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Project Information

Project Information


Review of Adverse Effects of Vaccines


Project Scope:

The committee will review the epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the Vaccine Injury Compensation Program. The vaccines to be reviewed are varicella zoster vaccine, influenza vaccines, hepatitis B vaccine, and human papillomavirus vaccine. Other vaccines could be added if additional funding is secured. The committee will author a consensus report with conclusions on the evidence bearing on causality and the evidence regarding the biological mechanisms that underlie specific theories for how a specific vaccine is related to a specific adverse event.

The project is sponsored by the U.S. Department of Health and Human Services.

The approximate start date for the project is 25 September 2008.

A report will be issued at the end of the project.

Status: Completed

PIN: PHPH-H-08-17-A

Project Duration (months): 33 month(s)

RSO: Stratton, Kathleen

Topic(s):

Health and Medicine



Geographic Focus:

Committee Membership

Committee Post Date: 07/30/2009

Ellen W. Clayton - (Chair)
Vanderbilt University

Ellen Wright Clayton, J.D., M.D., is professor of genetics and health policy at Vanderbilt University, where she is a professor of law and of pediatrics. She is also the director of Vanderbilt’s Center for Biomedical Ethics and Society and is a general pediatrician at Vanderbilt Medical Center. Her research and teaching interests include pediatrics, medical and research ethics, legal and ethical issues in children’s and women’s health, and genetics and health policy. She has served as a member on numerous committees for the National Institutes of Health, including the Ethical, Legal, and Social Issues Working Group of the Newborn Screening Taskforce, Maternal and Child Health Bureau, Health Resources Services Administration. Dr. Clayton has served as a consultant to the Food and Drug Administration on the topic of clinical pharmacology during pregnancy. She is a member of the Institute of Medicine (IOM) and has served on several National Academies committees, as well as the IOM’s Health Sciences Policy Board. She has numerous publications in books, medical journals, interdisciplinary journals, and law journals on the intersection of law, medicine, and public health. Dr. Clayton received her M.D. from Harvard University in 1985 and her J.D. from Yale University in 1979.
Inmaculada B. Aban
University of Alabama at Birmingham

Inmaculada B. Aban, M.S., Ph.D., is associate professor in the Department of Biostatistics at the University of Alabama, Birmingham (UAB). Dr. Aban’s current research interests are statistical methods in clinical trials, survival and reliability analysis, goodness-of-fit and model diagnostics, and inference for overdispersed count data and heavy tailed distribution. She has extensive experience in teaching statistics courses and in providing statistical consulting. Her current collaborative projects involve clinical trials in the areas of myasthenia gravis and heart failure. She is also a research faculty at the UAB Center for AIDS Research. Dr. Aban received her master’s degree in applied statistics and doctorate degree in mathematics with a concentration in statistics from Bowling Green State University, and completed her undergraduate degree in statistics at the University of the Philippines. Before she joined UAB in 2004, she was a faculty member of the Department of Mathematics and Statistics at the University of Nevada, Reno.
Douglas J. Barrett
University of Florida

Douglas J. Barrett, M.D., is senior vice president for health affairs at the University of Florida. In this position, he is responsible for maximizing the performance of the educational, research, and clinical programs in the six colleges of the University of Florida’s Health Sciences Center. Dr. Barrett is a practicing pediatrician and active in the American Academy of Pediatrics, American Board of Pediatrics, Association for Academic Health Centers, and the Society for Pediatric Research. He serves on the editorial board for Contemporary Pediatrics and is a reviewer for multiple journals. He is the author or co-author of three books, several book chapters, and more than 110 journal articles. Dr. Barrett’s research in childhood immune responses, immunodeficiency disease, and transplantation has been supported by grants from the National Institutes of Health, American Heart Association, and the American Cancer Society. Dr. Barrett received his M.D. in 1974 from the University of South Florida in Tampa and completed his pediatric internship training at Tampa General Hospital and All Children’s Hospital. After finishing a pediatric residency at SUNY/Upstate Medical Center in Syracuse, New York, he pursued his fellowship training in pediatric immunology in the Department of Pediatrics at the University of California, San Francisco.
Martina Bebin
University of Alabama at Birmingham

