TY - JOUR
T1 - Background rates of adverse events of special interest for COVID-19 vaccines
T2 - A multinational Global Vaccine Data Network (GVDN) analysis
AU - Phillips, A.
AU - Jiang, Y.
AU - Walsh, D.
AU - Andrews, N.
AU - Artama, M.
AU - Clothier, H.
AU - Cullen, L.
AU - Deng, L.
AU - Escolano, S.
AU - Gentile, A.
AU - Gidding, G.
AU - Giglio, N.
AU - Junker, T.
AU - Huang, W.
AU - Janjua, N.
AU - Kwong, J.
AU - Li, J.
AU - Nasreen, S.
AU - Naus, M.
AU - Naveed, Z.
AU - Pillsbury, A.
AU - Stowe, J.
AU - Vo, T.
AU - Buttery, J.
AU - Petousis-Harris, H.
AU - Black, S.
AU - Hviid, A.
N1 - Funding Information:
The Background Rates of Adverse Events of Special Interest Following COVID-19 Vaccination Study Protocol was developed by the Background Rates and Observed vs. Expected Work Group led by Anders Hviida,b. Members of the Work Group were Nelson Aguirre Duartec, Karin Battyd, Steven Blackc,e, Hannah Chisholmc, Hazel Clothierf,g,h, Heather Giddingi,j,k, Petteri Hovil, Yannan Jiangc, Janine Paynterc, Helen Petousis-Harrisc, Anastasia Phillipsi, John Sluyterc, Thuan Vol,m, and Daniel Walshc. Work group affiliations. a. Statens Serum Institut, Denmark; b. University of Copenhagen, Denmark; c. University of Auckland, New Zealand; d. Auckland UniServices Limited at University of Auckland, New Zealand; e. University of Cincinnati and Children's Hospital, USA; f. Victorian Department of Health, Australia; g. SAFEVIC, Murdoch Childrens Research Institute, Australia; h. Centre for Health Analytics, Melbourne Children's Campus, Australia; i. National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, Australia; j. Kolling Institute, Northern Sydney Local Health District, Australia; k. University of Sydney Northern Clinical School, Australia; l. Finnish Institute for Health and Welfare, Finland; m. Tampere University, Finland. The following individuals contributed as GVDN site investigators: Nicolas Falk (statistical analysis) and Mariana Cohelo (data collection) (Argentina); Aishwarya Shetty (Australia - Victoria); Andrew Calzavara (Canada-Ontario); Petteri Hovi, Hanna Nohynek, Tuomo Nieminen (Finnish Institute for Health and Welfare); K. Arnold Chan, Ting-Chuan Wang, and Ya-Ling Huang (National Taiwan University) (data collection) and the Health and Welfare Data Science Center (HWDC), Ministry of Health and Welfare (data coordination) (Taiwan).
Funding Information:
The GCoVS is supported by the Centers for Disease Control and Prevention (CDC) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award totalling US$10,108,491 with 100% funded by CDC/HHS.
Funding Information:
The Ontario site contributing to this study was supported by Public Health Ontario and by the Institute for Clinical Evaluative Sciences, which is funded by an annual grant from the Ontario Ministry of Health. JCK is supported by a Clinician-Scientist Award from the University of Toronto Department of Family and Community Medicine.
Publisher Copyright:
© 2023
PY - 2023/10/6
Y1 - 2023/10/6
N2 - Background: The Global COVID Vaccine Safety (GCoVS) project was established in 2021 under the multinational Global Vaccine Data Network (GVDN) consortium to facilitate the rapid assessment of the safety of newly introduced vaccines. This study analyzed data from GVDN member sites on the background incidence rates of conditions designated as adverse events of special interest (AESI) for COVID-19 vaccine safety monitoring. Methods: Eleven GVDN global sites obtained data from national or regional healthcare databases using standardized methods. Incident events of 13 pre-defined AESI were included for a pre-pandemic period (2015–19) and the first pandemic year (2020). Background incidence rates (IR) and 95% confidence intervals (CI) were calculated for inpatient and emergency department encounters, stratified by age and sex, and compared between pre-pandemic and pandemic periods using incidence rate ratios. Results: An estimated 197 million people contributed 1,189,652,926 person-years of follow-up time. Among inpatients in the pre-pandemic period (2015–19), generalized seizures were the most common neurological AESI (IR ranged from 22.15 [95% CI 19.01–25.65] to 278.82 [278.20–279.44] per 100,000 person-years); acute disseminated encephalomyelitis was the least common (<0.5 per 100,000 person-years at most sites). Pulmonary embolism was the most common thrombotic event (IR 45.34 [95% CI 44.85–45.84] to 93.77 [95% CI 93.46–94.08] per 100,000 person-years). The IR of myocarditis ranged from 1.60 [(95% CI 1.45–1.76) to 7.76 (95% CI 7.46–8.08) per 100,000 person-years. The IR of several AESI varied by site, healthcare setting, age and sex. The IR of some AESI were notably different in 2020 compared to 2015–19. Conclusion: Background incidence of AESIs exhibited some variability across study sites and between pre-pandemic and pandemic periods. These findings will contribute to global vaccine safety surveillance and research.
AB - Background: The Global COVID Vaccine Safety (GCoVS) project was established in 2021 under the multinational Global Vaccine Data Network (GVDN) consortium to facilitate the rapid assessment of the safety of newly introduced vaccines. This study analyzed data from GVDN member sites on the background incidence rates of conditions designated as adverse events of special interest (AESI) for COVID-19 vaccine safety monitoring. Methods: Eleven GVDN global sites obtained data from national or regional healthcare databases using standardized methods. Incident events of 13 pre-defined AESI were included for a pre-pandemic period (2015–19) and the first pandemic year (2020). Background incidence rates (IR) and 95% confidence intervals (CI) were calculated for inpatient and emergency department encounters, stratified by age and sex, and compared between pre-pandemic and pandemic periods using incidence rate ratios. Results: An estimated 197 million people contributed 1,189,652,926 person-years of follow-up time. Among inpatients in the pre-pandemic period (2015–19), generalized seizures were the most common neurological AESI (IR ranged from 22.15 [95% CI 19.01–25.65] to 278.82 [278.20–279.44] per 100,000 person-years); acute disseminated encephalomyelitis was the least common (<0.5 per 100,000 person-years at most sites). Pulmonary embolism was the most common thrombotic event (IR 45.34 [95% CI 44.85–45.84] to 93.77 [95% CI 93.46–94.08] per 100,000 person-years). The IR of myocarditis ranged from 1.60 [(95% CI 1.45–1.76) to 7.76 (95% CI 7.46–8.08) per 100,000 person-years. The IR of several AESI varied by site, healthcare setting, age and sex. The IR of some AESI were notably different in 2020 compared to 2015–19. Conclusion: Background incidence of AESIs exhibited some variability across study sites and between pre-pandemic and pandemic periods. These findings will contribute to global vaccine safety surveillance and research.
KW - Adverse event following immunization
KW - Background rates
KW - COVID-19
KW - Pharmacovigilance
KW - Vaccine safety surveillance
UR - http://www.scopus.com/inward/record.url?scp=85170415673&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2023.08.079
DO - 10.1016/j.vaccine.2023.08.079
M3 - Article
C2 - 37673715
AN - SCOPUS:85170415673
SN - 0264-410X
VL - 41
SP - 6227
EP - 6238
JO - Vaccine
JF - Vaccine
IS - 42
ER -
