The federal government is proposing immunizing 500,000 health care workers for smallpox, starting spring 2003. The objective is to prepare health care facilities and emergency services to receive patients from bioterrorism attacks with smallpox. This note discusses the potential medical risks and the attendant legal problems posed by this policy. This was previously directed to hospital attorneys because hospitals will bear the brunt of the legal risks. The intent of the authors is not to stop smallpox vaccinations, but to see them done in a way that will not injure patients and hospitals. A program with unacceptable injuries, such as happened with the Swine Flu immunization program in the 1970s, will severely damage the creditability of all vaccine programs and of public health in general.
Smallpox vaccine uses a live virus called vaccinia. It is the same family as smallpox and induces immunity to smallpox. A drop of solution containing vaccinia is put between the prongs of a very small two pronged needle, which is then punched into the patient's arm 15 times. This infects the person with vaccinia. For most persons the infection is limited to a small sore at the vaccination site. As many as 1/3 of vaccinated persons suffer fever and malaise sufficient to interfere with work or recreation, but most of these persons recover quickly without permanent sequella. The sore lasts about 2 - 3 weeks and it leaks live virus from the surface. If the person scratches the sore and then puts his/her finger and they scratches the eye or nose or somewhere else, the virus will form sores at the scratched location. The virus can also be spread to others who come into contact with the sore or its dressing. It is assumed that that people without severe illness do not spread the vaccinia virus by coughing, but it is not clear that this has been carefully studied since it did not matter when everyone was immunized. (For more techincal information on the vaccination process, see the Dryvax label.)
Smallpox vaccinations have many complications. One of the most common serious sequella is spreading of the vaccination sore and development of sores on other parts of the body. This can happen in people with eczema and other dermatological conditions. While not usually life-threatening, this is a painful, difficult to treat complication that can leave the patients permanently scared. Others suffer neurologic sequella, which can be permanent or even fatal in a small percentage of cases. When the virus spreads from the original vaccination sore, the risk of infecting others with vaccinia through secondary spread is dramatically increased. Such persons must be managed so that they are never in contact with unvaccinated persons or persons who are susceptible to vaccinia injury. If they are treated in health care facilities or hospitals they must be put in proper isolation and be managed much as a smallpox case is managed.
The most serious complication is disseminated vaccinia. (There is some confusion about the nomenclature - disseminated vaccinia in this review means the generalized spread of vaccinia throughout the body.) Disseminated vaccinia means that the immunized person's immune system could not keep the vaccinia virus confined to the vaccination sore and allowed to spread as a whole body illness, creating sores that look very much like smallpox over the patient's body. Disseminated vaccinia is often fatal. It was very rare in the 1960s and early 1970s when the last smallpox vaccinations were done in the US. It accounted for about 1 death per 1,000,000 immunizations. Studies at the time found that such cases could usually be traced to persons with defective immune systems. More importantly, the leading study determined that persons with defective cellular immunity were usually killed by the vaccine. [Freed, E. R., R. J. Duma, et al. (1972). “Vaccinia necrosum and its relationship to impaired immunologic responsiveness.” Am J Med 52(3): 411-20.]
In 1972, there were very few persons with such immune system defects. Most were children with genetic diseases, with the most severely affected dying shortly after birth because they could not fight off infection. (The bubble baby had this condition.) The others tended to be persons with undiagnosed cancers who were inadvertently vaccinated. Since 1972, the use of powerful cancer drugs, arthritis drugs, and transplant drugs, plus the emergence of HIV/AIDS, has increased the number of immunosuppressed persons by at least 100, and perhaps 1000 times as many as those in 1972.
We have little direct information on the consequences of vaccinating persons with pharmacologically suppressed immune systems or those suffering from HIV. There is one case reported in the literature where a person with HIV was immunized with smallpox vaccine. [Redfield, R. R., D. C. Wright, et al. (1987). “Disseminated vaccinia in a military recruit with human immunodeficiency virus (HIV) disease.” N Engl J Med 316(11): 673-6.] The victim was a healthy 19 year old soldier who been tested and found to have normal blood work before immunization. This was just before the HIV screening test was used for all military personal - one of the results of this case. Within 3 weeks of being vaccinated, the soldier became very ill with disseminated vaccinia. Despite intensive treatment, including many injections with human vaccine globulin (VIG), he died after a prolonged illness. It appeared that the vaccinia virus destroyed the reserve capacity of the patient's immune system, leading to a rapidly progressive case of AIDS. His vaccinia did appear to resolve before his death. Given the lack of knowledge about AIDS and HIV at the time this happened, and the unavailability of modern anti-HIV drugs, it is unknown whether he would have had the same course with modern aggressive treatment.
