Detailed review of mortality reported following COVID-19 vaccination in Victoria, Australia: 2021-2023

Ingrid Laemmle-Ruff; Jesse J Fryk; Priya Shenton; Hazel J Clothier; Sarah Parsons; Linda Iles; Clare White; Michael Murray; Jim Buttery; Nigel W Crawford

doi:10.1016/j.vaccine.2024.126368

Detailed review of mortality reported following COVID-19 vaccination in Victoria, Australia: 2021-2023

Vaccine. 2024 Sep 20;42(26):126368. doi: 10.1016/j.vaccine.2024.126368. Online ahead of print.

Authors

Affiliations

¹ Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC), Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of General Medicine, Royal Children's Hospital, Melbourne, Victoria, Australia. Electronic address: [email protected].
² Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC), Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Centre for Health Analytics, Royal Children's Hospital, Melbourne, Victoria, Australia.
³ Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC), Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of General Medicine, Royal Children's Hospital, Melbourne, Victoria, Australia.
⁴ Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC), Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Centre for Health Analytics, Royal Children's Hospital, Melbourne, Victoria, Australia; Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia; School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.
⁵ Victorian Institute of Forensic Medicine, Melbourne, Victoria, Australia; Department of Forensic Medicine, Monash University, Victoria, Australia.
⁶ Victorian Institute of Forensic Medicine, Melbourne, Victoria, Australia.
⁷ Department of Geriatric Medicine, Western Health, Melbourne, Victoria, Australia.
⁸ Department of Geriatric Medicine, Austin Health, Melbourne, Victoria, Australia.
⁹ Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC), Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Centre for Health Analytics, Royal Children's Hospital, Melbourne, Victoria, Australia; Department of General Medicine, Royal Children's Hospital, Melbourne, Victoria, Australia; Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia.
¹⁰ Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC), Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of General Medicine, Royal Children's Hospital, Melbourne, Victoria, Australia; Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia.

PMID: 39305837
DOI: 10.1016/j.vaccine.2024.126368

Abstract

Introduction: The scale of the COVID-19 vaccine program, and appropriate focus on older individuals, emphasised monitoring of mortality as an important part of COVID-19 vaccine safety surveillance, noting many deaths temporally associated with vaccination may not be causally related. This cross-sectional study describes Victoria's vaccine safety service (SAEFVIC) process of reviewing mortality reports following COVID-19 vaccination, summarises report characteristics and identifies trends in mortality reporting.

Methods: Mortality cases reported to SAEFVIC following COVID-19 vaccination from 22 February 2021 to 22 February 2023 were included. Report characteristics, demographics, and cause of death information were described. Proportions of mortality reports per 100,000 vaccine doses administered were calculated, overall and stratified by age (<60 years, ≥60 years), sex, vaccine type and dose number. Rate ratios (RR) were used to compare proportions.

Results: Reporting proportions were higher in the first three months of the vaccine program (3.98 per 100,000 doses), compared to the following 21 months (0.71 per 100,000 doses), RR:5.61, p < 0.001. Of 159 mortality reports included, 135/159 (84.9 %) were in individuals ≥60 years. Most individuals (121/159, 90.3 %) had comorbidities relevant to cause(s) of death, and 143/159 (89.9 %) were categorised as having a 'likely alternate' cause of death based on treating clinician/forensic assessment. For 11/159 (6.9 %) reports vaccine contribution to death could not be determined. Five deaths (0.03 per 100,000 doses administered), all publicly reported, were assessed by the national regulator as likely vaccine-associated.

Conclusions: Mortality reporting predominantly reflected the health status of the population receiving vaccines, vaccine administration patterns and contextual factors surrounding COVID-19 vaccines (including public concerns regarding serious adverse events of special interest), as well as extremely rare but fatal adverse events that were likely vaccine-associated. Jurisdictional vaccine safety services such as SAEFVIC play an important role in follow-up of mortality reports, supporting the work of national regulators, and thereby supporting vaccine safety surveillance and vaccine confidence more broadly.

Keywords: COVID-19; Death; Immunisation; Mortality; Pharmacovigilance; SARS-CoV-2; Safety; Vaccine.