the greatest achievements in the fields of medicine and public health. This feat would have most certainly been impossible without global cooperation, the use of an effective vaccine, and a careful epidemiologic surveillance program. The world has not seen a case of smallpox since 1977, and the last case in the United States occurred in 1949. Smallpox was produced as a weapon by several nations well past the 1972 Bioweapons convention that prohibited such actions. The potential for intentional release of a now-eradicated, deadly communicable disease in a basically nonimmune population is truly frightening. This horrific possibility is difficult for some to imagine. However, the atrocities of September 11, 2001, and the suicide bombings in the Middle East should leave no doubt as to the ill intentions and disregard for civilian casualties exhibited by terrorist groups and rogue nations.
In response to this potential public health catastrophe, U.S. public health, as well as Department of Defense, authorities have directed the reintroduction of a smallpox vaccination program. The general civilian population has not received smallpox vaccinations since 1972; however, the Department of Defense continued to inoculate nonimmunized recruits until 1990. So, the reintroduction of a highly successful, time-proven immunization program should be a simple, uncomplicated decision, right?
The smallpox vaccination is a live-virus immunization containing vaccinia (not variola) virus. Vaccinated individuals may shed live virus for 2-3 weeks, and this shedding inadvertently can be passed to close contacts. Inadvertent exposure to this live virus can be very serious for persons with compromised immune systems or chronic diseases, and in pregnant women. This was much less of an issue during the earlier era of vaccination. We did not have advanced medical treatments that extended the lives of patients with cancer, human immunodeficiency virus infection, or autoimmune disorders, nor did we accomplish significant, successful organ or bone marrow transplantation. Also, women were generally immunized as children -- well before childbearing age.
Screening potential vaccinees and their household and work contacts for the diseases and health conditions mentioned above is now exceptionally important for a safe immunization program. In addition, potential vaccinees must be screened for skin conditions such as eczema. As a result of this screening process, many individuals may be excluded from a "pre-event" vaccination program.
The idea behind this pre-event vaccination program within the civilian community is to produce a cadre of medical and emergency personnel who would be able to investigate index cases of smallpox and care for smallpox victims while not becoming casualties themselves. This is a noble thought, but will this approach work? We must ask ourselves some tough questions, and we may not like the answers. First, can we mandate civilians to receive a vaccination or threaten to terminate their jobs if they choose not to receive it? What if a health care professional is in a "one-deep" slot with no replacement -- could an institution afford to lose this professional as a result of screening or due to refusal of the immunization?
Second, would this program protect the unvaccinated employees and patients in our facilities who might be present on that fateful day? Could we, with any accuracy, predict where and when a smallpox case might present so we could ensure that the select cadre of vaccinated employees were on duty that day? Unfortunately, the answer to this question appears to be disappointing. We absolutely cannot predict where a case may present, and those presenting with symptoms of fever and rash (and certainly prodromal fever without rash) probably would be asked to "take a seat" in the waiting room behind priority gunshot wounds, motor vehicle accidents, and myocardial infarctions. Of course this simply increases exposure risk to other staff, patients, and family. Many institutions rely on float staff and have trouble knowing exactly who will be on duty in a given area tomorrow, much less the third Tuesday of the month at 7:45 P.M. in a specific department.
Third, would having a special cadre at a facility reduce or eliminate the need for inoculations of other staff should a patient with smallpox present? No way. History shows that smallpox was transmitted quite nicely within facilities. This means that basically anyone who was anywhere near the patient, the patient's family members, or those who had contact with the patient's clothing or linens would need immediate vaccination. An inoculated special cadre, who may or may not have been on duty when the smallpox case presented, does not help the other noninoculated staff in this situation.
Fourth, once extensive screening of employees and their family members for smallpox vaccine is completed, would any facility have enough volunteers with the appropriate skill sets to provide a 24-hours/day, 7-days/week, in-house smallpox care cadre? Probably not.
Questions also arise regarding the legal and human resources issues that relate to those civilians volunteering to receive smallpox immunizations. Under section 304 of the Homeland Security Act, health departments and vaccine manufacturers are not responsible for adverse reactions experienced by individuals who receive this vaccine. This means that in the event of an adverse reaction, patients will be cared for by their private physician or employee health office. Costs for inoculation site care, any lost time from work (e.g., furloughs, if implemented) will be borne by the patient and health care institution.
Would volunteer vaccinees who miss work because of significant side effects drain their personal sick leave accounts, or would the institution provide paid time off? There appears to be no universal agreement on this question. If a household contact of a volunteer inadvertently becomes exposed to vaccine virus and becomes ill, who will care for this individual and pay for the care? So far, it appears that this financial responsibility rests with the volunteer and the family's personal health insurance. In the rare event of severe injury or death from the vaccine, will there be compensation to the volunteer and/or volunteer's family? Again, health departments and vaccine manufacturers are not responsible, and as there is no clear consensus from employers, the responsibility probably would rest with whatever health insurance the volunteer carried.
Finally, would volunteers be furloughed from work during the period of viral shedding, and would this be paid or unpaid leave? What about military reservists who receive the immunization through the military's program and then report to work at their full-time civilian jobs? Many hospitals employ a sizable number of these reservists, often in critical care areas. Currently, the Centers for Disease Control and Prevention simply recommends to cover the inoculation site with a dressing and continue business as usual. This recommendation is being intensely debated in the health care community and makes many hospital attorneys and risk managers quite nervous. Health care facilities are liable for any adverse events that happen to any patient in-house. Institutions are concerned with what the financial liability would be for an inadvertent transmission of vaccinia from a volunteer cadre member to a patient. It appears that a patient inadvertently infected with vaccinia virus from an immunized health care worker may be able to file suit. As health care professionals, we all like to think that we do a great job of handwashing and adhering to infection-control measures, which are key to preventing inadvertent transmission of vaccinia. However, statistics tracking nosocomial spread of methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci, and resistant gram-negative organisms by health care workers and equipment often tell a different story.
So what is the bottom line? The real threat of bioterrorism has increased (or will shortly) the availability and accessibility of traditional and new smallpox vaccines as well as vaccinia immune globulin. Awareness of diagnostic criteria and infection-control protocols for smallpox also has skyrocketed. These advances are great news for the medical community and population in general and are long overdue. However, a limited volunteer vaccination plan for selected medical personnel may fall short of providing the degree of preparedness and protection cited in the lay press. In order to launch a successful smallpox response plan, individual institutions must, at a minimum, ask themselves the tough legal and human resources questions I pose in this editorial and formulate solid answers before they begin program implementation with their employees.