Nurses may be pressured to violate the dictum "First, do no harm," if President Bush's smallpox vaccine program goes ahead as planned. All vaccines entail some risk of adverse reaction. Historically, smallpox vaccine has had the worst record of side effects. The risks were acceptable when smallpox was endemic but the last known case occurred 25 years ago.
Phase I of the Bush plan, announced in December, calls for the mandatory inoculation of 500,000 military personnel; 400,000 nurses, physicians, and other providers are to receive the vaccine on a voluntary basis. Phase II-no launch date announced-would include as many as 10 million health care workers and first responders.
Yet adverse reactions are a real threat to health care workers, their patients, and their families. Before 1980, the rates of severe reactions varied widely, from 49 to 900 per million. Life-threatening complications ranged from 14 to 52 per million; deaths, from one to two per million. (See "Smallpox Vaccination Revisited" and "The Smallpox Vaccine Debate," September 2002.)
The vaccine uses live cowpox virus (vaccinia); the inoculation site may shed the virus for three weeks, posing a danger to high-risk patients and others. Today, the widespread use of immunosuppressants and the prevalence of HIV, other immune disorders, and skin conditions such as eczema and atopic dermatitis make many people ineligible for vaccination. And many may not be aware of their immunologic status.
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Without even a single case of smallpox, there's no evidence of any benefit of vaccination. Until a year ago public health officials had agreed not to carry out mass vaccinations but to maintain reserve stocks of the vaccine and, in the extremely unlikely event of an outbreak, to rely on isolation and ring vaccination-the same strategy used to eradicate the disease. Despite widespread speculation about who might possess variola virus, the smallpox pathogen, no new evidence has emerged to justify the change in policy. Rather, we believe, the new policy is a ploy to generate support for war against Iraq, increased military spending, and curtailment of civil liberties.
The vaccine's side effects aren't the only adverse consequences of the plan. County and city health departments, including New York City's, anticipate having to divert resources from regular public health functions, such as screening for cancer and tuberculosis, to carry out the program. And some nurses worry that after inoculation their potential for shedding the virus would place their immunocompromised patients at risk for three weeks. Workdays lost to adverse reactions may create further hardship.
Another concern involves the Homeland Security Act of 2002, which shields from liability all who manufacture and dispense the vaccine, deeming them employees of the Public Health Service. Most institutions delayed implementation of the vaccination program until after January 24, the effective date of liability protection. The provision adds to concern that manufacturers might be lax in safety procedures when making large quantities quickly.
In light of these concerns, many health care workers are declining to volunteer for inoculation. Of particular note, the ANA asked the Bush administration to delay the start of the program (see News, page 19), the California Nurses Association is urging California hospitals not to participate, some institutions have publicly declined to participate, and some individual health care workers are pledging not to receive or give the vaccine. One such pledge, initiated by us and available online at http://www.healthworkers.org, says, in part: "My responsibility is to prevent disease, treat illness, and promote health. My obligation is to help, and above all, do no harm." Until there is evidence that smallpox is a real threat, vaccinations should be halted. We commend those who are refusing to participate. They're taking a stand for safety. And they're a model for us all.