EHDEN Data Partners from nine countries and others recently came together to collaborate on a large-scale study on the counterfactual effects of SARS-CoV-2 infection in unvaccinated subjects.
"This is the largest COVID-19 study I know of, including almost 24m people with COVID and over 945m 'general population' participants from twenty-six data sources across three continents".
The findings suggest that COVID-19 leads to a higher-than-expected risk of all fifteen pre-specified adverse events of special interest (AESI) monitored as potential side effects of COVID vaccines, including: GBS, facial nerve (Bell's) palsy, anaphylaxis, encephalomyelitis, narcolepsy, appendicitis, non-haemorrhagic stroke, haemorrhagic stroke, acute myocardial infarction, myocarditis and pericarditis, deep vein thrombosis, pulmonary embolism, disseminated intravascular coagulation, immune thrombocytopenia, transverse myelitis, and the cooccurrence of thrombosis with thrombocytopenia.
The increase in observed vs expected risk varied greatly, and was highest for pulmonary embolism (almost 12-fold), disseminated intravascular coagulation (almost 9), and myocarditis/pericarditis (almost 8).
This work was led by Erica Voss, MPH, PMP and shows the power of federated analytics using the OMOP Common Data Model in collaboration with EHDEN Data Partners from Belgium, Estonia, France, Germany, Netherlands, Serbia, Spain, Turkey, and the UK and others.
All results were published in The Lancet’s eClinical Medicine Journal.