I 
111TH CONGRESS 
1ST SESSION H. R. 2618 
To improve vaccine safety research, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 21, 2009 
Mrs. MALONEY (for herself and Mr. SMITH of New Jersey) 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 
2009’’. 
(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. 
VerDate Nov 24 2008 
00:08 May 27, 2009
Jkt 079200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6211
E:\BILLS\H2618.IH
H2618
smartinez on PROD1PC64 with BILLS
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. 
VerDate Nov 24 2008 
00:08 May 27, 2009
Jkt 079200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H2618.IH
H2618
smartinez on PROD1PC64 with BILLS
(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 
VerDate Nov 24 2008 
00:08 May 27, 2009
Jkt 079200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H2618.IH
H2618
smartinez on PROD1PC64 with BILLS
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 Act 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. 
VerDate Nov 24 2008 
00:08 May 27, 2009
Jkt 079200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H2618.IH
H2618
smartinez on PROD1PC64 with BILLS
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-
VerDate Nov 24 2008 
00:08 May 27, 2009
Jkt 079200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H2618.IH
H2618
smartinez on PROD1PC64 with BILLS
cense is in effect under section 351 of the Public 
Health Service Act; 
‘‘(3) shall develop a vaccine safety research 
agenda; 
‘‘(4) shall conduct or support research across a 
range of disciplines, including molecular genetics, 
toxicology, pharmacokinetics, cell biology, neurology, 
immunology, pharmacogenomics, virology, and epide-
miology; 
‘‘(5) shall conduct or support research to ad-
dress issues raised in claims of injury brought before 
the Secretary, the Attorney General of the United 
States, and State and Federal courts; 
‘‘(6) 
shall 
develop, 
evaluate, 
and 
test 
hypotheses, when appropriate, about potential ad-
verse reactions, including those generated by the De-
partment of Defense, the National Institutes of 
Health, the Centers for Disease Control and Preven-
tion, the Food and Drug Administration, the Health 
Resources and Services Administration, other gov-
ernmental agencies, and external researchers; 
‘‘(7) shall, on a regular basis, evaluate, report 
on, and explore means to promote the compliance of 
health care providers and vaccine manufacturers 
with Federal requirements for reporting adverse re-
VerDate Nov 24 2008 
00:08 May 27, 2009
Jkt 079200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H2618.IH
H2618
smartinez on PROD1PC64 with BILLS
actions related to licensed vaccines, including the re-
quirements of section 2125(b); 
‘‘(8) shall conduct or support research to evalu-
ate reports of injury following vaccine administration 
for the purpose of developing tests to prescreen indi-
viduals and subpopulations at greater risk of injury; 
‘‘(9) shall conduct or support research to evalu-
ate biological mechanisms of injury for the purpose 
of eliminating or reducing the risk of such injury 
through better prescreening tools or through modi-
fication of vaccines; 
‘‘(10) shall conduct long-term monitoring of 
new or altered vaccines, including by monitoring the 
effects of changes to the recommended childhood 
and adolescent immunization schedule of the Centers 
for Disease Control and Prevention; and 
‘‘(11) shall provide, in conjunction with the Na-
tional Library of Medicine, a clearinghouse for 
prelicensure and postlicensure studies of vaccines 
and make such clearinghouse publicly accessible by 
means of the Internet. 
‘‘(b) PERSONNEL.—In carrying out this subtitle, the 
Director for Vaccine Safety Evaluation— 
‘‘(1) may not employ any individual as an offi-
cer or employee in a position in level I, II, III, IV, 
VerDate Nov 24 2008 
00:08 May 27, 2009
Jkt 079200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H2618.IH
H2618
smartinez on PROD1PC64 with BILLS
or V of the Executive Schedule or level GS–15 of the 
General Schedule if the individual has been em-
ployed within the preceding 5 years— 
‘‘(A) by the Centers for Disease Control 
and Prevention or the Food and Drug Adminis-
tration to carry out any function relating to 
monitoring, or research on, adverse reactions 
related to a licensed vaccine or any function re-
lated to vaccine development; 
‘‘(B) by the National Institutes of Health 
to carry out any function relating to vaccine de-
velopment; or 
‘‘(C) by a vaccine manufacturer; and 
‘‘(2) shall ensure that all personnel assigned to 
carry out functions relating to vaccine monitoring or 
research on adverse reactions related to vaccines do 
not have any related professional, familial, or finan-
cial conflict of interest. 
‘‘(c) GRANT APPLICANTS.—In awarding any grant 
relating to research on adverse reactions to vaccines, the 
Director for Vaccine Safety Evaluation— 
‘‘(1) shall require applicants to disclose (and 
update every 6 months) all potential conflicts of in-
terest; 
VerDate Nov 24 2008 
00:08 May 27, 2009
Jkt 079200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H2618.IH
H2618
smartinez on PROD1PC64 with BILLS