Martina Bebin, M.D., M.P.A., is associate professor of neurology and pediatrics at the University of Alabama at Birmingham. She is a practicing child neurologist and her research interests include pediatric clinical drug development for epilepsy and outcomes research of epilepsy patients, with a focus on treatment of epilepsy in children. She has clinical responsibility for the care of children enrolled in a clinical trial supported by Novartis for treatment of tuberous sclerosis patients with subependymal giant cell tumors of the brain. She is currently working on the Tuberous Sclerosis Alliance Natural History Database Project, funded by the Tuberous Sclerosis Alliance and the Centers for Disease Control and Prevention. She is a former Robert Wood Johnson Foundation Health Policy fellow. Dr. Bebin received her M.D. from the University of Mississippi School of Medicine in 1986. She completed her pediatric and neurology training at the Mayo Clinic in Rochester, Minnesota and a fellowship in epilepsy at the University of Virginia. In 2005 she earned her M.P.A. from Harvard University-Kennedy School of Government.
Kirsten Bibbins-Domingo
San Francisco General Hospital

Kirsten Bibbins-Domingo, Ph.D., M.D., M.A.S., is associate professor of medicine and epidemiology and biostatistics at the University of California, San Francisco, and an attending physician at San Francisco General Hospital. Dr. Bibbins-Domingo is an active researcher in preventive cardiology, the epidemiology of cardiovascular disease in young adults, and race and gender health and healthcare disparities. Her research has examined the development of cardiovascular risk factors in young adults, the effectiveness of screening and diagnostic tests for cardiovascular disease, and computer-simulated projections of future cardiovascular disease trends and the impact of public health and clinical interventions on cardiovascular disease prevention. Dr. Bibbins-Domingo served on the IOM Committee on Evaluation of the Presumptive Disability Decision-Making Process for Veterans from 2006 to 2007. She received her undergraduate degree in molecular biology and public policy from Princeton University and her medical degree, Ph.D. in biochemistry, and Masters of Clinical Research from the University of California, San Francisco.
Martha Constantine-Paton
Massachusetts Institute of Technology

Martha Constantine-Paton, Ph.D., is investigator at the McGovern Institute for Brain Research and Professor in the departments of Brain and Cognitive Sciences and Biology at the Massachusetts Institute of Technology (MIT). Previously, she was professor of biology at Yale University from 1985 until 1999, and a faculty member at Princeton University from 1976 through 1984, before joining MIT in 1999. Dr. Constantine-Paton studies activity-dependent brain development, glutamate receptor regulation, and physiology of the developing visual system in animal models. She is interested in the biochemical, structural, or genetic programs that cause the developing brain to lose its plasticity or to compensate for genetic mutations or trauma as the brain matures, possibly leading to loss of learning and memory or to neurological or neuropsychiatric disease. Dr. Constantine-Paton earned her Ph.D. in 1976 from Cornell University. She has received a number of honors and awards among them the Young Investigator Award from the Society of Neuroscience and a Merit Award from the National Eye Institute. She has served on numerous committees and councils. She has previously worked for the Institute of Medicine on panels that suggested new nutritional guidelines and explored the ethics and value of fetal tissue use. She has been a member of several grant review panels at the National Institutes of Health, including the National Advisory Eye Council and the Child Council Workgroup for the National Institute of Mental Health.
Deborah J. del Junco
The University of Texas-Houston Health Science Center

Deborah J. del Junco, Ph.D., is the senior epidemiologist at the Center for Clinical and Translational Sciences at the University of Texas Health Science Center-Houston (UTHSC-H), and associate professor in the Department of Pediatrics (UTHSC-H School of Medicine) and the Division of Epidemiology and Disease Control (UTHSC-H School of Public Health). Her research and teaching have focused on epidemiology methods, gene-environment, and other complex interactions among etiologic factors in chronic disease, records linkage, meta-analysis, reproductive health, autoimmune disease, and Rett syndrome. She is an executive editor of Epidemiologic Perspectives and Innovations. She has many publications in peer-reviewed journals and has served on a large number of review panels and advisory committees for the National Institutes of Health, Centers for Disease Control and Prevention, and Department of Defense. Dr. del Junco completed a fellowship in the Department of Epidemiology and Biostatistics at the Mayo Clinic in Rochester, Minnesota in 1984 and received her Ph.D. in epidemiology from the University of Texas Houston Health Science Center in 1988.
Betty A. Diamond, M.D.
The Feinstein Institute for Medical Research North Shore-LIJ Health System

