Using the Bradford-Hill criteria to assess causality in the association between CHADOX1 NCOV-19 vaccine and thrombotic immune thrombocytopenia

Authors

DOI:

https://doi.org/10.31646/gbio.109

Keywords:

Thrombosis, VITT, HITT, heparin, COVID-19, vaccine, Astrazeneca, CHADOX1 NCOV vaccine, thrombocytopenia

Abstract

The Bradford-Hill criteria are accepted criteria for assessing causality of an association. Here, the criteria were applied to the association between the CHADOX1 NCOV-19 vaccine and vaccine induced thrombotic immune thrombocytopenia (VITT). All criteria for causation are met, with consistency, specificity, temporality and biological plausibility being very clearly met. Strength of association is met, but more data are required to establish the precise estimate of the association, as case ascertainment may be variable between countries, resulting in varied estimates of incidence rates from 25 to 0.5 per 100,000. (2, 4) The application of the modified Bradford-Hill criteria to VITT following CHADOX1 NCOV- vaccine strongly supports a causal relationship.

Author Biography

C Raina MacIntyre, University of New South Wales

Professor Raina MacIntyre (MBBS Hons 1, M App Epid, PhD, FRACP, FAFPHM) is Professor of Global Biosecurity at the Kirby Institute, UNSW Sydney. She is a dual-specialist physician with extensive track record in infectious diseases, vaccines and transmission dynamics of pathogens. As Head of the Biosecurity Program, she leads research in epidemiology, vaccinology, bioterrorism prevention, mathematical modelling, public health and clinical trials in infectious diseases. Her research includes personal protective equipment, vaccinology, epidemics of emerging infectious diseases and bioterrorism prevention. She is an expert in influenza epidemiology, adult vaccination, bioterrorism and rapid epidemic intelligence and has led the largest body of research internationally on face masks and respirators in health care workers. She has a 20 year track record in public health control of infectious diseases including vaccinology, surveillance and program design. She has over 370 publications in peer-reviewed journals. Her research is underpinned by extensive field outbreak investigation experience. She is a graduate of the Australian Field Epidemiology Training program and has extensive experience in shoe-leather epidemiology of infectious diseases outbreaks. Her in-depth understanding of the science of outbreak investigation draws from this experience combined with her clinical training as a specialist physician and her academic training through a Masters and PhD in Epidemiology. Her passion for field epidemiology led her to co-found the ARM network for Australian field outbreak response. She also has an interest in the ethics of medicine, and specifically in dual-use research of concern in the fields of synthetic biology and genetic engineering, and the risk this poses to biosecurity. She is on editorial boards for Vaccine, BMJ Open and Epidemiology & Infection, and has served on numerous expert committees including for WHO, IOM and OIE. She was won numerous awards for her research including the Sir Henry Wellcome Medal from the Association of Military Surgeons of the United States, the National Immunisation Award from Public Health Association of Australia, and the Frank Fenner Prize for advanced research in infectious diseases. See: https://research.unsw.edu.au/people/professor-raina-macintyre

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Published

2021-04-13

How to Cite

MacIntyre, C. R. (2021). Using the Bradford-Hill criteria to assess causality in the association between CHADOX1 NCOV-19 vaccine and thrombotic immune thrombocytopenia. Global Biosecurity, 3(1). https://doi.org/10.31646/gbio.109

Issue

Vol. 3 (2021)

Section

Rapid Reports and Perspectives From the Field

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Received 2021-04-10
Accepted 2021-04-10
Published 2021-04-13