Vaccine Risk Monitoring and Evaluation at the Centers for Disease Control and Prevention

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The Centers for Disease Control and Prevention's (CDC) Immunization Safety Office (ISO) is responsible for studying vaccine risks once vaccines are administered to the public. During the COVID-19 pandemic, ISO played a central role in vaccine safety evaluation.

At the request of the CDC, the National Academies convened an expert committee to assess the ISO's statistical and epidemiological methods in vaccine risk monitoring and evaluation, including processes designed to detect, evaluate, and report potential problems associated with COVID vaccines. The committee also evaluated CDC's external communication strategies and provided recommendations to sustain and enhance ISO's vaccine risk monitoring and communication systems. The resulting report presents the committee's conclusions and recommendations.

Additional materials

Conclusions and Recommendations

Publication information

252 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-53979-X
ISBN Ebook: 0-309-59410-3
DOI: https://doi.org/10.17226/29240

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National Academies of Sciences, Engineering, and Medicine. 2025. Vaccine Risk Monitoring and Evaluation at the Centers for Disease Control and Prevention. Washington, DC: The National Academies Press.

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Jane E. Henney

Jane E. Henney, M.D., (Chair) has had a distinguished career in academia, government service, and in the governance of both corporate and not-for-profit organizations. Her government service began at the National Cancer Institute (NCl) where she served as Deputy Director. She served as Deputy Commissioner for Operations at the FDA and in 1998 she was confirmed as Commissioner. She has led two major public Academic Health Centers: the University of New Mexico and the University of Cincinnati. She was elected to the National Academy of Medicine (NAM) membership in 2000. She has chaired several consensus studies and served on and chaired the NAM Membership Committee. In 2014, she was appointed as NAM Home Secretary and in 2018 was the first elected Home Secretary serving until 2020. Dr. Henney received her M.D. degree in 1973 from Indiana University School of Medicine and her training in oncology was completed at M.D. Anderson and NCI. She served on the Board of AmerisourceBergen and has residual financial holdings from this role. She is currently the Chair of the University of Kansas Advancement Committee.

Denise H. Chrysler

Denise Chrysler, J.D., served as the Director of the Network for Public Health Law’s Mid-States Region for over twelve years. She recently retired from this position and now serves as a Senior Advisor to the Network. Through the Network, she worked on the IZ Gateway project, a CDC-funded effort that facilitates exchange of immunization information with Immunization Information Systems. Prior to joining the Network, Ms. Chrysler provided legal services to Michigan’s state health department regarding communicable disease, immunization, environmental public health, public health research, privacy, health information exchange, and emergency legal preparedness and response. She received the 2019 Roy J. Manty Distinguished Service Award for contributions to public health in Michigan. Ms. Chrysler previously served on her local board of health and was co-chair of the Public Health Law Subcommittee of the Council of State and Territorial Epidemiologists. She also served on the National Committee on Vital and Health Statistics. Ms. Chrysler graduated from the University of Michigan Law School and is a licensed attorney in Michigan.

Lawrence Deyton

Lawrence Deyton, M.S.P.H., M.D., is the Murdock Head Professor of Medicine and Health Policy and, from 2014 until July 1, 2023, was the Senior Associate Dean for Clinical Public Health at The George Washington University’s School of Medicine and Health Sciences. Prior to joining the GW faculty in 2014, he served in leadership positions at several federal agencies, including as the founding director of the Center for Tobacco Products at the U.S. Food and Drug Administration (FDA). Prior to joining FDA, Dr. Deyton held several leadership positions at the U.S. Department of Veterans Affairs (VA). He oversaw VA’s public health programs, including environmental hazards and public health surveillance programs, women’s health, occupational health, and emergency preparedness and responses of VA’s health system. In 2019, he received the James Bruce Award for Distinguished Contributions in Preventive Medicine by the American College of Physicians. He earned his M.D. from The George Washington University and his M.S.P.H. at the Harvard School of Public Health. Dr. Deyton has served on several National Academies of Sciences, Engineering, and Medicine (NASEM) studies. He received his M.D. from the George Washington University School of Medicine.