Betty A. Diamond, M.D., is head of the Center for Autoimmune and Musculoskeletal Disease at the Feinstein Institute for Medical Research. Her research has focused on the immune system and autoimmune diseases, with an interest in Systemic Lupus Erythematosus. Dr. Diamond is a practicing rheumatologist and has received many honors, including the Outstanding Investigator Award from the American College of Rheumatology, the Lee Howley Award from the Arthritis Foundation, the Recognition Award from the National Association of M.D.-Ph.D. Programs, and election to the Institute of Medicine. She is also on the Scientific Council of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Board of Directors of the American College of Rheumatology. She has a grant from Autism Speaks to study the effects of maternal autoantibodies on fetal development. Dr. Diamond earned her medical degree from Harvard Medical School in 1973, and then completed a residency in internal medicine at Columbia Presbyterian Medical Center and a post-doctoral fellowship in immunology at the Albert Einstein College of Medicine.
S. Claiborne Johnston
University of California, San Francisco

S. Claiborne Johnston, M.D., Ph.D., is associate vice chancellor of research, director of the Clinical and Translational Science Institute, professor of neurology and epidemiology, and director of the Neurovascular Disease and Stroke Center at the University of California, San Francisco. He is a practicing neurologist and his research has focused on stroke treatment and prevention. In the past, he has had funding from both Sanofi and Novartis to study drugs used in the treatment of stroke. Dr. Johnston has authored over 200 publications in scientific journals and has won several national awards for his research and teaching. He was a member of the California Health Disease and Stroke Prevention Advisory Council, which advises the Department of Health Services, and was co-director of Prevention Education Programs for the National Stroke Association. Dr. Johnston received his M.D. from Harvard Medical School and Ph.D. in epidemiology from the University of California, Berkeley School of Public Health.
Anthony L. Komaroff
Brigham and Women's Hospital

Anthony L. Komaroff, M.D., is the Steven P. Simcox, Patrick A. Clifford, and James H. Higby Professor of Medicine at Harvard Medical School, senior physician at Brigham and Women's Hospital, and editor-in-chief of Harvard Health Publications. He was director of the Division of General Medicine and Primary Care at Brigham and Women's Hospital for 15 years and is the founding editor of Journal Watch, a summary medical information newsletter for physicians published by the Massachusetts Medical Society. Dr. Komaroff practices internal medicine (primary care and consultative medicine). For 25 years, he has conducted research on chronic fatigue syndrome, including studies of the prevalence of the illness, symptom presentation and functional capacity, as well as virologic, immunologic, and neurologic studies. He is the author of over 200 journal articles and book chapters and of one book, and is a fellow of the American College of Physicians and of the American Association for the Advancement of Science. Dr. Komaroff received his M.D. from the University of Washington.
B. P. Lawrence
University of Rochester School of Medicine and Dentistry

B. Paige Lawrence, Ph.D., is associate professor of environmental medicine, and microbiology and immunology in the Molecular Toxicology and Environmental Medicine Cluster at the University of Rochester School of Medicine and Dentistry. Dr. Lawrence’s research is focused on defining the molecular mechanisms by which pollutants adversely affect the immune response to respiratory infection. This work includes the impact of acute exposure to environmental contaminants as well as the consequences of prenatal (maternal) exposures on immune function in the next generation. Her work has shown that aryl hydrocarbon receptor may have a complex mediating effect in the body and results have demonstrated impacts on immune system function, including inflammatory responses and fighting viral infections. Dr. Lawrence has numerous peer-reviewed publications and professional awards, and serves on the editorial board for several toxicology journals. She received her Ph.D. in cell biology from Cornell University in 1993, and post-doctoral training in immunology and toxicology at Oregon State University.
M. L. Markert
Duke University Medical Center

