A provision of the recently enacted Homeland Security Act of 2002, 42 U.S.C. §233, was written to address liability concerns of health care entities that would administer the federal smallpox vaccination. Military personnel and healthcare workers will be among the first to be vaccinated. Among other things, the new provision addresses providers' liability incurred in administering the vaccine, as well as responsibility for medical costs if providers' employees become ill when administering the vaccine. Because the effective date of the Act is January 24, 2003, this liability protection will not be in place prior to such date. Additionally, the presence in transfused blood or plasma of the virus used in smallpox vaccines could be harmful to some recipients. Even though the presence of the virus in the blood has rarely been documented, there is a risk of transmission of the virus by blood and blood products. Accordingly, the FDA has recently released guidance, wwwfda.gov/cber/gdlns/smpoxdefquar.pdf, on measures to reduce any possible risk of transmission of the virus from donors of blood and blood products.
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