Abstract

In early December 2002, President Bush announced plans for the immediate vaccination of approximately 500,000 health care professionals against smallpox on a voluntary basis (as well as up to 500,000 military personnel on a mandatory basis). These health care professionals would act as smallpox response teams in the event of a terror attack using this agent, treating cases and administering vaccination to the general population. Within days of Bush's announcement, however, two prominent teaching hospitals refused to vaccinate their employees against smallpox, and several others were leaning toward similar refusal? In addition, several prominent medical associations expressed concerns about smallpox vaccination prior to an actual attack using this agent, including the American Medical Association, the American Academy of Family Physicians, and the American Academy of Pediatricians. An even bleaker picture emerged in an April 2003 report from the General Accounting Office to the chairman of the U.S. Senate Committee on Governmental Affairs concerning the problems implementing the smallpox vaccination program. The report observed that hundreds of hospitals and thousands of health professionals have refused to participate in pre-event vaccination until liability and compensation issues have been resolved. (2) Compensation is viewed as because many will miss work or experience medical problems as the result of vaccination. Recent studies on the safety and efficacy of diluted doses of the smallpox vaccine, conducted primarily on young, healthy college student volunteers, resulted in a third of them missing work or school as a result of reactions to the vaccine) The result was confirmed by a CDC estimate cited in the GAO report. (4) Concern about the reaction is exacerbated by the fact that many hospitals will need to keep vaccinated employees away from vulnerable patients. The smallpox vaccine is a live vaccine that infects the recipient with a related virus. After being vaccinated, the recipient can spread this infection to others (called contact vaccinia). (5) This is especially problematic in contemporary health care settings, where there are a large number of immuno-compromised individuals--people who are HIV positive or are transplant recipients, for example. Some hospitals are considering furloughing vaccinated employees for up to three weeks to prevent the vaccinia virus from spreading to patients. (6) In late April 2003, Congress finally passed the Smallpox Emergency Personnel Protection Act of 2003, which would reimburse those participating in smallpox response activities for injuries arising as a direct result of administration of the smallpox vaccine. (7) The act will provide compensation for the reasonable and necessary costs of medical care associated with a vaccine-related injury and will pay up to $262,000 to the families of those who die as a result of the vaccine. Those suffering permanent disability can receive up to $50,000 a year annually through the compensation fund, and those who are temporarily or partially disabled can receive up to $262,000 in compensation for their injuries. However, the act leaves several significant questions about vaccination compensation unanswered: for example, which injuries will be eligible for reimbursement? (8) While agreement on the compensation issue is a step forward in implementing the administration's smallpox vaccination program, it is but one of a number of concerns inhibiting health worker participation in the vaccination program. Together, these concerns reflect a broad apprehension about the risks associated with the smallpox vaccine. (9) Known risks include encephalitis (1 in 200,000 to 300,000), death (estimates range up to 3-5 per million), and other side effects that are serious enough to require a doctor's care (in sum, 1 of every 10,000 cases). (10) Recently, three people have died of heart attacks after being vaccinated, several others have experienced heart problems, leading the CDC to issue new guidelines excluding those with heart conditions from the vaccination program. …

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