I
106TH CONGRESS
1ST SESSION
H. R. 2548
To suspend further implementation of the Department of Defense anthrax
vaccination program until the vaccine is determined to be safe and
effective and to provide for a study by the National Institutes of Health
of that vaccine.
IN THE HOUSE OF REPRESENTATIVES
JULY 19, 1999
Mr. GILMAN (for himself, Mrs. KELLY, and Mr. FILNER) introduced the fol-
lowing bill; which was referred to the Committee on Armed Services, and
in addition to the Committee on Commerce, for a period to be subse-
quently determined by the Speaker, in each case for consideration of such
provisions as fall within the jurisdiction of the committee concerned
A BILL
To suspend further implementation of the Department of
Defense anthrax vaccination program until the vaccine
is determined to be safe and effective and to provide
for a study by the National Institutes of Health of that
vaccine.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Department of Defense
Anthrax Vaccination Moratorium Act’’.
SEC. 2. SENSE OF CONGRESS.
It is the sense of Congress that—
(1) a single force protection measure such as
the mandatory anthrax vaccine immunization pro-
gram should not be implemented by the Department
of Defense without regard for that measure’s own
effects on morale, retention, recruiting, and budget;
and
(2) an insufficiently proven vaccine should not
be advocated as a substitute for research, develop-
ment, and production of truly effective vaccines and
essential antibiotics, adequate personal protective
equipment, detection devices, and nonproliferation
measures.
SEC. 3. MORATORIUM OF VACCINATION PROGRAM.
The Secretary of Defense shall suspend implementa-
tion of the anthrax vaccination program of the Depart-
ment of Defense. After the date of the enactment of this
Act, no further vaccination may be administered under the
program to any member of the Armed Forces except in
accordance with this Act.
SEC. 4. STUDY BY NATIONAL INSTITUTES OF HEALTH.
(a) STUDY.—
(1) IN GENERAL.—The Director of the National
Institutes of Health shall require the appropriate na-
tional research institute to conduct or oversee an
independent study of the effectiveness and safety of
the vaccine used in the Department of Defense an-
thrax vaccination program.
(2) MATTERS TO BE STUDIED.—The Director
shall include in the study under paragraph (1) deter-
mination of the following with respect to that vac-
cine:
(A) Types and severity of adverse reac-
tions.
(B) Long-term health implications, includ-
ing interactions with other (existing and
planned) vaccines and medications.
(C) Efficacy of the anthrax vaccine for
protecting humans against all the strains of an-
thrax pathogens members of the Armed Forces
are likely to encounter.
(D) Correlation of animal models to safety
and effectiveness in humans.
(E) Validation of the manufacturing proc-
ess focusing on, but not limited to, discrep-
ancies identified by the Food and Drug Admin-
istration in February 1998 (especially with re-
spect to the filter used in the harvest of anthrax
vaccine, storage times, and exposure to room
temperature).
(F) Definition of vaccine components in
terms of the protective antigen and other bac-
terial products and constituents.
(G) Such other matters as are in the judg-
ment of the Director required in order for the
Director to make the determinations required
by subsection (b).
(3) LIMITATION.—The Director may not use
for purposes of the study any data arising from the
experience of inoculating members of the Armed
Forces with the vaccine studied because of the lack
of informed consent and inadequate recordkeeping
associated with such inoculations.
(b) REPORT.—Upon completion of the study, the Di-
rector of the National Institutes of Health shall submit
to the Committee on Government Reform of the House
of Representatives and the Committee on Governmental
Affairs of the Senate and to the Secretary of Defense a
report setting forth the results of the study. The report
shall include the Director’s determination, based upon the
results of the study, as to each of the following:
(1) Whether or not the vaccine used in the De-
partment of Defense anthrax vaccination program
has an unacceptably high systemic reaction rate.
(2) Whether or not the vaccine is effective with
respect to noncutaneous transfer of anthrax.
(3) Whether or not the vaccine will be produced
in a manner acceptable to the Food and Drug Ad-
ministration.
SEC. 5. GENERAL ACCOUNTING OFFICE STUDY.
(a) IN GENERAL.—The Comptroller General shall
conduct a study of the inoculation program referred to in
section 3 and of the effect of the use of contractor-oper-
ated facilities for that program. As part of the study, the
Comptroller General shall study the following with respect
to the inoculation program:
(1) Effects on military morale, retention, and
recruiting.
(2) Civilian costs and burdens associated with
lack of military medical care and loss of civilian sick
leave and work capacity for members of the reserve
components who experience adverse reactions while
not in military status.
(3) A system of accurately recording medical
conditions of members of the Armed Forces and
other patients before and after inoculation, including
off-duty reactions and treatment of reserve compo-
nent members and including screening for allergens