I 
109TH CONGRESS 
2D SESSION 
H. R. 5887 
To improve vaccine safety research, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 25, 2006 
Mr. WELDON of Florida (for himself and Mrs. MALONEY) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To improve vaccine safety research, 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; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Vaccine Safety and Public Confidence Assurance Act of 
2006’’ . 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Findings. 
Sec. 3. Purpose. 
Sec. 4. Establishment of Agency for Vaccine Safety Evaluation. 
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SEC. 2. FINDINGS. 
The Congress finds as follows: 
(1) The Nation’s vaccine program has greatly 
reduced human suffering from infectious disease by 
preventing and reducing the outbreak of vaccine-pre-
ventable diseases. 
(2) The prestigious scientific journal Nature 
has noted that to maintain public confidence in vac-
cines ‘‘there is a strong case for a well-resourced 
independent agency that commends the trust of both 
the government and the public’’. Nature 439, 1–2. 
(3) Public confidence in governmental vaccine- 
safety monitoring agencies is critical to building and 
maintaining public confidence in vaccine safety. 
(4) Actual or perceived conflicts of interest un-
dermine the credibility of vaccine-safety assurances 
and reports issued by those with conflicts of interest. 
(5) The Federal Government has a responsi-
bility to take all steps feasible to ensure that re-
search evaluating the safety of existing and future 
vaccines is of the highest quality and free from con-
flicts of interest. 
(6) The Centers for Disease Control and Pre-
vention is responsible for promoting both high im-
munization rates and vaccine safety, duties perceived 
by some to constitute a conflict of interest. 
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(7) The actual or perceived conflict of interest 
between vaccine promotion and vaccine safety has 
been compounded by the fact that vaccine-safety 
programs and the National Immunization Program 
have needed to compete against each other for 
funds. Funding for vaccine-safety research should be 
completely independent from other vaccine-related 
budget priorities. 
(8) There are numerous vaccines presently in 
the development pipeline for disease prevention and 
treatment, and it is critical that the Nation develop 
longer term and more specific safety monitoring 
mechanisms. 
(9) It is critical that the Federal Government 
revamp vaccine-safety monitoring programs to focus 
increasingly on developing prevaccination screening 
tools to prevent injury, thereby raising public con-
fidence and reducing vaccine injuries. 
(10) The current structure for monitoring for 
vaccine safety, postlicensure, primarily focuses on 
epidemiology. There is inadequate funding directed 
toward independent research, including research di-
rected at understanding underlying biological mecha-
nisms and biological susceptibilities and designed to 
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understand why some children and adults develop 
serious adverse outcomes after vaccination. 
(11) Because most serious adverse reactions to 
vaccines are rare, epidemiology studies may be lim-
ited in their ability to establish or rule out causal as-
sociation or biological plausibility. 
(12) The vaccine-safety monitoring functions of 
the Department of Health and Human Services have 
tended to focus on monitoring for acute adverse 
events rather than chronic adverse events. There is 
little coordination and inadequate effort to inves-
tigate the biological mechanisms underlying vaccine- 
related adverse events. 
SEC. 3. PURPOSE. 
The purpose of this title is to direct that vaccine safe-
ty monitoring and research focus on active surveillance, 
researching biological mechanisms for acute and chronic 
adverse 
events 
following 
vaccination, 
developing 
prevaccination screening methods within a framework that 
is free from actual and perceived biases, and developing 
a vaccine safety research agenda. 
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SEC. 4. ESTABLISHMENT OF AGENCY FOR VACCINE SAFETY 
EVALUATION. 
Title XXI of the Public Health Service Act (42 
U.S.C. 300aa–1 et seq.) is amended by adding at the end 
the following: 
‘‘Subtitle 3—Agency for Vaccine 
Safety Evaluation 
‘‘SEC. 2141. ESTABLISHMENT. 
‘‘There is established in the Office of the Secretary 
the Agency for Vaccine Safety Evaluation, to be headed 
by the Director for Vaccine Safety Evaluation. 
‘‘SEC. 2142. AUTHORITIES. 
‘‘(a) IN GENERAL.—With respect to vaccines, the Di-
rector for Vaccine Safety Evaluation— 
‘‘(1) shall conduct or support safety research, 
including research on— 
‘‘(A) acute and chronic adverse reactions, 
including with respect to subpopulations; 
‘‘(B) components of vaccines, including ad-
ditives, adjuvants, and preservatives; 
‘‘(C) delivery mechanisms; and 
‘‘(D) the potential presence of adventitious 
agents in vaccines; and 
‘‘(2) shall conduct or support long- and short- 
term monitoring of vaccines for which a biologics li-
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