Smallpox Vaccine Stockpile and Vaccination Policy

Publication Date: January 2003

Publisher: Library of Congress. Congressional Research Service

Author(s):

Research Area: Health

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Abstract:

On December 13, 2002, President George W. Bush announced the administration's long-awaited policy for vaccinating U.S. citizens against smallpox. That same day, the government began vaccinating an estimated 500,000 troops and other personnel who serve in high risk parts of the world. Voluntary vaccination of up to 500,000 civilian healthcare and public health workers probably would not begin until after January 24, 2003, a date set by Section 4 of the Homeland Security Act of 2002 (P.L. 107-296). The Bush Administration plan for civilian healthcare workers follows the October 17, 2002, recommendations made by an advisory panel to the Centers for Disease Control and Prevention (CDC) on several smallpox vaccination implementation issues. The panel advised immunizing two groups of civilians: (1) public health response teams who would investigate initial smallpox cases and implement control measures; and (2) healthcare teams composed of 50-100 individuals at each of the 5,100 acute care hospitals in the United States who would care for smallpox patients.

Smallpox vaccine has a higher rate of serious complications than any other vaccine in current use. When this vaccine was routinely given more than 30 years ago, about 1,000 persons per million vaccinated for the first time experienced reactions that were serious but not life threatening, such as accidental inoculation, in which the rash occurs elsewhere on the body (from the vaccination site) due to direct contact with vaccinia. Blindness may result if the rash develops near the eye. About 14 to 52 people per million vaccinated for the first time developed potentially life threatening reactions; one or two per million died as a result of vaccination. These more serious complications include: (1) encephalitis which may be fatal or leave survivors with paralysis or other central nervous system symptoms; (2) growth of the vaccination lesion without healing, which occurs in immunocompromised individuals and is often fatal; (3) passage of vaccinia to a fetus, which may lead to stillbirth; and (4) development of vaccinial lesions over sites where there is or has been eczema, which may be fatal. Because live vaccinia virus is used in the smallpox vaccine, complications may occur in individuals who don't even receive the vaccine but are only exposed to someone who has recently been vaccinated. The federal government is encouraging both academic scientists and companies to develop a safer vaccine and antiviral treatments.

In the Homeland Security Act of 2002 (P.L. 107-296), Congress addresses the smallpox vaccine liability concerns of vaccine manufacturers and health care workers by designating them to be federal employees for the purpose of administering smallpox vaccine. The federal government would assume liability for smallpox vaccine-related injuries and deaths under the Federal Tort Claims Act which does not permit jury trials or punitive damages. If an individual injured by the smallpox vaccine were to file suit against the federal government, that individual would be required to provide evidence of negligence. However, most vaccine-related injuries are not the result of negligence. It is expected that health care insurance and worker's compensation programs would pay for patient care expenses in the event of a smallpox vaccine-related injury. This report will be updated as needed.