Taken together, these two studies, plus the other work in the literature, must be read as finding that immunizing or exposing a person with a cellular immunity defect such as HIV to smallpox vaccine has a high probability of serious illness and death. It has been informally reported that many military personel with HIV were vaccinated without these side-effects. If true, this data should be make publically available to help health care workers and others make an informed decision about accepting vaccination.
(This discussion does not deal with immunity potentially provided by the Homeland Security Act, if the Secretary issues a formal Declaration that smallpox immunizations are necessary for national security, thus triggering the immunity provisions of the Act. The Secretary has not issued such a directive at this time, so these immunity provisions are not in force. For more information, see: Legal Issues related to Smallpox Immunizations under the Homeland Security Act as passed by the House - 17 Nov 2002)
The first level of risk is the primary immunization of the hospital personnel. It is anticipated that state worker's compensation law will cover all vaccine related injuries due to primary vaccination. These claims could be significant if a person with contraindications to vaccination is inadvertently immunized. A this point in time, there are no plans to use medical testing to screen employees for immunosuppressive disease or other contraindications before vaccinating them. They will be given a questionnaire about conditions such as HIV and cancer, etc., and the decision to vaccinate will be based on this self-reporting. If hospital personnel vaccinate any non-employees, the hospital will be open to the full spectrum of medical malpractice tort liability. The most difficult claims to defend will be failure of informed consent claims. At this time, smallpox vaccine is classified as an investigational new drug, i.e., as an experimental drug. As such it is subject to much more onerous consent requirements than are FDA approved drugs. In the clinical trials being conducted with the vaccine, all persons are tested for HIV, their medical histories are screened, and their family members's medical conditions are evaluated. Doing any less for routine immunizations is arguably malpractice as long as the drug is classified as investigational. Not following the extensive consent process of the trials could support claims of failure of informed consent.
Many persons do not know that they are immunosuppressed. For example, the CDC has estimated at various times that 25-50% of persons infected with HIV do not know they are infected. Given the potential risks from inappropriate immunization, every person should tested for immune system function before vaccination. This will be difficult for hospitals to require because of various state privacy laws and anti-HIV screening laws. However, if the CDC makes it a requirement for receiving vaccine that individuals be tested for immune system defects, federal law will preempt these state controls. (There is a discussion in the Freed article about the use of killed smallpox vaccine to screen for ability to mount an immune reaction before immunizing the person with live vaccine, but little other discussion of this method.) As long as the information from the screening is handled appropriately, this will not run afoul of HIPAA or the ADA.
The second level risk is the spread from an immunized person to an unimmunized person. These can be family members or fellow workers and every person who is immunized should be counseled and educated about the possible risks to family members. If there is any question of risk, a public health investigator should review the situation and perhaps visit the family members or significant offers.
The largest group at risk are patients in the hospital. Ideally, all immunized persons should be excluded from the workplace for 2-3 weeks post immunization to assure that there is no spread to patients or co-workers. This is financially impossible for most hospitals, unless the immunization plan is spread over many years. If immunized persons stay in the workplace, they will pose a risk to immunosuppressed patients and immunosuppressed co-workers. Co-workers are covered by Workers Compensation Insurance, but there are no limits on liability for injuries to third parties. Arguably, even state caps on medical malpractice claims would not apply since this is not a medical but an administrative risk. Preventing this spread will demand immunizing workers in small groups so that newly immunized persons can be assigned to work that will keep them away from immunosuppressed patients. This will also mean keeping them from answering emergency calls or other situations where they cannot control the patients that they treat. The larger the population of immunosuppressed patients, the greater the risk.
