COVID-19 vaccination was a rare potential etiology for cause of death after medicolegal autopsy. A Finnish nationwide study.

medrxiv(2024)

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摘要
COVID-19 vaccinations began globally at the end of 2020. By the end of 2021, 9.8 million doses were given in Finland. Regarding safety, most vaccine-related adverse reactions have been mild, but serious and lethal ones have also occurred. Autopsies in post vaccination deaths may give insight to the extent of fatal health conditions with potential COVID-19 vaccine etiology and provide new hypotheses of possible causalities between vaccination and severe health conditions. We searched the complete documentation on all medicolegal autopsies in Finland between December 2020 and December 2021 to assess how often the basis for autopsy was a suspected fatal adverse reaction to COVID-19 vaccination, and whether vaccination remained a potential etiology for any health condition determined as a cause of death after the autopsy. We linked register-based data on individual COVID-19 vaccination course and pre-existing health conditions. We found 428 autopsy cases with a mention of COVID-19 vaccination, and prior to autopsy, vaccination was suspected to play a part in 76 deaths. Post autopsy, a forensic pathologist considered vaccination as a potential etiology in five underlying and seven contributory causes of death. These included seven thromboembolisms, two diabetic ketoacidoses, one myocarditis, one acute pancreatitis, and one eosinophilic granulomatosis with polyangiitis. In relation to the number of vaccinations within Finland, a suspicion of vaccine-related serious adverse reaction was rarely an indication for medicolegal autopsy. Even less frequently was vaccination considered to play a part in the process leading to death, although considerable doubt remains in the accuracy of individual considerations, and autopsy cannot definitively confirm causality between vaccination and death. Regarding vaccination safety, continuing evaluation of suspected vaccine-related deaths is essential, and an autopsy should be part of the investigation when such a suspicion arises. ### Competing Interest Statement L.P. is a former small shareholder of AstraZeneca. H.N. is a member of the National Immunization Technical Advisory Group of Finnish Institute for Health and Welfare (THL). H.N. is chair of the WHO Strategic Advisory Group of Experts. THL has until 9/2022 conducted Public-Private Partnerships with vaccine manufacturers and has previously received research funding for studies unrelated to COVID-19 from GlaxoSmithKline Vaccines, Pfizer, and Sanofi Pasteur (including T.N. as an investigator). All other authors declare no financial or non-financial competing interests. ### Funding Statement This study received no specific funding. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This descriptive study was conducted as part of the Finnish Institute for Health and Welfare's responsibility to monitor the safety of vaccines used in the national vaccination program and to investigate potential adverse events suspected to be linked with vaccination as dictated by the Finnish law (Act on the National Institute for Health and Welfare 668/2008; Government Decree on the National Institute for Health and Welfare 675/2008; and the Communicable Diseases Act 1227/2016). Based on this, Finnish Institute for Health and Welfare has the statutory right, notwithstanding confidentiality provisions, to access necessary information in cause-of-death investigation documents and to link this information with other relevant register data. Accordingly, this study was approved by the Finnish Institute for Health and Welfare's Director of Health Security department, Director of Government Services department, as well as the Deputy Director General of Research, Development and Innovation. The data on the medicolegal autopsies was originally collected according to the Act on Determining the Cause of Death (459/1973). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data generated or analyzed during this study are included in this published article.
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