Smallpox Vaccine Stockpile and Vaccination Policy (CRS Report for Congress)
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| Release Date |
Jan. 9, 2003 |
| Report Number |
RL31694 |
| Report Type |
Report |
| Authors |
Judith A. Johnson, Domestic Social Policy Division |
| Source Agency |
Congressional Research Service |
Summary:
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 health care 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 health care 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) health care 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.