The third level risk is spread from a secondary case to other third parties. A person with wide-spread vaccinia lesions secondary to eczema or disseminated vaccinia sheds large amounts of virus and is a significant risk to unimmunized persons, especially those with immunosuppression. Persons caring for vaccine complications must be immunized and must follow usual infection control guidelines. These patients must be kept away from all immunosuppressed persons, both family members and other patients in the hospital. This will be easy if they are sick enough to require hospitalization because they can then be put in a negative pressure isolation room. Many will not be very sick, but may have large and or multiple vaccine sores which will shed virus. They need to be very carefully managed, with the help of the health department, to assure that they do not come in contact with any immunosuppressed persons. It may be best to require that initial management of all vaccine complications be done at the health department rather than at the hospital, and that persons needing more intense care be sent to one designated facility which can set up appropriate isolation procedures. Depending on state informed consent law and precedent, the hospital may need to inform all patients admitted or in residence at the time of the immunization program that they may be exposed to smallpox vaccine virus.
Immunization programs pose difficult human resources issues. The military's campaign to immunize troops with anthrax vaccine, a relatively safe vaccine, resulted in many officers refusing immunization and, as reported by the GAO, some officers resigned rather than undergo immunization. (ANTHRAX VACCINE GAOs Survey of Guard and Reserve Pilots and Aircrew - Sept. 2002). It should be expected that some hospital personnel will refuse immunization and others will not be candidates for immunization. Such personnel cannot care for persons with vaccine complications and must be excluded from any situation where they can encounter a person with smallpox in an outbreak. These issues should be work out with employee representatives and unions before immunizations are offered.
As currently structured, the Federal smallpox vaccination effort will be carried out through state and local public health agencies (LPHAs). The hospital should have close working relationship with the LPHA. The LPHA should work with the hospital to train workers about the risks of smallpox immunization and the management of immunization complications. The LPHA should investigate home situations as appropriate to assure the safety of the family members and significant others of immunized persons. All screening and immunization should be be done by state or local health department employees, not hospital personnel. This will improve the worker's privacy protections and will shift any liability for negligent screening or unforeseen reactions to the state.
The current plan assumes a large outbreak with patients rushing to hospitals to be treated. The vaccinated health care workers will care for these patients in their hospitals. This plan makes no provision for the other patients in the hospital. Hospitals have a very limited number of isolation beds suitable for smallpox, and almost no hospitals have a safe way to get patients from the front door into those rooms without exposing others. If there are more than a small number of smallpox cases, the hospital will no longer be able to isolate them. At that point all the other patients and unimmuized staff must be moved out and the facility convered to a smallpox hospital, or the smallpox patients must be sent away.
The plan also fails to deal with the health care workers who cannot be immunized. These workers will have to be kept away from any possible smallpox cases, for their own safety and, more importantly, because unimmunized health care workers are a prime way to spread smallpox. If we are in a constant state of readiness for a smallpox outbreak, does this mean that these workers cannot be in any jobs where they might encounter an undiagnosed smallpox case? If there is a case indentified in the community, should all unimmunized workers be sent home? Who will cover their duties? What about health care workers outsidc of hosptials? Patients are as likely to go to private physicians as hospital based clinics. How should these facilities handle potenital smallpox cases?
It makes sense to vaccinate front line health emergency health care workers who are at the highest risk of encountering a smallpox case. Hospitals with emergency rooms and outpatient clinics are at risk in this scenario, and ambulance workers are at high risk. Yet this does not mean that the entire hospital staff needs to vaccinated. Smallpox cases should not be admitted or treated in every hospital in the community. They should be sent to a designated regional smallpox hospital. To minimize the risk of secondary spread of vaccinia, the regional smallpox hospital should not be a hospital with a significant number of immunosuppressed persons. There should be a plan for how to evacuate all patients and unimmunized staff to other facilities should smallpox be identified in the community. Ideally the regional hospital should be a hospital run by a government entity that is shielded by sovereign immunity. This will allow compensation under a tort claims act procedure. Ideally this should be a federal hospital such as a Veterans Administration hospital because the federal government has the best tort law protection and the best ability to spread the risk. More importantly, a federal facility will be able to absorb the tremendous financial risks of treating smallpox cases, including the potential closing of the facility if decontamination proves impossible. This is important even if the Homeland Security Act immunity is in place to prevent tort claims.
A go-slow approach in the designated hospitals will allow the screening of employees for all causes of immunosuppression and will allow better investigation of potential risk of spread among family and significant others. It will also allow careful isolation of recently vaccinated employees from immunosuppressed patients. This will build up a cadre of immunized persons to manage a potential outbreak in the medically and legally safest way.
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