Francisco García

Francisco García, M.D., MPH, is the Chief of Staff to the President of the University of Arizona and is a Professor Emeritus of Professor of Public Health. Until January of 2025 he was the Deputy County Administrator and Chief Medical Officer for Pima County, Arizona where he oversaw the departments of Health, Behavioral Health, Environmental Quality. Pima Animal Care Center, and Community & Workforce Development, the offices of Emergency Management, Medical Examiner and Digital Equity as well as the Pima County Libraries. Prior to entering government in 2013, Dr. García achieved the rank of tenured Distinguished Outreach Professor of Obstetrics and Gynecology and Public Health. During his tenure, he served in a variety of leadership roles including as the Director of the University of Arizona Center of Excellence in Women’s Health, Chair of the Section of Family and Child Health of the Mel & Enid Zuckerman College of Public Health, and Director of the Cancer Disparities Institute of the Arizona Cancer Center. Dr. García was elected to the National Academy of Medicine in 2023. He has served on the National Academies of Science, Engineering and Medicine Committee on Evidence-Based Practices for Public Health Emergency Preparedness and Response, as well as the Roundtable on Health Equity and the Committee on Preventive Services for Women. He is a former member of the U.S. Preventive Services Task Force. He received an MD from the University of Arizona and an MPH from Johns Hopkins University.

Krishika Graham

Krishika A. Graham, M.D., M.P.H. is the Unit Chief for Vaccine Preventable Disease Surveillance with the NYC Department of Health and Mental Hygiene’s Bureau of Immunization where she oversees vaccine preventable disease surveillance. The Bureau receives funding from CDC to support coordination for enhanced vaccine preventable and respiratory diseases surveillance. She has served as the vaccine safety branch director during NYC’s monkeypox outbreak response, leading an evaluation of vaccine reactogenicity and safety of Jynneos vaccine using a survey of vaccine recipients in New York City's immunization registry during a period of expanded use. She also previously led outreach and enrollment of Federally Qualified Health Centers and independent pharmacies in the NYC COVID-19 Vaccine Program. She is a Board-Certified Pediatrician and Preventive Medicine physician. She received her M.D. from the University of Virginia and her Master of Public Health from the CUNY Graduate School of Public Health & Health Policy.

Marie R. Griffin

Marie R. Griffin, M.D., M.P.H. is Professor of Health Policy, Emerita at Vanderbilt University School of Medicine. Her research focused on the safety and effectiveness of drugs and vaccines, and the burden of vaccine preventable diseases. She developed novel methods to quantify the medical care burden of common respiratory viruses in both children and adults. Dr. Griffin recently served on the National Institute of Allergy and Infectious Diseases (NIAID) Data and Safety Monitoring Committee for COVID-19 Vaccine Clinical Trials. She is a current member of the Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee, and the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) work group on RSV vaccines. She is Vice-Chair of the Metro Nashville Board of Health. Dr. Griffin is the recipient Grant W. Liddle Award for Outstanding Contributions to Research at Vanderbilt University Medical Center, the Association for Clinical and Translational Science Distinguished Investigator Award for Translation from Clinical Use into Public Benefit and Policy, the Mary Jane Werthan Award for Advancement of Women at Vanderbilt, and the Elaine Sanders-Bush Award for Mentoring Graduate and/or Medical Students in Research Settings at Vanderbilt. Dr. Griffin has previously served on NASEM committees relating to vaccine safety. She received her M.P.H. from Johns Hopkins School of Hygiene and Public Health, and her M.D. from Georgetown University Medical School.

Perry N. Halkitis

Perry N. Halkitis, Ph.D., is Dean, Hunterdon Professor of Public Health & Health Equity, and Distinguished Professor of Biostatistics & Epidemiology at the Rutgers School of Public Health. He is an infectious disease epidemiologist, applied statistician, and public health psychologist. For three decades, the focus of his research has been on the emergence, prevention, and treatment of infectious diseases in sexual, gender, and/or racial and ethnic minority populations. He is the founder and Director of the Center for Health, Identity, Behavior & Prevention Studies (CHIBPS). He is Professor Emeritus at the College of Global Public Health at New York University. He is an elected fellow of The New York Academy of Medicine, The Society of Behavioral Medicine, The American Epidemiological Society, The European Academy of Translational Medicine, the College of Physicians of Philadelphia, and four divisions of the American Psychological Association. He is the Editor in Chief of Behavioral Medicine since 2013 and is the Founding Editor in Chief of Annals of LGBTQ Public and Population Health. Dr. Halkitis serves on the Board of Directors of the Association for School and Programs of Public Health (as chair in 2023-24) and the Hyacinth Foundation. He also serves on the advisory boards of both the New Jersey Public Health Advisory Committee and the Behavioral Risk Factor Survey Advisory Committee. Dr. Halkitis holds degrees in epidemiology, applied statistics, psychology, and education from the City University of New York.

