Risk of venous thromboembolism after SARS‐CoV‐2 vaccination—Evidence from genome‐wide association study and population‐based observational study
Year: 2026
Type: article
Study design: Observational Study
Abstract: AIM: We aimed to investigate whether genetic variation is associated with venous thromboembolism after immunization with SARS-CoV-2 vaccines. METHODS: We conducted a genome-wide association study (GWAS) on cases of venous thromboembolism within 42 days after SARS-CoV-2 vaccination, recruited from reports of adverse drug reactions sent to the Swedish Medical Products Agency. Two hundred one cases (43% women, 91% Swedish) were compared with 4891 Swedish population controls. Analyses were performed on two candidate variants in coagulation factor II (rs1799963) and coagulation factor V (rs6025), on 14 prespecified candidate genes and across the whole genome. To support the findings, we conducted an observational register study of the Swedish general population with/without a diagnosis of thrombophilia and the risks of venous thromboembolism after SARS-CoV-2 vaccination. RESULTS: In the GWAS, the main findings were that the candidate variants of coagulation factors II rs1799963 and V rs6025 were significantly associated with venous thromboembolism (odds ratio [OR] 2.4 [95% confidence interval (CI) 1.2-4.8], p = .015 and OR 1.8 [95% CI 1.3-2.6], p = .0022). No genetic marker passed the significance threshold in the candidate gene analysis or the full genome-wide analysis. In the register study, people with a thrombophilia diagnosis had a five-fold elevated risk of venous thromboembolism within 42 days after vaccination, adjusted for potential confounders, OR 5.06 [95% CI 3.98-6.44]. CONCLUSION: Well-characterized genetic variants in the genes of coagulation factors II and V were associated with thromboembolism after SARS-CoV-2 immunization. Further research is recommended to elucidate their potential role in vaccine-related thromboembolic events.
DOI: 10.1002/bcp.70614
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,780
Funders: Svenska Forskningsrådet Formas, Hjärt-Lungfonden, Karolinska Institutet, Knut och Alice Wallenbergs Stiftelse, Vetenskapsrådet, Norges Forskningsråd, Akademiska Sjukhuset, Forskningsrådet om Hälsa, Arbetsliv och Välfärd, Uppsala Universitet, STROKE-Riksförbundet, Science for Life Laboratory, Terveyden Tutkimuksen Toimikunta, Uppsala Multidisciplinary Center for Advanced Computational Science
Awards: G1379748034, G1794528886, G1810861923, Real-life vaccine surveillance, immunological effect studies and infrastructure development for pandemic preparedness on a national level (RE-VISION), G203835366, G335592866, Strategic initiative in pharmacogenetics: from discovery to implementation, SCIFI-PEARL - a national register project for research about COVID-19, health crises and pharmacoepidemiology, G4066480865, G4211878931, G4484478735, G4923227014, Demographics and other characteristics, comorbidities and risk factors for Covid-19 onset and prognosis, G5552896489, G6424141678, The epidemiology, immunology and genetics of adverse reactions to COVID-19 vaccines, G6973710499, Innovative tools in precision medicine to understand and predict immune-mediated and haematological adverse drug reactions, G712881263, G7142172845, G7196822436, G741160422, G8208805722, G8209820628, G8365145670, The Swedish Twin Registry, G8606143875, G8714740109, G8736225608, G885211927, Protocols of Killings: 1965, distance, and the ethics of future warfare
OpenAlex ID: W7162687015