M. Louise Markert, M.D., Ph.D., is associate professor of pediatrics and immunology in the Division of Pediatric Allergy and Immunology at Duke University School of Medicine. Dr. Markert has pioneered the development of thymus transplantation for T cell reconstitution in infants born with complete DiGeorge anomaly. DiGeorge anomaly is a congenital disorder characterized by defects of the heart, parathyroid and thymus. Complete DiGeorge anomaly is fatal because of the absence of functional thymus leading to profound primary immunodeficiency. In research protocols to date, 59 infants with complete DiGeorge anomaly have been transplanted with postnatal cultured human thymic epithelial tissue. Over 70% of these infants survive and have developed functional T cells. Dr. Markert graduated from Smith College with a B.A. in biochemistry and then completed the M.D./Ph.D. program at Duke University. She received her Ph.D. in immunology, completed a two year pediatric residency at Duke, and then a three year fellowship in pediatric allergy and immunology. Dr. Markert joined the Duke faculty in 1987. She was program director of the Duke NIH-funded General Clinical Research Center from 1993 to 2004. From 1996 to 2004, she served on the American Board of Allergy and Immunology and was chair of the Board in 2002. Dr. Markert has published over 40 research articles plus invited chapters and reviews.
Marc C. Patterson
Mayo Clinic

Marc C. Patterson, M.D., is chair of the Division of Child and Adolescent Neurology and professor of neurology, pediatrics, and medical genetics at Mayo Clinic. Dr. Patterson is a child neurologist with special expertise in neurometabolic and neurogenetic disorders. His research has focused on neurometabolic disorders, with a particular focus on Niemann-Pick disease, Type C, Gaucher disease, and Congenital Disorders of Glycosylation. Dr. Patterson was born and educated in Australia, where he graduated from the University of Queensland, before training in medicine, pediatrics, and neurology at the Royal Brisbane, Royal Children’s and Royal Women’s Hospitals in Brisbane. He competed further training in pediatrics and child neurology at Mayo Graduate School of Medicine, and a fellowship in neurometabolic diseases with Roscoe Brady at the National Institutes of Health. On completion of training, Dr. Patterson joined the staff of Mayo Clinic and faculty of Mayo Medical School, where he was associate professor in the Departments of Neurology, Pediatric and Adolescent Medicine, and Medical Genetics. In 2001, he moved to New York and was professor of clinical neurology and pediatrics at Columbia University and director of pediatric neurology at The Neurologic Institute of New York and Children’s Hospital of New York – Presbyterian. In 2007, he returned to Mayo Clinic.
Hugh A. Sampson
Mount Sinai School of Medicine

Hugh A. Sampson, M.D., is professor of pediatrics and immunology at the Mount Sinai School of Medicine. He is also director of the Jaffe Food Allergy Institute, dean for Translational Biomedical Sciences at the Mount Sinai Medical Center, and a practicing pediatric allergist. Dr. Sampson’s research has focused on food allergic disorders, including work on the immuno-pathogenic role of food hypersensitivity in atopic dermatitis, the pathogenesis of food-induced anaphylaxis, characterization of food-induced gastrointestinal hypersensitivities, and immunotherapeutic strategies for treating food allergies. He holds a patent for a potential treatment vaccine for peanut allergy. Dr. Sampson is the past-president of the American Academy of Allergy, Asthma, and Immunology and a member of the Institute of Medicine. He is a co-editor of Pediatric Allergy and Immunology and has served on the editorial board of the Journal of Allergy and Clinical Immunology, and Clinical and Experimental Allergy. Dr. Sampson received his medical degree from the State University of New York, then finished a residency in pediatrics at the Children’s Memorial Hospital, and completed a fellowship in allergy and immunology at Duke University.
Pauline A. Thomas
University of Medicine and Dentistry of New Jersey

Pauline A. Thomas, M.D. is associate professor in the Department of Preventive Medicine and Community Health, with joint appointments in OB/GYN/Women’s Health and Pediatrics at New Jersey Medical School, and in the School of Public Health, Newark Campus-University of Medicine and Dentistry of New Jersey. She is also a practicing pediatrician. Her research interests include pediatric HIV, public health practice and surveillance methodology, and health care delivery. She served as assistant commissioner for surveillance in the Division of Epidemiology at the New York City Department of Health and Mental Hygiene and director of the Health Department’s Office of AIDS Surveillance. Dr. Thomas received her medical degree from Yale University School of Medicine in 1977 and completed her residency in pediatrics at Strong Memorial Hospital of the University of Rochester, New York.
Leslie P. Weiner
University of Southern California School of Medicine

