I 
114TH CONGRESS 
1ST SESSION H. R. 1636 
To direct the Secretary of Health and Human Services to conduct or support 
a comprehensive study comparing total health outcomes, including risk 
of autism, in vaccinated populations in the United States with such 
outcomes in unvaccinated populations in the United States, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 25, 2015 
Mr. POSEY (for himself and Mrs. CAROLYN B. MALONEY of New York) intro-
duced the following bill; which was referred to the Committee on Energy 
and Commerce 
A BILL 
To direct the Secretary of Health and Human Services to 
conduct or support a comprehensive study comparing 
total health outcomes, including risk of autism, in vac-
cinated populations in the United States with such out-
comes in unvaccinated populations in the United States, 
and for other purposes. 
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 ‘‘Vaccine Safety Study 
Act’’. 
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SEC. 2. FINDINGS. 
The Congress finds as follows: 
(1) Securing the health of the Nation’s children 
is our most important concern as parents and stew-
ards of the Nation’s future. 
(2) The Nation’s vaccine program has greatly 
reduced human suffering from infectious disease by 
preventing and reducing the outbreak of vaccine-pre-
ventable diseases. 
(3) Total health outcomes are the best measure 
of the success of any public health effort, including 
security from both chronic and infectious disease. 
(4) Childhood immunizations are an important 
tool in protecting children from infectious disease. 
(5) The number of immunizations administered 
to infants, pregnant women, children, teenagers, and 
adults has grown dramatically over recent years. 
(6) The incidence of chronic, unexplained dis-
eases such as autism, learning disabilities, and other 
neurological disorders appears to have increased dra-
matically in recent years. 
(7) Individual vaccines are tested for safety, but 
little safety testing has been conducted for inter-
action effects of multiple vaccines. 
(8) The strategy of aggressive, early childhood 
immunization against a large number of infectious 
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diseases has never been tested in its entirety against 
alternative strategies, either for safety or for total 
health outcomes. 
(9) Childhood immunizations are the only 
health interventions that are required by States of 
all citizens in order to participate in civic society. 
(10) Public confidence in the management of 
public health can only be maintained if these State 
government-mandated, mass vaccination programs— 
(A) are tested rigorously and in their en-
tirety against all reasonable safety concerns; 
and 
(B) are verified in their entirety to produce 
superior health outcomes. 
(11) There are numerous United States popu-
lations in which a practice of no vaccination is fol-
lowed and which therefore provide a natural com-
parison group for comparing total health outcomes. 
(12) No comparative study of such health out-
comes has ever been conducted. 
(13) Given rising concern over the high rates of 
childhood neurodevelopmental disorders such as au-
tism and other chronic conditions, the need for such 
studies is becoming urgent. 
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SEC. 3. STUDY ON HEALTH OUTCOMES IN VACCINATED 
AND 
UNVACCINATED 
AMERICAN 
POPU-
LATIONS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (in this Act referred to as the ‘‘Sec-
retary’’), acting through the Director of the National In-
stitutes of Health, shall conduct or support a comprehen-
sive study— 
(1) to compare total health outcomes, including 
the incidence and risk of autism, in vaccinated popu-
lations in the United States with such outcomes in 
unvaccinated populations in the United States; and 
(2) to determine whether exposure to vaccines 
or vaccine components is associated with autism 
spectrum disorders, chronic conditions, or other neu-
rological conditions. 
(b) RULE OF CONSTRUCTION.—Nothing in this Act 
shall be construed to authorize the conduct or support of 
any study in which an individual or population is encour-
aged or incentivized to remain unvaccinated. 
(c) QUALIFICATIONS.—With respect to each investi-
gator carrying out the study under this section, the Sec-
retary shall ensure that the investigator— 
(1) is objective; 
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(2) is qualified to carry out such study, as evi-
denced by training experiences and demonstrated 
skill; 
(3) is not currently employed by any Federal, 
State, or local public health agency; 
(4) is not currently a member of a board, com-
mittee, or other entity responsible for formulating 
immunization policy on behalf of any Federal, State, 
or local public health agency or any component 
thereof; 
(5) has no history of a strong position on the 
thimerosal or vaccine safety controversy; and 
(6) is not currently an employee of, or other-
wise directly or indirectly receiving funds from, a 
pharmaceutical company or the Centers for Disease 
Control. 
(d) TARGET POPULATIONS.—The Secretary shall 
seek to include in the study under this section populations 
in the United States that have traditionally remained 
unvaccinated for religious or other reasons, which popu-
lations may include Old Order Amish, members of clinical 
practices (such as the Homefirst practice in Chicago) who 
choose alternative medical practices, practitioners of 
anthroposophic lifestyles, and others who have chosen not 
to be vaccinated. 
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(e) TIMING.—Not later than 120 days after the date 
of the enactment of this Act, the Secretary shall issue a 
request for proposals to conduct the study required by this 
section. Not later than 120 days after receipt of any such 
proposal, the Secretary shall approve or disapprove the 
proposal. If the Secretary disapproves the proposal, the 
Secretary shall provide the applicant involved with a writ-
ten explanation of the reasons for the disapproval. 
(f) TRANSPARENCY.—To facilitate further research 
by the Secretary or others, the Secretary shall ensure the 
preservation of all data, including all data sets, collected 
or used for purposes of the study under this section. 
Æ 
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