Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration (2024)

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Appendix A Committee Member and Staff Biographies COMMITTEE MEMBERS George J. Isham, M.D. M.S. (Chair), is a senior fellow at the HealthPartners Institute and a senior advisor for the Alliance of Community Health Plans. He was HealthPartners’ medical director and chief health officer, responsible for quality of care and health and health care improvement. He was a member of the CDC Task Force on Community Preventive Services and the Agency for Healthcare Research and Quality’s United States Preventive Services Task Force and founding cochair of the National Committee for Quality Assurance’s committee on performance measurement and the National Quality Forum’s Measurement Application Partnership. Dr. Isham is a member of the National Academy of Medicine (NAM). He has an M.D. from the University of Illinois Chicago and an M.S. in preventive medicine and administrative medicine from the University of Wisconsin–Madison. Anne Bass, M.D. (Vice Chair), is a professor of clinical medicine at Weill Cornell Medicine and a practicing rheumatologist at the Hospital for Special Surgery and New York Presbyterian Hospital (Cornell). She was the principal investigator for the 2022 American College of Rheumatology (ACR) Guideline for Vaccinations in Patients with Rheumatic and Musculoskeletal Diseases (RMD) and a member of the core group for the ACR Guidance for COVID-19 Vaccination in Patients with RMD. Dr. Bass is currently the treasurer of the ACR and the Rheumatology Research Foundations. Her clinical research focuses on the autoimmune effects of immune checkpoint inhibitor cancer therapy, particularly inflammatory arthritis. She received her undergraduate degree at Harvard and earned her M.D. and was a resident at Columbia, followed by a rheumatology fellowship at New York University. Alicia Christy, M.D., was the deputy director of reproductive health, Veterans Health Administration. She served as the obstetrics and gynecology department chair and a consultant to the Army Surgeon General. She was a clinical researcher at the National Institutes of Health (NIH), where her research focused primarily on the areas of contraception, treatment of leiomyoma, and health disparities. She has been involved in evidence review for two U.S. Department of Veterans Affairs (VA) and U.S. Department of Defense clinical practice guidelines. She was the coeditor of Contraception and Reproductive Medicine. She held the rank of professor at the Uniformed Services University and adjunct professor at Howard University. Dr. Christy has received the NIH Award of Merit, multiple research awards, the NIH Collaborator Award, a Humanism in Medicine Award, an Excellence in Teaching Award, and a Mentor of the Year Award. She was the chair of the American Society of Reproductive Medicine Health Disparities Special Interest Group and the VA liaison to an American College of Obstetricians and Gynecologists committee. Dr. Christy received her undergraduate degree from PREPUBLICATION COPY—Uncorrected Proofs 311 

312 VACCINE EVIDENCE REVIEW Princeton University, is an Alpha Omega Alpha graduate of Northwestern University School of Medicine, and received an M.A. in health science and clinical research from the Duke University School of Medicine. DeLisa Fairweather, Ph.D., is a professor of medicine, the director of translational research in the Department of Cardiovascular Medicine, and the codirector of research for the EDS Clinic at the Mayo Clinic in Jacksonville, Florida. In addition to an interest in myocarditis, dilated cardiomyopathy, and heart failure, Dr. Fairweather specializes in how sex differences in inflammation caused by environmental exposures, such as viruses, lead to chronic inflammatory diseases, such as autoimmune diseases, cardiovascular disease, cancer, and lung disease. She was a coinvestigator and leader of the Mayo-led Food and Drug Administration (FDA)-funded Expanded Access Program that provided convalescent plasma to patients with COVID-19 during the first year of the pandemic. She was a standing member of the Atherosclerosis and Inflammation of the Cardiovascular System Study Section at NIH for 6 years, and she serves on the Medical Advisory Board for the Myocarditis Foundation. She obtained her Ph.D. at the University of Western Australia in microbiology and immunology and conducted a postdoctoral fellowship at Johns Hopkins University. James Floyd, M.D., M.S., is a physician at Harborview Medical Center, an associate professor of medicine (general internal medicine) and adjunct associate professor of epidemiology at the University of Washington, and an affiliate investigator at Kaiser Permanente Washington Health Research Institute. He has expertise in cardiovascular epidemiology and drug safety, including postmarket surveillance using electronic health data, and is an active investigator in several National Heart, Lung, and Blood Institute (NHLBI)-funded prospective cohort studies and international research consortia. In 2019 he acted as a consultant for Shionogi. 1 Dr. Floyd earned his M.D. from Duke University. He completed a T32 Fellowship in cardiovascular epidemiology at the University of Washington Cardiovascular Health Research Unit, where he is the codirector. Eric J. Hegedus, Ph.D., D.P.T., M.H.Sc., is an orthopedic physical therapist and a professor with the Tufts University School of Medicine. He was a professor at High Point University, where he developed its Doctor of Physical Therapy (D.P.T.) program, and an associate professor at Duke University. He has more than 30 years of clinical experience and has taught in the United States and abroad. Dr. Hegedus answers clinical questions in the orthopedic and sports prevention, diagnosis, and rehabilitation realm and translates the findings to clinical practice. He has been a member of the American Physical Therapy Association since 1991 and received its national James A. Gould Teaching Award, given annually to the single most deserving teaching professor of musculoskeletal physical therapy. Dr. Hegedus earned a Ph.D. from the University of Ulster, a D.P.T. from Slippery Rock University, and an M.H.Sc. from Duke University. John E. (Jed) Kuhn, M.D., M.S., is the Kenneth D. Schermerhorn Professor in the Department of Orthopedic Surgery in the Vanderbilt University Medical Center and the director of the Sports Medicine and Shoulder Surgery Division; he joined in 2003 to build that division. Dr. Kuhn is the founder of the Multicenter Orthopedic Outcomes Network Shoulder Group—a multicenter 1 Dr. Floyd’s biography was updated since the release of the report to disclose his prior relationship with Shionogi. PREPUBLICATION COPY—Uncorrected Proofs 

