Background rates of adverse events of special interest for COVID-19 vaccines: A multinational Global Vaccine Data Network (GVDN) analysis

A Phillips; Y Jiang; D Walsh; N Andrews; M Artama; H Clothier; L Cullen; L Deng; S Escolano; A Gentile; G Gidding; N Giglio; T Junker; W Huang; N Janjua; J Kwong; J Li; S Nasreen; M Naus; Z Naveed; A Pillsbury; J Stowe; T Vo; J Buttery; H Petousis-Harris; S Black; A Hviid

doi:10.1016/j.vaccine.2023.08.079

Background rates of adverse events of special interest for COVID-19 vaccines: A multinational Global Vaccine Data Network (GVDN) analysis

Vaccine. 2023 Oct 6;41(42):6227-6238. doi: 10.1016/j.vaccine.2023.08.079. Epub 2023 Sep 5.

Authors

A Phillips¹, Y Jiang², D Walsh², N Andrews³, M Artama⁴, H Clothier⁵, L Cullen⁶, L Deng¹, S Escolano⁷, A Gentile⁸, G Gidding⁹, N Giglio⁸, T Junker¹⁰, W Huang¹¹, N Janjua¹², J Kwong¹³, J Li¹⁴, S Nasreen¹⁵, M Naus¹⁶, Z Naveed¹⁷, A Pillsbury¹, J Stowe³, T Vo¹⁸, J Buttery¹⁹, H Petousis-Harris²⁰, S Black²¹, A Hviid²²

Affiliations

¹ National Centre for Immunisation Research and Surveillance, Westmead, New South Wales, Australia.
² Department of Statistics, University of Auckland, New Zealand; Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand.
³ UK Health Security Agency, London, UK.
⁴ Faculty of Social Sciences, Tampere University, Finland.
⁵ Murdoch Children's Research Institute, Parkville, Victoria, Australia.
⁶ Public Health Scotland, Edinburgh, Scotland, UK.
⁷ Université Paris-Saclay, UVSQ, Inserm, CESP, High Dimensional Biostatistics for Drug Safety and Genomics, Villejuif, France.
⁸ Hospital de Niños Ricardo Gutierrez Epidemiology Department Buenos Aires City, Argentina.
⁹ National Centre for Immunisation Research and Surveillance, Westmead, New South Wales, Australia; The University of Sydney Northern Clinical School, Australia.
¹⁰ Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark.
¹¹ Global Health Program, College of Public Health, National Taiwan University, Taipei, Taiwan; National Taiwan University Children's Hospital, Taipei, Taiwan.
¹² British Columbia Centre for Disease Control, Vancouver, Canada; School of Population and Public Health, University of British Columbia, Vancouver, Canada; Centre for Health Evaluation and Outcome Sciences, St Paul's Hospital, Vancouver, Canada.
¹³ ICES, Toronto, Ontario, Canada; Public Health Ontario, Toronto, Ontario, Canada; Department of Family and Community Medicine, Temerty Faculty of Medicine and the Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
¹⁴ British Columbia Centre for Disease Control, Vancouver, Canada.
¹⁵ ICES, Toronto, Ontario, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
¹⁶ British Columbia Centre for Disease Control, Vancouver, Canada; School of Population and Public Health, University of British Columbia, Vancouver, Canada.
¹⁷ School of Population and Public Health, University of British Columbia, Vancouver, Canada.
¹⁸ Faculty of Social Sciences, Tampere University, Finland; Department of Health Security, Finnish Institute for Health and Welfare, Helsinki, Finland.
¹⁹ Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand; Murdoch Children's Research Institute, Parkville, Victoria, Australia.
²⁰ Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand; Associate Professor, School of Population Health, University of Auckland, New Zealand.
²¹ Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand.
²² Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark; Pharmacovigilance Research Center, Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.

PMID: 37673715
DOI: 10.1016/j.vaccine.2023.08.079

Abstract

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.

Keywords: Adverse event following immunization; Background rates; COVID-19; Pharmacovigilance; Vaccine safety surveillance.

Publication types

Research Support, U.S. Gov't, P.H.S.

MeSH terms

COVID-19 Vaccines* / adverse effects
COVID-19* / epidemiology
COVID-19* / prevention & control
Humans
Incidence
Vaccination
Vaccines / adverse effects

Substances

COVID-19 Vaccines
Vaccines