Sonia Hernández-Díaz

Dr. Sonia Hernández-Díaz, MD, DrPH is Professor of Epidemiology at the Harvard T.H. Chan School of Public Health, where she serves as Director of the Pharmacoepidemiology & Real-World Evidence (RWE) Program. Her research focuses on examining the safety of pharmaceuticals using observational data, with a special interest on pregnant women and their infants. Another group of research activities concerns the application of innovative methodologic concepts to increase the validity of non-randomized studies. She helped develop methods for emulating trials to evaluate the effectiveness and safety of COVID-19 vaccines during pregnancy and collaborated with the Covid-19 Vaccines International Pregnancy Exposure Registry, under the aegis of Preregistry. She receives salary support for work on the Massachusetts General Hospital (MGH) Anti-Epileptic Drugs pregnancy registry funded by multiple pharmaceutical companies, including Janssen. She also serves as a compensated member of the Scientific Committee for the MGH Antipsychotics drug registry. Her research on the effects of constipation drugs on pregnancy is supported by Takeda Pharmaceuticals. Previously, she was compensated for providing consulting services to J&J, and currently consults for Moderna and Roche for work unrelated to vaccines. Dr. Hernández-Díaz has served as chair for the Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration (FDA), as a reviewer for the NICHD Pregnancy & Neonatology Study Section, and as member of the Teratogenic Information Services (TERIS) Advisory Board. She was elected President of the Society for Perinatal and Pediatric Epidemiology in 2014 and President of the International Society for Pharmacoepidemiology in 2015. Dr. Hernández-Díaz received her MD from the Autonoma University of Madrid Medical School and her DrPH in Epidemiology from the Harvard School of Public Health.

Ali S. Khan

Ali S. Khan, M.D., is the Richard Holland Presidential Chair and Dean of the College of Public Health at the University of Nebraska Medical Center. He is a former Assistant Surgeon General with the US Public Health Service. His career has focused on health security, global health, climate change, and emerging infections. He completed a 23-year career as a senior director at the Centers for Disease Control and Prevention, where he led and responded to numerous high profile domestic and international public health responses. Dr. Khan was one of the main architects of CDC’s national health security program with an early focus on preparations for acquisition and use of smallpox and anthrax vaccines. He frequently speaks about and publishes on improving childhood and adult immunization access and addressing vaccine hesitancy. He is the author of The Next Pandemic: On the Front Lines Against Humankind’s Gravest Dangers. Dr. Khan has previously served on several NASEM committees, including the Committee on Best Practices in Assessing Morbidity and Mortality Following Large-Scale Disasters. He received his M.D. from Downstate Medical University, completed a med-peds residency at the University of Michigan, followed by his M.P.H. from Emory University and M.B.A. from University of Nebraska-Omaha.

Daniella Meeker

Daniella Meeker, Ph.D. is an Associate Professor in the Section of Biomedical Informatics and Data Science and the Chief Research Information Officer at Yale University School of Medicine and Yale New Haven Health System. Dr. Meeker’s expertise is in applications of behavioral economics to improve quality of care, analysis of claims and electronic medical record data, and managing large, multi-institutional EHR-integrated studies. Dr. Meeker has received the Behavioral Publication Award for Innovation in Behavioral Policy (2019), Scientific Program Committee AMIA (2015), Merkin Scholarship for Neuroscience and Policy (2015), Robert Brook Scholarship Award (2013), and Distinguished Fellow with Roybal Center for Health Policy Simulation (2012). Dr. Meeker received her Ph.D. in Computation and Neural Systems from the California Institute of Technology in Pasadena, CA.