APPENDIX A 313 research collaboration designed to study conditions about the shoulder. He is the president elect for the American Shoulder and Elbow Surgeons and the deputy editor in chief for the Journal of Shoulder and Elbow Surgery. He earned his M.D. and was a resident in orthopedic surgery at the University of Michigan and then a fellow in sports medicine and shoulder surgery at the Steadman Howking Clinic in Vail, Colorado. He returned as a faculty member at the University of Michigan for 8 years. Chandy C. John, M.D., M.S., holds the Ryan White Endowed Chair in Pediatric Infectious Diseases and is the director of the Ryan White Center for Pediatric Infectious Diseases and Global Health at Indiana University. He investigates why children develop, survive, or die from malaria and studies ways to prevent malaria and other infections in children with sickle cell disease. Dr. John is a cochair of the Thrasher Research Fund Scientific Advisory Committee and a member of the Fogarty International Center Advisory Board, the American Academy of Pediatrics Committee on Infectious Diseases, and the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices Polio Working Group. Dr. John received the Bailey K. Ashford Medal from the American Society of Tropical Medicine and Hygiene in 2011 and was its president in 2019. He earned his M.D. and was a resident in internal medicine and pediatrics at the University of Michigan and completed fellowship training in pediatric infectious diseases at Case Western Reserve University. Evan Mayo-Wilson, Ph.D., M.P.A., is an associate professor of epidemiology at the University of North Carolina Gillings School of Global Public Health. His research aims to improve public health and to advance methods for conducting health and behavioral research. He focuses on (1) evaluating the effectiveness of pharmacological and behavioral interventions, (2) improving methods for clinical trials and systematic reviews, and (3) developing methods and interventions to increase research transparency and openness. Dr. Mayo-Wilson serves on several editorial boards, including as the associate editor for systematic reviews for the American Journal of Public Health. He has contributed to several reporting guidelines and to guidance for increasing transparency and openness. Dr. Mayo-Wilson completed his D.Phil. in the Department of Social Policy and Intervention at University of Oxford. He also has degrees in public administration (M.P.A., University of Pennsylvania) and evidence-based intervention (M.Sc., University of Oxford). Thomas Ortel, M.D., Ph.D., the chief of hematology and a professor of medicine and pathology at Duke University, is nationally and internationally recognized for his clinical and research expertise in hemostatic and thrombotic disorders. His primary interests focus on rare antibody- mediated thrombotic disorders, including antiphospholipid antibody syndrome and heparin- induced thrombocytopenia, and developing and managing novel antithrombotic therapies. His experience conducting prospective, randomized, multicenter clinical trials and interest in rare thrombotic disorders resulted in becoming the study chair for the NHLBI-sponsored Accelerating COVID-19 Therapeutic Interventions and Vaccines Post-Hospital Thrombosis Prevention Study, investigating the use of extended thromboprophylaxis to prevent thromboembolic complications. Dr. Ortel has been the site principal investigator at Duke University for studies funded by Takeda Pharmaceutical Company on the treatment of patients with congenital and acquired thrombotic thrombocytopenic purpura since 2020, and, previously, a study on acquired hemophilia, during which he also received compensation for a steering PREPUBLICATION COPY—Uncorrected Proofs 

