The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety

Vaccine - Tập 39 - Trang 2712-2718 - 2021
Steven B. Black1, Barbara Law1, Robert T. Chen1, Cornelia L. Dekker1, Miriam Sturkenboom2, Wan-Ting Huang1, Marc Gurwith1, Greg Poland3
1The Brighton Collaboration, a program of the Task Force for Global Health, Decatur, Georgia USA
2University of Utrecht, Netherlands
3The Mayo Clinic, United States

Tài liệu tham khảo

Dudley, 2020, The state of vaccine safety science: systematic reviews of the evidence, Lancet Infect Dis, 10.1016/S1473-3099(20)30130-4 Rid, 2020, The Ethics of Continuing Placebo in SARS-CoV-2 Vaccine Trials, JAMA https://pubmed.ncbi.nlm.nih.gov/12456938/. https://pubmed.ncbi.nlm.nih.gov/14585633/. https://pubmed.ncbi.nlm.nih.gov/9326478/. COVID, CDC, and Response Team. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine—United States, December 14–23, 2020. Morbidity and Mortality Weekly Report 70.2, 2021: 46. Torjesen, Ingrid. Covid-19: Norway investigates 23 deaths in frail elderly patients after vaccination. 2021. Whitaker, 2009, The methodology of self-controlled case series studies, Stat Methods Med Res, 18, 7, 10.1177/0962280208092342 Dodd CN, Willame C, Sturkenboom M. Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines EUPAS37273 http://www.encepp.eu/encepp/viewResource.htm?id=37274. https://www.globalvaccinedatanetwork.org. Remschmidt, 2015, Frequency and impact of confounding by indication and healthy vaccinee bias in observational studies assessing influenza vaccine effectiveness: a systematic review, BMC Infect Dis, 15, 1, 10.1186/s12879-015-1154-y Kuitunen, 2020, Effect of social distancing due to the COVID-19 pandemic on the incidence of viral respiratory tract infections in children in Finland during early 2020, Pediatr Infect Dis J, 39, e423, 10.1097/INF.0000000000002845 https://vac4eu.org/covid-19-vaccine-monitoring/. Lieu Tracy A, Kulldorff Martin, Davis Robert L, Lewis Edwin M, Weintraub Eric, Yih Katherine, et al., Vaccine Safety Datalink Rapid Cycle Analysis Team. Real-time vaccine safety surveillance for the early detection of adverse events. Medical Care 2007:S89–S95. Takii Toru, Satoshi Yasuda, Jun Takahashi, Kenta Ito, Nobuyuki Shiba, Kunio Shirato, et al., MIYAGI-AMI Study Investigators. Trends in acute myocardial infarction incidence and mortality over 30 years in Japan. Circulation J. 2010: 0911240524–0911240524. Yeh, 2010, Population trends in the incidence and outcomes of acute myocardial infarction, N Engl J Med, 362, 2155, 10.1056/NEJMoa0908610 Black, 2009, Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines, The Lancet, 374, 2115, 10.1016/S0140-6736(09)61877-8 Michelson, 2018, Trends in severe pediatric emergency conditions in a National Cohort, 2008 to 2014, Pediatr Emerg Care, 16, 16 Lin, 2008, Increasing anaphylaxis hospitalizations in the first 2 decades of life: New York State, 1990–2006, Ann Allergy Asthma Immunol, 101, 387, 10.1016/S1081-1206(10)60315-8 Yang, 2017, True rise in anaphylaxis incidence: Epidemiologic study based on a national health insurance database, Medicine, 96, e5750, 10.1097/MD.0000000000005750 Nemet, 2015, Considerations and complications after Bells’ palsy, J Clin Neurosci, 22, 1949, 10.1016/j.jocn.2015.04.030 Katusic, 1986, Incidence, clinical features and prognosis in Bells palsy, Rochester, Minnesota. 1968-1982, Ann Neurol, 20, 622, 10.1002/ana.410200511 https://www.cdc.gov/nchs/data/databriefs/db328_tables-508.pdf#3. http://www.indepth-network.org/Resource%20Kit/INDEPTH%20DSS%20Resource%20Kit/LinkedDocuments/INDEPTH%20Monograph%20I%20Ch1-7%20Introduction,%20Methods%20&%20Life%20Tables.pdf. Klein, 2010, Rates of autoimmune diseases in Kaiser Permanente for use in vaccine adverse event safety studies, Vaccine, 28, 1062, 10.1016/j.vaccine.2009.10.115 Jeffery, 1993, Transverse myelitis. Retrospective analysis of 33 cases, with diff erentiation of casesassociated with multiple sclerosis and parainfectious events, Arch Neurol, 50, 532, 10.1001/archneur.1993.00540050074019 Beghi, 1985, Guillain-Barré syndrome. Clinicoepidemiologic features and effect of influenza vaccine, Arch Neurol., 42, 1053, 10.1001/archneur.1985.04060100035016 Huang, 2015, A 15 year nationwde epidemiological analysis of Guillain-Barré Syndrome in Taiwan, Neuroepidemology, 44 Williams C, Dodd C, Sturkenboom M. et al. Incidence rates of autoimmune diseases in european healthcare databases: A contribution of the ADVANCE Project. Drug Safety online January 19, 2021. https://doi.org/10.1007/s40264-020-01031-1. Alonso, 2007, Incidence of multiple sclerosis in the United Kingdom, J Neurol, 254, 1736, 10.1007/s00415-007-0602-z