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Declaration
Regarding Administration Of Smallpox Countermeasures
I. POLICY DETERMINATIONS:
1) The attacks of September and October 2001 have heightened concern that
terrorists may have access to the smallpox virus and attempt to use it
against the American public and U.S. Government facilities abroad.
2) In light of these concerns, and in order to advance the public health
and national security, the President announced the smallpox vaccination
program on December 13, 2002.
3) Given the potential for a bioterrorist incident, administration of
smallpox countermeasures is advisable within the terms of this
declaration.
4) Smallpox vaccine is currently recommended domestically only for
smallpox response teams, health care workers, and emergency response
workers.
5) The U.S. Government is making smallpox countermeasures available to
personnel associated with certain U.S. facilities abroad and
administration of these countermeasures to such personnel is advisable
within the terms of this declaration.
6) Liability protections for manufacturers and distributors of smallpox
countermeasures and the hospitals, health care facilities, and health care
workers who will receive them and treat potentially infected smallpox
cases are integral to ensuring maximum participation in the vaccination
program.
7) Section 304 of the Homeland Security Act (P.L. 107-296) is intended to
alleviate liability concerns and therefore ensure that vaccine is
available if necessary to protect the public health.
8) Administration of a countermeasure such as smallpox vaccine is
necessarily more involved than the act of placing a drop of vaccine on a
two-pronged needle and inoculating a person’s arm. Determining who is
contraindicated; monitoring, management, and care of the countermeasure
site; evaluation of countermeasure “takes;” and contact transmission of
vaccinia, among other things, all arise out of and are directly related to
and part of the administration of the countermeasure. All such acts also
potentially give rise to legal liability that, without sufficient
protections, may significantly discourage participation in the smallpox
vaccination program.
9) Under current domestic planning, many health care entities will
designate individuals to receive countermeasures at a hospital or
vaccination clinic determined by the state. To achieve a successful
vaccination program and because it is impractical to have countermeasures
administered at every health care entity involved in the program, it is
critical that health care entities participate in this manner and that
their personnel be protected while acting within their scope of
employment.
10) It is important to the successful implementation of the vaccination
program that those workers employed by health care entities under whose
auspices a countermeasure is administered be protected by Section 304
while acting within the scope of their employment.
11) Health care entities use numerous staffing arrangements to carry out
daily functions. Individuals designated to receive covered countermeasures
and subsequently treat potential smallpox cases may fall into any of these
arrangements. Liability protection for these individuals, to the extent
described below, is necessary to encourage participation in the smallpox
vaccination program.
12) Based upon scientific data from animal model studies examining
Cidofivir's effectiveness in treating lethal pox virus infections that are
similar to smallpox, Cidofivir may be useful in treating smallpox in
humans.
II. DECLARATION
I, Tommy G. Thompson, Secretary of the Department of Health and Human
Services, have concluded, in accordance with authority vested in me under
section 224(p)(2)(A) of the Public Health Service Act, that a potential
bioterrorist incident makes it advisable to administer, on a voluntary
basis, covered countermeasures specified in this declaration for
prevention or treatment of smallpox or control or treatment of adverse
events related to smallpox vaccination, to categories of individuals named
in this declaration. The countermeasures set forth below shall be
considered to be administered pursuant to this declaration when used for
prevention or treatment of smallpox, or to control or treat the adverse
effects of smallpox vaccination.
This declaration may be amended as circumstances require.
III. COVERED COUNTERMEASURES: Countermeasures to be administered pursuant
to this declaration are:
1) Vaccinia (Smallpox) Vaccines, including the Dryvax vaccine;
2) Cidofivir and derivatives thereof;
3) Vaccinia Immune Globulin (VIG).
IV. INDIVIDUALS COVERED BY THIS DECLARATION: Individuals to whom it is
advisable to administer the covered countermeasures specified above are:
1) Health care workers who may be called upon to monitor or treat any
persons who are either (a) covered by this declaration or (b) are deemed
to be individuals to whom a covered countermeasure was administered by a
qualified person, whether domestically or abroad, pursuant to section
224(p)(2)(C) of the Public Health Service Act;
2) Any person who is a member of a smallpox response team or teams
identified by state[s] or local government entities or the United States
Department of Health and Human Services;
3) Public safety personnel, including, but not limited to, law enforcement
officers, firefighters, security, and emergency medical personnel who may
be called upon to assist smallpox response teams specified in paragraph
IV(2) above; and
4) Personnel associated with certain U.S. Government facilities abroad.
V. EFFECTIVE DATES: The declaration is effective January 24, 2003 until
and including January 23, 2004. The effective period may be extended or
shortened by subsequent amendment to this declaration.
VI. DEFINITIONS: For the purposes of this declaration, including any claim
brought against the United States pursuant to Section 224 of the Public
Health Service Act (“PHS”), as amended by Section 304 of the Homeland
Security Act, the following definitions will be used:
1) “Administration of a covered countermeasure” as used in Section
224(p)(1) of the PHS Act includes, but is not limited to, the physical
administration of a covered countermeasure; education and screening of
covered countermeasure recipients; monitoring, management, and care of the
covered countermeasure site; evaluation of covered countermeasure “takes;”
and contact transmission of vaccinia.
6) “Health care entity under whose auspices such countermeasure was
administered” as used in Section 224(p)(7)(B)(ii) of the PHS Act, includes
but is not limited to, hospitals, clinics, state and local health
departments, health care entities, and contractors of any of those
entities that (a) administer covered countermeasures; (b) designate
officials, agents, or employees to receive or administer covered
countermeasures; or (c) are identified by state or local government
entities or the United States Department of Health and Human Services to
participate in the vaccination program, whether that participation is in
the United States or abroad.
7) “Official, agent, or employee” as used in Section 224(p)(7)(B)(iv) of
the PHS Act and with respect to health care entities under whose auspices
covered countermeasures are administered, includes health care workers who
share any employment or other staffing relationship with the health care
entity.
Dated:
/s/Tommy G. Thompson
Tommy G. Thompson
Secretary
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