314 VACCINE EVIDENCE REVIEW committee meeting. As of December 2023, he is serving as a consultant to Takeda on the steering committee for the phase 3 study using recombinant ADAMTS13 in patients with acquired thrombotic thrombocytopenic purpura. In 2023 he reviewed the results of a clinical trial for a drug to treat hemophilia, for which he was compensated by Sanofi. 2 During the past year, he collaborated with colleagues at CDC on the Clinical Immunization Safety Assessment Project related to the development of TTS after COVID-19 vaccination. He completed a combined M.D./Ph.D. program at Indiana University in 1985, followed by internship and residency training in internal medicine and fellowship training in hematology and medical oncology, both at Duke University. Nicholas S. Reed, Au.D., Ph.D., is an assistant professor in the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health with a joint appointment in the Department of Otolaryngology—Head and Neck Surgery (Audiology) at the Johns Hopkins University School of Medicine. He is the director of the Audiology Core at the Johns Hopkins Cochlear Center for Hearing and Public Health, where he oversees integrating and managing hearing measures in multiple large epidemiological cohort studies and clinical trials. His research focuses on the association of hearing loss among older adults with healthy aging outcomes, including cognitive decline and health resource use, the impact of hearing intervention on health outcomes, and novel models of hearing care delivery. He earned the Early Career Research Award in 2021 from the American Auditory Society. Dr. Reed received his Ph.D. in audiology from Towson University and completed his audiology clinical fellowship at Georgetown University Hospital. He sat on the National Academies’ Committee on Evaluating Hearing Loss for Individuals with Cochlear Implants. Andy S. Stergachis, Ph.D., B.Pharm., is a professor of pharmacy and global health and the director of the Global Medicines Program and the associate dean for research, graduate studies, and new initiatives, School of Pharmacy, University of Washington (UW). He is the director of the UW Biomedical Regulatory Affairs Program and an adjunct in the UW Departments of Health Metrics and Evaluation, Epidemiology, and Health Systems and Population Health. He is an author of publications in areas such as pharmacovigilance, pharmacoepidemiology, pharmaceutical services, and clinical epidemiology. He has developed and evaluated novel approaches for safety surveillance of essential medicines and vaccines. A licensed pharmacist, he served as the editor in chief of the Journal of the American Pharmacists Association for 6 years, until 2019. He is a member of the CEPI Maternal Immunization Working Group (formerly via COVAX). Dr. Stergachis is an elected member of the NAM, a fellow of the American Pharmacists Association, and a fellow of the International Society for Pharmacoepidemiology. He received a Ph.D. in social and administrative pharmacy from the University of Minnesota. Michel Toledano, M.D., is an assistant professor of neurology and the medical director for inpatient neurology services at the Mayo Clinic in Rochester, Minnesota. He completed his neurology residency at the Mayo Clinic, where he pursued a fellowship in multiple sclerosis. He then undertook a fellowship in neuroinfectious diseases at Chelsea and Westminster Hospital in 2 Dr. Ortel’s biography was updated since the release of this report to disclose his role as a site principal investigator for studies at Duke University funded by Takeda Pharmaceutical Company related to treatment of patients with congenital and acquired thrombotic thrombocytopenic purpura and hemophilia, as well as service on steering committees during the course of the study. PREPUBLICATION COPY—Uncorrected Proofs 

APPENDIX A 315 London, United Kingdom. His research interests include improving care delivery models for hospitalized neurology patients and optimizing diagnostic test use, especially for patients presenting with encephalitis and other infectious or neuroinflammatory syndromes. Dr. Toledano earned his M.D. from Ben-Gurion University of the Negev. Robert B. Wallace, M.D., M.Sc., is an emeritus professor of epidemiology and internal medicine at the University of Iowa (UI) College of Public Health. He was trained in general internal medicine. After his residency, he worked at CDC, where he specialized in the epidemiology and control of several communicable and vaccine-preventable diseases, including measles, mumps and rubella, smallpox, and agents more common in tropical countries, and the infectious causes of chronic illnesses, such as some cancers. During his long career at UI, he researched the prevention and control of several chronic illnesses of older people, such as cardiovascular disease, cancer, and other disabling conditions, including Alzheimer’s disease and other neurodegenerative conditions. He received the NAM Walsh McDermott Medal in recognition for his distinguished service, having participated in more than 20 National Academies’ consensus committees, and is an elected member of NAM. Dr. Wallace has an M.D. from Northwestern University in Illinois and an M.Sc. from the State University of New York at Buffalo. Ousseny Zerbo, Ph.D., is a research scientist II at the Vaccine Study Center at Kaiser Permanente Northern California, Division of Research. He is an epidemiologist with expertise in infectious diseases, neurodevelopmental disorders (autism), vaccine safety, and effectiveness. He is the principal investigator on two NIH-funded projects to investigate the effectiveness of influenza vaccination, COVID-19 vaccination during pregnancy, and infant risk of influenza and COVID-19. He holds a Ph.D. in epidemiology from the University of California, Davis, and a B.S. in biological sciences from the Université de Ouagadougou. NAM FELLOW Inmaculada (Inma) Hernandez, Ph.D., is an associate professor with tenure at the University of California, San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences. She has authored more than 100 scientific articles, including first-authored papers in JAMA, JAMA Internal Medicine, and Annals of Internal Medicine, among other leading journals. Her research has been covered by media worldwide and featured by main media outlets, including New York Times, Washington Post, NPR, CNN, Forbes, and BBC. Dr. Hernandez has studied extensively the underuse of anticoagulation in stroke prevention in patients with cardiac arrhythmias. She is the principal investigator of an R01 award from NIH to study the impact of the COVID-19 pandemic on patients with cardiovascular disease. She has made important contributions to the study of pharmaceutical pricing. In 2020, she was the first to quantify the role of manufacturer discounts in rising drug prices. In 2020–2021, Dr. Hernandez led a group of investigators evaluating geographic access to COVID-19 vaccine administration locations. Their analyses informed the Pennsylvania Department of Health vaccine distribution in medically underserved areas. Dr. Hernandez received her Pharm.D. from the University of Navarra in Spain, her M.S. in health economics and pharmacoeconomics from the University Pompeu i Fabra in Spain, and her Ph.D. in health services research and policy from the University of Pittsburgh. She was on the Forbes 30 under 30 list in 2018, and in 2021, she became the first pharmacist to be recognized PREPUBLICATION COPY—Uncorrected Proofs 

