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. 
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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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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-
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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, 
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