Advancing the Science of Vaccine Safety During the Coronavirus Disease 2019 (COVID-19) Pandemic and Beyond: Launching an International Network of Special Immunization Services.

Within 2 years after the start of the coronavirus disease 2019 (COVID-19) pandemic, novel severe acute respiratory syndrome coronavirus 2 vaccines were developed, rigorously evaluated in large phase 3 trials, and administered to more than 5 billion individuals globally. However, adverse events of special interest (AESIs) have been described post-implementation, including myocarditis after receipt of messenger RNA (mRNA) vaccines and thrombosis with thrombocytopenia syndrome after receipt of adenoviral vector vaccines. AESIs are rare (<1 to 10/100 000 vaccinees) and less frequent than COVID-19 complications, though they have associated morbidity and mortality. The diversity of COVID-19 vaccine platforms (eg, mRNA, viral vector, protein) and rates of AESIs both between and within platforms (eg, higher rate of myocarditis after mRNA-1273 vs BNT162b2 vaccines) present an important opportunity to advance vaccine safety science. The International Network of Special Immunization Services has been formed with experts in vaccine safety, systems biology, and other relevant disciplines to study cases of AESIs and matched controls to uncover the pathogenesis of rare AESIs and inform vaccine development.
Competing Interests: Potential conflicts of interest. K. A. T. reports funding from the Canadian Institutes of Health Research and Public Health Agency of Canada for safety evaluation of coronavirus disease 2019 (COVID-19) vaccines and grants from GlaxoSmithKline outside the submitted work. O. L. is a named inventor on patents relating to adjuvants and human in vitro systems that predict vaccine safety assessments and reports grants for the Precision Vaccines Program from the Boston Children’s Hospital Department of Pediatrics and the Chief Scientific Office and consulting fees from Moody’s analytics. C. B. C. reports grants and contracts from the NIH and CDC for vaccine clinical trials including NIH Vaccine and Treatment Evaluation Unit (including the Moderna COVE study, Janssen ENSEMBLE study, Moderna KidCOVE study) and CDC Clinical Immunization Safety Assessment Network; grants from Merck; royalties for contributions to the UpToDate program; multiple small honoraria for lectures on COVID-19 vaccines and other vaccines; consultation fees from Altimmune (COVID-19 vaccine development), Janssen (respiratory syncytial virus vaccine development), Astellas (clinical trial data and safety monitoring board), Horizon Pharma (consultation related to care of children with chronic granulomatous disease), and Vir (influenza monoclonal antibody development); payment for expert testimony from multiple legal firms for general medical malpractice; US patent 10,981,979 B2; and serving as the president of the Pediatric Infectious Diseases Society. K. G. reports grants from the Task Force for Global Health and the CDC via the Global Vaccine Data Network for sentinel surveillance and personal fees from the CDC via the Global Vaccine Data Network for vaccine safety training materials. C. L. C. reports a grant from GAVI, the Vaccine Alliance, for vaccine safety surveillance and serving as a member of the Brighton Collaboration Scientific committee and the Institutional Biosafety committee. G. A. P. reports funding from ICW Ventures and the NIH (AI 48793, AI 33144, and AI 132348); consulting fees from Contec, Inc, 3D Communications, AstraZeneca UK Ltd, Bank of America Corporation, Eli Lily and Company, Emergent BioSolutions, Exelixis Inc, ExpertConnect, Genevant Sciences, Inc, GlaxoSmithKline, Janssen Global Services, LLC, Janssen Research & Development, LLC, Medicago USA, Medscape, LLC, Merck, Regeneron Pharmaceuticals Inc, Sanofi Pasteur SA, Syneos Health, and Vyriad; and participation on a data safety monitoring or advisory board for 3D Communications, AstraZeneca UK Ltd, Bavarian Nordic A/S, Dynavax Technologies, Genentech, Inc, GlaxoSmithKline, Janssen Global Services, LLC, and Janssen Pharmaceuticals, Inc. N. C. reports a Medical Research Future Fund grant and serving on a government advisory committee for the Australian Technical Advisory Group on Immunisation-ATAGI. B. C. reports a CDC grant and serving as a board member for the Rare Disease Foundation. R. T. C. reports grants from the Coalition for Epidemic Preparedness and Innovation and the CDC; travel support from Elsevier; honoraria payments from the Brighton Collaboration; serving as the scientific director at the Brighton Collaboration; and serving as a co-lead on the COVAX Vaccine Safety Working Group. All remaining authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
(© The Author(s) 2022. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.)