COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals

K Faksova; D Walsh; Y Jiang; J Griffin; A Phillips; A Gentile; J C Kwong; K Macartney; M Naus; Z Grange; S Escolano; G Sepulveda; A Shetty; A Pillsbury; C Sullivan; Z Naveed; N Z Janjua; N Giglio; J Perälä; S Nasreen; H Gidding; P Hovi; T Vo; F Cui; L Deng; L Cullen; M Artama; H Lu; H J Clothier; K Batty; J Paynter; H Petousis-Harris; J Buttery; S Black; A Hviid

doi:10.1016/j.vaccine.2024.01.100

COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) cohort study of 99 million vaccinated individuals

Vaccine. 2024 Apr 2;42(9):2200-2211. doi: 10.1016/j.vaccine.2024.01.100. Epub 2024 Feb 12.

Authors

K Faksova¹, D Walsh², Y Jiang², J Griffin³, A Phillips⁴, A Gentile⁵, J C Kwong⁶, K Macartney⁷, M Naus⁸, Z Grange⁹, S Escolano¹⁰, G Sepulveda¹¹, A Shetty¹¹, A Pillsbury⁴, C Sullivan⁹, Z Naveed⁸, N Z Janjua⁸, N Giglio⁵, J Perälä¹², S Nasreen¹³, H Gidding⁷, P Hovi¹⁴, T Vo¹⁵, F Cui¹⁶, L Deng⁴, L Cullen⁹, M Artama¹⁵, H Lu², H J Clothier¹⁷, K Batty¹⁸, J Paynter¹⁹, H Petousis-Harris²⁰, J Buttery²¹, S Black²⁰, A Hviid²²

Affiliations

¹ Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark. Electronic address: kfak@ssi.dk.
² Department of Statistics, University of Auckland, New Zealand; Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand.
³ Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand.
⁴ National Centre for Immunisation Research and Surveillance, Westmead, New South Wales, Australia.
⁵ Department of Epidemiology, Ricardo Gutierrez Children Hospital, Buenos Aires University, Argentina.
⁶ 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.
⁷ National Centre for Immunisation Research and Surveillance, Westmead, New South Wales, Australia; The University of Sydney, Australia.
⁸ British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada; School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.
⁹ Public Health Scotland, Glasgow, Scotland, United Kingdom.
¹⁰ Université Paris-Saclay, UVSQ, Inserm, CESP, High Dimensional Biostatistics for Drug Safety and Genomics, Villejuif, France.
¹¹ Murdoch Children's Research Institute, Parkville, Victoria, Australia.
¹² Department of Health Security, Finnish Institute for Health and Welfare, Helsinki, Finland.
¹³ ICES, Toronto, Ontario, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada; School of Public Health, SUNY Downstate Health Sciences University, Brooklyn, NY, USA.
¹⁴ Department of Public Welfare, Finnish Institute for Health and Welfare, Helsinki, Finland.
¹⁵ Faculty of Social Sciences, Tampere University, Finland.
¹⁶ School of Public Health, Peking University, China.
¹⁷ Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand; Murdoch Children's Research Institute, Parkville, Victoria, Australia.
¹⁸ Auckland UniServices Limited at University of Auckland, New Zealand.
¹⁹ School of Population Health, University of Auckland, New Zealand.
²⁰ Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand; School of Population Health, University of Auckland, New Zealand.
²¹ Global Vaccine Data Network, Global Coordinating Centre, Auckland, New Zealand; Murdoch Children's Research Institute, Parkville, Victoria, Australia; University of Melbourne, Parkville, Victoria, Australia.
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: 38350768
DOI: 10.1016/j.vaccine.2024.01.100

Abstract

Background: The Global COVID Vaccine Safety (GCoVS) Project, established in 2021 under the multinational Global Vaccine Data Network™ (GVDN®), facilitates comprehensive assessment of vaccine safety. This study aimed to evaluate the risk of adverse events of special interest (AESI) following COVID-19 vaccination from 10 sites across eight countries.

Methods: Using a common protocol, this observational cohort study compared observed with expected rates of 13 selected AESI across neurological, haematological, and cardiac outcomes. Expected rates were obtained by participating sites using pre-COVID-19 vaccination healthcare data stratified by age and sex. Observed rates were reported from the same healthcare datasets since COVID-19 vaccination program rollout. AESI occurring up to 42 days following vaccination with mRNA (BNT162b2 and mRNA-1273) and adenovirus-vector (ChAdOx1) vaccines were included in the primary analysis. Risks were assessed using observed versus expected (OE) ratios with 95 % confidence intervals. Prioritised potential safety signals were those with lower bound of the 95 % confidence interval (LBCI) greater than 1.5.

Results: Participants included 99,068,901 vaccinated individuals. In total, 183,559,462 doses of BNT162b2, 36,178,442 doses of mRNA-1273, and 23,093,399 doses of ChAdOx1 were administered across participating sites in the study period. Risk periods following homologous vaccination schedules contributed 23,168,335 person-years of follow-up. OE ratios with LBCI > 1.5 were observed for Guillain-Barré syndrome (2.49, 95 % CI: 2.15, 2.87) and cerebral venous sinus thrombosis (3.23, 95 % CI: 2.51, 4.09) following the first dose of ChAdOx1 vaccine. Acute disseminated encephalomyelitis showed an OE ratio of 3.78 (95 % CI: 1.52, 7.78) following the first dose of mRNA-1273 vaccine. The OE ratios for myocarditis and pericarditis following BNT162b2, mRNA-1273, and ChAdOx1 were significantly increased with LBCIs > 1.5.

Conclusion: This multi-country analysis confirmed pre-established safety signals for myocarditis, pericarditis, Guillain-Barré syndrome, and cerebral venous sinus thrombosis. Other potential safety signals that require further investigation were identified.

Keywords: Adverse events following immunization; Adverse events of special interest; COVID-19; Observed vs. expected analysis; Pharmacovigilance; Vaccine safety surveillance.

Publication types

Observational Study

MeSH terms

2019-nCoV Vaccine mRNA-1273
BNT162 Vaccine
COVID-19 Vaccines / adverse effects
COVID-19* / prevention & control
Cohort Studies
Female
Guillain-Barre Syndrome* / chemically induced
Guillain-Barre Syndrome* / epidemiology
Humans
Male
Myocarditis*
Pericarditis*
Sinus Thrombosis, Intracranial*
Vaccination / adverse effects
mRNA Vaccines

Substances

2019-nCoV Vaccine mRNA-1273
BNT162 Vaccine
COVID-19 Vaccines
mRNA Vaccines