Leslie P. Weiner, M.D., is professor of neurology and molecular microbiology and immunology and holds the Richard Angus Grant, Sr. Chair in Neurology at the Keck School of Medicine of the University of Southern California (USC). Dr. Weiner earned his medical degree from the University of Cincinnati and completed his neurology residency at the Johns Hopkins Hospital. At Johns Hopkins, he also pursued a fellowship in neurology and epidemiology, focusing on viruses of the nervous system. He then completed a fellowship at the National Institutes of Health Laboratory of Slow Virus Infections. Dr. Weiner served as chair of the USC Department of Neurology for 25 years and he remains a practicing neurologist. Dr. Weiner’s research interests include a human T cell vaccine for the treatment of secondary progressive multiple sclerosis (MS), gene therapy for MS, molecular mimicry, and more recently, neural stem cells. He has written more than 200 papers and has received numerous honors. He served as an expert witness for a federal judge in cases regarding adverse effects of the swine flu vaccine in the 1970’s.

Committee Membership Roster Comments

Note (5/29/2009): There has been a change in committee membership with the addition of Martha Constantine-Paton.

Note (7/30/2009): There has been a change in committee membership with the addition of Inmaculada B. Aban, Kirsten Bibbins-Domingo, M. Louise Markert, Ruby H.N. Nguyen, and Marc C. Patterson.

Note (5/18/2010): There has been a change in committee membership with the 3/18/2010 resignation of Ruby H.N. Nguyen.

Note (8/18/2010): There has been a change in committee membership with the 8/9/2010 resignation of Graham A. Colditz..

Events



Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Trevonne Walford
Contact Email:  vaccinesafety@nas.edu
Contact Phone:  -

Agenda
This meeting was closed in its entirety.

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Ellen Wright Clayton (Chair)
Inmaculada B. Aban
Douglas J. Barrett
Martina Bebin
Martha Constantine-Paton
Betty A. Diamond
Anthony Komaroff
B. Paige Lawrence
M. Louise Markert
Marc Patterson
Hugh A. Sampson
Pauline A. Thomas
Leslie P. Weiner


The following topics were discussed in the closed sessions:

March 10, 2011; 8:00 am – 12:30 pm
The committee discussed conclusions of the vaccines.

March 10, 2011; 12:30 pm – 5:00 pm
The committee discussed wording and special topics for consideration.

March 11, 2011; 8:00 am – 12:30 pm
The committee discussed wording and special topics for consideration.



The following materials (written documents) were made available to the committee in the closed sessions:

None.

Date of posting of Closed Session Summary:
March 15, 2011
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Trevonne Walford
Contact Email:  vaccinesafety@nas.edu
Contact Phone:  -

Agenda
This meeting is closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Ellen Wright Clayton (Chair)
Inmaculada B. Aban
Douglas J. Barrett
Martina Bebin
Kirsten Bibbins-Domingo (Teleconference)
Martha Constantine-Paton
Deborah J. del Junco
Betty A. Diamond (Teleconference)
Anthony L. Komaroff
B. Paige Lawrence
M. Louise Markert
Marc Patterson
Hugh A. Sampson
Pauline A. Thomas
Leslie P. Weiner


The following topics were discussed in the closed sessions:

November 17, 2010; 8:00 am – 5:00 pm
The committee discused the scientific literature for the certain adverse events and the results of the updated searches.

November 18, 2010; 8:00 pm – 2:30 pm
The committee continued to review the evidence, discussed future meeting plans, and further discussed draft language for the final report.




The following materials (written documents) were made available to the committee in the closed sessions:

None.

Date of posting of Closed Session Summary:
December 01, 2010
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Trevonne Walford
Contact Email:  vaccinesafety@nas.edu
Contact Phone:  -

Agenda
This meeting was closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Ellen Wright Clayton (Chair)
Inmaculada B. Aban
Douglas J. Barrett
Martina Bebin
Kirsten Bibbins-Domingo
Martha Constantine-Paton
Deborah J. del Junco
Betty A. Diamond
Anthony L. Komaroff
B. Paige Lawrence
M. Louise Markert
Marc Patterson
Hugh A. Sampson
Pauline A. Thomas
Leslie P. Weiner


The following topics were discussed in the closed sessions:

August 11, 2010; 8:00 am – 12:30 pm
The committee discussed conclusions of the first four vaccines.

August 11, 2010; 8:00 am – 12:30 pm
The committee discussed wording and special topics for consideration.