Glen Nowak

Glen Nowak, Ph.D., is a professor, an Associate Dean for Research and Graduate Studies, and co-director of a Center for Risk & Health Communication in the Grady College of Journalism & Mass Communication at the University of Georgia. He is a national and internationally known expert in health and risk communication research and training related to infectious and vaccine-preventable diseases, crisis, and emergency risk communication and vaccination acceptance and decision making. Prior to re-joining the University of Georgia (UGA) faculty in January 2013, Dr. Nowak spent 14 years at the U.S. Centers for Disease Control and Prevention (CDC), including six years as the Communications Director for the National Immunization Program and six years as the agency’s Director of Media Relations. Dr. Nowak is co-editor of the recently published book Advancing Crisis Communication Effectiveness. In the past he provided presentations on vaccine hesitancy and acceptance in multiple settings, including with a Janssen Advisory Board in 2020. He has served as an expert on issues related to vaccine confidence and safety with the National Vaccine Advisory Committee and the Council for Quality Health Communication, among others. Dr. Nowak received his Bachelor of Science degree from the University of Wisconsin-Milwaukee, with majors in economics and communications. He has an M.A. degree in journalism and a Ph.D. in the field of mass communications from the University of Wisconsin-Madison.

Olayinka Shiyanbola

Olayinka Shiyanbola, Ph.D., B.Pharm., is Charles R. Walgreen Jr. Professor in the Department of Clinical Pharmacy at the University of Michigan College of Pharmacy. Dr. Shiyanbola’s research examines patient perceptions and roles in medication use and its impact on medication adherence, health literacy and the elimination of health disparities. Specifically, Dr. Shiyanbola studies the perceptions of illness and medicines among marginalized populations. She interweaves patient perspectives into the implementation of tailored patient-centered medication use interventions. She utilizes sociobehavioral and health psychology theories in her studies and employs qualitative, quantitative, and mixed methods approaches in her work. As an NIH scholar/fellow, Dr. Shiyanbola received training in health disparities research, randomized behavioral clinical trials, and mixed methods. She was a Society of Behavioral Medicine Leadership Fellow and is an appointed member of the National Academies of Science, Engineering, and Medicine Roundtable on Health Literacy. She received her B.Pharm from the University of Ibadan in Nigeria and her Ph.D. in Pharmaceutical Socioeconomics from the University of Iowa in Iowa City.

Lillie Williamson

Lillie D. Williamson, Ph.D., is Assistant Professor in the Department of Communication Arts at the University of Wisconsin at Madison. Dr. Williamson’s research broadly examines the ways in which lived experiences intersect with and can influence health communication. Much of her work investigates the interactions between communication within and outside the clinical context and medical mistrust, particularly for Black Americans. Her current projects explore communication about medical racism, shared trust between clinicians and patients, and the creation of community-driven, culturally responsive science communication strategies and messages. Dr. Williamson holds a B.S. in biology and psychology from the University of North Carolina at Chapel Hill and an M.A. and Ph.D. in communication from the University of Illinois at Urbana-Champaign.

Consensus

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The Centers for Disease Control and Prevention's (CDC) Immunization Safety Office (ISO) is responsible for studying vaccine risks once vaccines are administered to the public. During the COVID-19 pandemic, ISO played a central role in vaccine safety evaluation.

At the request of the CDC, the National Academies convened an expert committee to assess the ISO's statistical and epidemiological methods in vaccine risk monitoring and evaluation, including processes designed to detect, evaluate, and report potential problems associated with COVID vaccines. The committee also evaluated CDC's external communication strategies and provided recommendations to sustain and enhance ISO's vaccine risk monitoring and communication systems. The resulting report presents the committee's conclusions and recommendations.

Additional materials

Conclusions and Recommendations

Publication information

252 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-53979-X
ISBN Ebook: 0-309-59410-3
DOI: https://doi.org/10.17226/29240

Suggested citation

National Academies of Sciences, Engineering, and Medicine. 2025. Vaccine Risk Monitoring and Evaluation at the Centers for Disease Control and Prevention. Washington, DC: The National Academies Press.

Import this citation to:

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Review of CDC COVID-19 Vaccine Safety Research and Communications

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