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

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  • 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
  • E. Weintraub
  • H. Lu
  • H. J. Clothier
  • K. Batty
  • J. Paynter
  • H. Petousis-Harris
  • J. Buttery
  • S. Black

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.

Original languageEnglish
JournalVaccine
Volume42
Issue number9
Pages (from-to)2200-2211
ISSN0264-410X
DOIs
Publication statusPublished - 2024

Bibliographical note

Publisher Copyright:
© 2024 The Author(s)

    Research areas

  • Adverse events following immunization, Adverse events of special interest, COVID-19, Observed vs. expected analysis, Pharmacovigilance, Vaccine safety surveillance

ID: 387024339