August 12, 2010; 8:00 am – 12:30 pm
The committee reviewed the scientific literature for the certain adverse events.

August 12, 2010; 12:30 pm – 2:30 pm
The committee discussed future meeting plans and further discussed draft outline for final report.


The following materials (written documents) were made available to the committee in the closed sessions:

None

Date of posting of Closed Session Summary:
August 16, 2010
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Trevonne Walford
Contact Email:  twalford@nas.edu
Contact Phone:  202-334-2294

Agenda
This meeting was closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Ellen Wright Clayton (Chair)
Inmaculada B. Aban
Douglas J. Barrett
Martina Bebin
Kirsten Bibbins-Domingo
Graham A. Colditz
Martha Constantine-Paton
Deborah J. del Junco
Betty A. Diamond
S. Claiborne Johnston
Anthony L. Komaroff
B. Paige Lawrence
M. Louise Markert
Marc Patterson
Hugh A. Sampson
Pauline A. Thomas
Leslie P. Weiner


The following topics were discussed in the closed sessions:

April 28, 2010; 8:00 am – 9:00 am
The committee reviewed goals and handled general committee business.

April 28, 2010; 9:00 – 5:00 pm
The committee began reviewing the scientific literature

April 29, 2010; 8:00 am – 2:30 pm
The committee continued to review the scientific literature, discussed future meeting plans, discussed draft outline for final report.


The following materials (written documents) were made available to the committee in the closed sessions:

None

Date of posting of Closed Session Summary:
April 04, 2010
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Trevonne Walford
Contact Email:  vaccinesafety@nas.edu
Contact Phone:  -

Agenda
This meeting is closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Chi Chi Aban
Doug Barrett
Martina Bebin
Kirsten Bibbins-Domingo
Ellen Clayton
Graham Colditz
Martha Constantine-Paton
Deb del Junco
Betty Diamond
Clay Johnston
Tony Komaroff
Paige Lawrence
M. Louise Markert
Marc Patterson
Hugh Sampson
Polly Thomas
Les Weiner


The following topics were discussed in the closed sessions:

March 10, 2010; 8:15 am – 9:00 am
The committee reviewed goals and progress to date.

March 10, 2010; 9:00 – 5:00 pm
The committee reviewed the scientific literature

MArch 11, 2010; 8:00 am – 3:30 pm
The committee continued to review the scientific literature, discussed future meeting plans, discussed draft outline for final report.


The following materials (written documents) were made available to the committee in the closed sessions:

None.

Date of posting of Closed Session Summary:
April 21, 2011
Publication(s) resulting from the event:

-


Location:

Arnold and Mabel Beckman Center
100 Academy Way, Irvine, CA 92617
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Trevonne Walford
Contact Email:  vaccinesafety@nas.edu
Contact Phone:  202-334-2294

Agenda
This meeting was closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Ellen Wright Clayton (Chair)
Inmaculada B. Aban
Douglas J. Barrett
Martina Bebin
Kirsten Bibbins-Domingo
Graham A. Colditz
Martha Constantine-Paton
Deborah J. del Junco
Betty A. Diamond
S. Claiborne Johnston
Anthony L. Komaroff
B. Paige Lawrence (via teleconference)
M. Louise Markert
Ruby H.N. Nguyen
Marc Patterson
Hugh A. Sampson
Pauline A. Thomas
Leslie P. Weiner


The following topics were discussed in the closed sessions:

January 6, 2010; 8:15 am – 9:00 am
The committee reviewed goals and progress to date.

January 6, 2010; 9:00 – 5:00 pm
The committee began reviewing the scientific literature

January 7, 2010; 8:00 am – 5 pm
The committee continued to review the scientific literature, discussed future meeting plans, discussed draft outline for final report.


The following materials (written documents) were made available to the committee in the closed sessions:

None

Date of posting of Closed Session Summary:
January 14, 2010
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Erin Rusch
Contact Email:  vaccinesafety@nas.edu
Contact Phone:  202-334-2077

Agenda
The meeting will be available via a toll-free, listen only phone line. Please dial 1-800-508-7891 and the room number *1979783* to enter the meeting. Please note that the * star key is required before and after the room number. For more information, please visit the project website at www.iom.edu/VaccineAdverseEffects. Speaker presentations will be available on the project website the day of the meeting and an unedited verbatim transcript will be posted approximately three weeks after the meeting.