316 VACCINE EVIDENCE REVIEW with the Academy Health Alice S. Hersh Emerging Leader Award. She is a fellow of the American College of Cardiology and the American Heart Association. STAFF Kathleen Stratton, Ph.D., began her career at the National Academies in 1990 in the Institute of Medicine. She has spent most of her time with the Board on Population Health and Public Health Practice. She has staffed committees addressing vaccine safety and development, pandemic preparedness, environmental and occupational health, drug safety, clinical prevention research, and tobacco control. She was given the IOM Cecil Research Award for sustained contributions to vaccine safety and made a staff scholar in 2005. She received a B.A. in natural sciences from Johns Hopkins University and a Ph.D. in pharmacology and toxicology from the University of Maryland at Baltimore. She conducted postdoctoral research in the Department of Neuroscience at the Johns Hopkins University School of Medicine. Ogan K. Kumova, Ph.D., is a program officer for vaccine safety at the National Academies in the Health and Medicine Division (HMD). Prior to joining the National Academies, he was a research fellow at FDA’s Office of Vaccine Research and Review, where he worked on developing vaccines for infectious diseases. During his time at FDA, Dr. Kumova was a coinvestigator on grants evaluating the safety and immunogenicity of vaccine adjuvants and developing vaccines for meningococcal and gonococcal infections. He obtained his Ph.D. in immunology from the Drexel University College of Medicine in Philadelphia, Pennsylvania. In his graduate work, Dr. Kumova studied neonatal immune responses and modifiable risk factors for respiratory viral infections and collaborated with several labs, including Wistar Cancer Institute, to develop a DNA-based HIV vaccines. He holds a B.S. in biochemistry and bioinformatics from the University of the Sciences in Philadelphia and an M.S. in clinical infectious diseases from Drexel University. Dara Rosenberg, M.P.H., is an associate program officer in HMD on the Board of Population Health and Public Health Practice. Before joining the National Academies, Ms. Rosenberg was an epidemiologist at a local health department. She has experience with communicable disease investigations, public health emergency preparedness, and data analysis, specifically with STI/HIV and COVID-19 data. She completed her B.S. in health sciences at the New York Institute of Technology and has an M.P.H. in epidemiology from The George Washington University. Olivia Loibner, B.A., is a senior program assistant in HMD on the Board of Population Health and Public Health Practice. While at the National Academies, she has contributed to the Review of the Department of Veterans Affairs Presumption Decision Process and workshops on health equity. She received her B.A. in international studies from the American University School of International Service. Rose Marie Martinez, Sc.D., is the senior director of the Board on Population Health and Public Health Practice (1999–present) at the National Academies. The board conducts evidence- based studies that help shape health policy at the federal, state, and local levels. Dr. Martinez was a senior health researcher at Mathematica Policy Research (1995–1999), where she conducted PREPUBLICATION COPY—Uncorrected Proofs 

APPENDIX A 317 health policy research. Dr. Martinez is a former assistant director for health financing and policy with the U.S. General Accounting Office, where she directed evaluations and policy analysis in the area of national and public health issues (1988–1995). Her experience also includes 6 years directing research studies for the Regional Health Ministry of Madrid, Spain (1982–1988). Dr. Martinez received a D.Sc. from the Johns Hopkins University School of Hygiene and Public Health. PREPUBLICATION COPY—Uncorrected Proofs