The agenda below includes estimated times. The meeting may end early if the speakers do not use all the time alotted.

Committee to Review Adverse Effects of Vaccines
Meeting 3
Wednesday, August 26, 2009
9:45 am - 1:00 pm
Room 100
Keck Center of the National Academies
500 5th Street, NW
Washington, DC 20001

DRAFT AGENDA

9:45 - 10:00 am
Welcome and Introduction of the Committee
Ellen Wright Clayton, J.D., M.D., Committee Chair

10:00 - 10:45 am
The Immune Response to Vaccines and Natural Infection
Neal Halsey, M.D.
Professor
Departments of International Health, Disease Prevention & Control, and Pediatrics
Johns Hopkins Bloomberg School of Public Health

10:45 - 11:00 am
Discussion

11:00 - 11:45 am
Antibodies, Vaccines, Neuroinflammation, and the Blood-Brain Barrier
William Banks, M.D.
Professor
Departments of Internal Medicine, Geriatric Division and Pharmacological and Physiological Science
Saint Louis University School of Medicine

11:45 - 12:00 pm
Discussion

12:00 - 12:45 pm
Metabolic and Other Genetic Syndromes
Bruce Cohen, M.D.
Chief, Section of Pediatric Neurology
Departments of Neurosurgery and Pediatrics
Brain Tumor and NeuroOncology Center
Cleveland Clinic

12:45 - 1:00 pm
Discussion

1:00 pm
Adjourn
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Ellen Wright Clayton (Chair)
Inmaculada B. Aban
Douglas J. Barrett
Martina Bebin
Kirsten Bibbins-Domingo
Graham A. Colditz
Martha Constantine-Paton
Deborah J. del Junco
Betty A. Diamond
S. Claiborne Johnston
Anthony L. Komaroff
B. Paige Lawrence
M. Louise Markert
Ruby H.N. Nguyen
Hugh A. Sampson
Pauline A. Thomas
Leslie P. Weiner

The following topics were discussed in the closed sessions:

August 26, 2009; 8:30 am – 9:30 am
The committee conducted the conflict of interest and potential sources bias discussion for new members, per NRC procedure.

August 26, 2009; 1:30 pm – 5:00 pm
The committee assigned workgroups and began discussing the literature.

August 27, 2009; 8:30 am – 1:30 pm
The committee discussed the speaker presentations from the open session and reviewed the status of the workgroups. The committee also outlined items to discuss at the next meeting.


The following materials (written documents) were made available to the committee in the closed sessions:

None.

Date of posting of Closed Session Summary:
September 09, 2009
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Erin Rusch
Contact Email:  vaccinesafety@nas.edu
Contact Phone:  202-334-2077

Agenda
The meeting will be available via a toll-free, listen only phone line. Please dial 1-800-508-7891 and the room number *1979783* to enter the meeting. Please note that the phone lines will be closed during the lunch break, tentatively scheduled from 11:30 am to 12:30 pm. All listeners will need to redial 1-800-508-7891 and the room number *1979783* to rejoin the meeting after lunch. For more information, please visit the project website at www.iom.edu/VaccineAdverseEffects. Any changes regarding the time the afternoon session convenes will be posted on the project website; speaker presentations will also be available the day of the meeting.

The agenda below includes estimated times. The meeting may end early if the speakers do not use all the time alotted.

Committee to Review Adverse Effects of Vaccines
Meeting 2
Wednesday, June 24, 2009
9:00 am - 2:45 pm
Room 101
Keck Center of the National Academies
500 5th Street, NW
Washington, DC 20001

DRAFT AGENDA

9:00 - 9:45 am
Causal Inference
Steven Goodman, M.D., M.H.S., Ph.D.
Professor of Oncology
Division of Biostatistics, Johns Hopkins Kimmel Cancer Center
Departments of Pediatrics, Biostatistics, and Epidemiology
Johns Hopkins Schools of Medicine and Public Health

9:45 - 10:30 am
Biologic Mechanisms: Weighing the Evidence
Douglas L. Weed, M.D., M.P.H., Ph.D.
Founder and Managing Member
DLW Consulting Services, LLC

10:30 - 10:45 am
Break

10:45 - 11:30 am
Multiple Sclerosis
Stephen L. Hauser, M.D.
Professor and Chair, Department of Neurology
University of California, San Francisco

11:30 - 12:30 pm
Lunch
Cafeteria is located on the 3rd Floor

12:30 - 1:15 pm
Molecular Mimicry
Robert Fujinami, Ph.D.
Professor of Neurology and Pathology
University of Utah

1:15 - 2:00 pm
Molecular Mimicry
Madeleine W. Cunningham, Ph.D.
George Lynn Cross Research Professor
Microbiology and Immunology
University of Oklahoma College of Medicine

2:00 - 2:45 pm
Genetic Susceptibility in Vaccine Adverse Effects
Jason H. Moore, Ph.D.
Frank Lane Research Scholar in Computational Genetics
Professor of Genetics
Professor of Community and Family Medicine
Dartmouth Medical School

2:45 pm
Adjourn
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Ellen Wright Clayton (Chair)
Douglas J. Barrett
Martina Bebin
Graham A. Colditz (June 24 only)
Martha Constantine-Paton
Deborah J. del Junco
Betty A. Diamond
S. Claiborne Johnston
Anthony L. Komaroff
B. Paige Lawrence
Hugh A. Sampson
Pauline A. Thomas
Leslie P. Weiner

The following topics were discussed in the closed sessions:

June 24, 2009; 3:45 pm – 5:15 pm
The committee discussed causal inference and the speaker presentations from the open session.

June 25, 2009; 8:30 am – 1:30 pm
The committee conducted the conflict of interest and potential sources bias discussion for a new member, per NRC procedure. The committee discussed their composition and the proposed meeting schedule. The committee discussed how the literature searches will be conducted and assigned workgroups. The committee also outlined items to discuss at the next meeting and proposed possible speakers.

The following materials (written documents) were made available to the committee in the closed sessions:

None.

Date of posting of Closed Session Summary:
July 08, 2009
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Erin Rusch
Contact Email:  vaccinesafety@nas.edu
Contact Phone:  202-334-2077

Agenda
The meeting will be available via conference call. Please dial 1-800-508-7891 and the room number *1979783* to enter the meeting. Please note that the * star key is required before and after the room number. For more information, please visit the project website at www.iom.edu/VaccineAdverseEffects.

Committee to Review Adverse Effects of Vaccines
Meeting 1
April 20, 2009
Room 201
Keck Center of the National Academies
500 5th Street NW
Washington, DC 20001

DRAFT Agenda

1:00 pm
Welcome and Committee Introductions
Ellen Wright Clayton, J.D., M.D.
Committee Chair

1:10 – 1:30 pm
Charge to the Committee
Joyce G. Somsak, M.A.
Associate Administrator
Healthcare Systems Bureau
Health Resources and Services Administration
U.S. Department of Health and Human Services

Rosemary Johann-Liang, M.D.
Chief Medical Officer
National Vaccine Injury Compensation Program
Health Resources and Services Administration
U.S. Department of Health and Human Services

1:30 – 2:00 pm
Discussion about the Charge

2:00 – 3:00 pm
Public Comments (in person, e-mail, and via teleconference)

3:00 pm
Adjourn
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Ellen Wright Clayton (Chair)
Douglas J. Barrett (April 20 only and via teleconference)
Martina Bebin
Graham A. Colditz (April 20 only)
Deborah J. del Junco
Betty A. Diamond
S. Claiborne Johnston
Anthony L. Komaroff
B. Paige Lawrence (April 20 only and via teleconference)
Hugh A. Sampson
Pauline A. Thomas
Leslie P. Weiner

The following topics were discussed in the closed sessions:

April 20, 2009; 8:00 am – 12:00 pm
The committee conducted the conflict of interest and potential sources bias discussion, per NRC procedure, and began discussing their statement of task.

April 20, 2009; 3:00 pm – 5:00 pm
The committee discussed their statement of task, the speaker presentations and public comment from the open session, and the IOM study process.

April 21, 2009; 8:00 am – 1:30 pm
The committee discussed their composition, a preliminary list of adverse effects, and how literature searches should be started. The committee also outlined items to discuss at the next meeting and proposed possible speakers.

The following materials (written documents) were made available to the committee in the closed sessions:

None.

Date of posting of Closed Session Summary:
May 01, 2009
Publication(s) resulting from the event:

-

Publications

  • Publications having no URL can be seen at the Public Access Records Office