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dc.contributor.authorKerr, Steven
dc.contributor.authorJoy, Mark
dc.contributor.authorTorabi, Fatemeh
dc.contributor.authorBedston, Stuart
dc.contributor.authorAkbari, Ashley
dc.contributor.authorAgrawal, Utkarsh
dc.contributor.authorBeggs, Jillian
dc.contributor.authorBradley, Declan
dc.contributor.authorChuter, Antony
dc.contributor.authorDocherty, Annemarie B.
dc.contributor.authorFord, David
dc.contributor.authorHobbs, Richard
dc.contributor.authorKatikireddi, Srinivasa Vittal
dc.contributor.authorLowthian, Emily
dc.contributor.authorde Lusignan, Simon
dc.contributor.authorLyons, Ronan
dc.contributor.authorMarple, James
dc.contributor.authorMcCowan, Colin
dc.contributor.authorMcGagh, Dylan
dc.contributor.authorMcMenamin, Jim
dc.contributor.authorMoore, Emily
dc.contributor.authorMurray, Josephine-L. K.
dc.contributor.authorOwen, Rhiannon K.
dc.contributor.authorPan, Jiafeng
dc.contributor.authorRitchie, Lewis
dc.contributor.authorShah, Syed Ahmar
dc.contributor.authorShi, Ting
dc.contributor.authorStock, Sarah
dc.contributor.authorTsang, Ruby S. M.
dc.contributor.authorVasileiou, Eleftheria
dc.contributor.authorWoolhouse, Mark
dc.contributor.authorSimpson, Colin R.
dc.contributor.authorRobertson, Chris
dc.contributor.authorSheikh, Aziz
dc.contributor.editorCannegieter, Suzanne C.
dc.date.accessioned2022-02-24T16:30:12Z
dc.date.available2022-02-24T16:30:12Z
dc.date.issued2022-02-22
dc.identifier278038545
dc.identifier6f5fa076-8cc8-4053-9058-afa375c519c8
dc.identifier000761036700002
dc.identifier85125154473
dc.identifier.citationKerr , S , Joy , M , Torabi , F , Bedston , S , Akbari , A , Agrawal , U , Beggs , J , Bradley , D , Chuter , A , Docherty , A B , Ford , D , Hobbs , R , Katikireddi , S V , Lowthian , E , de Lusignan , S , Lyons , R , Marple , J , McCowan , C , McGagh , D , McMenamin , J , Moore , E , Murray , J-L K , Owen , R K , Pan , J , Ritchie , L , Shah , S A , Shi , T , Stock , S , Tsang , R S M , Vasileiou , E , Woolhouse , M , Simpson , C R , Robertson , C , Sheikh , A & Cannegieter , S C (ed.) 2022 , ' First dose ChAdOx1 and BNT162b2 COVID-19 vaccinations and cerebral venous sinus thrombosis : a pooled self-controlled case series study of 11.6 million individuals in England, Scotland, and Wales ' , PLoS Medicine , vol. 19 , no. 2 , e1003927 . https://doi.org/10.1371/journal.pmed.1003927en
dc.identifier.issn1549-1277
dc.identifier.otherJisc: 109048
dc.identifier.otherpublisher-id: pmedicine-d-21-03598
dc.identifier.otherORCID: /0000-0002-9466-833X/work/108918705
dc.identifier.otherORCID: /0000-0002-1511-7944/work/115941589
dc.identifier.urihttps://hdl.handle.net/10023/24953
dc.descriptionFunding: This research is part of the Data and Connectivity National Core Study, led by Health Data Research UK in partnership with the Office for National Statistics and funded by UK Research and Innovation (grant ref MC_PC_20029, AS). EAVE II is funded by the Medical Research Council (https://mrc.ukri.org/) (UKRI MC_PC 19075, AS) with the support of BREATHE, The Health Data Research Hub for Respiratory Health (MC_PC_19004, AS), which is funded through the UK Research and Innovation Industrial Strategy Challenge Fund and delivered through Health Data Research UK. This work was supported by the Con-COV team funded by the Medical Research Council (grant number: MR/V028367/1, RL). This work was supported by Health Data Research UK, which receives its funding from HDR UK Ltd (HDR-9006, RL) funded by the UK Medical Research Council, Engineering and Physical Sciences Research Council, Economic and Social Research Council, Department of Health and Social Care (England), Chief Scientist Office of the Scottish Government Health and Social Care Directorates, Health and Social Care Research and Development Division (Welsh Government), Public Health Agency (Northern Ireland), British Heart Foundation (BHF) and the Wellcome Trust. This work was supported by the ADR Wales programme of work (https://www.adruk.org/). ADR Wales is part of the Economic and Social Research Council (part of UK Research and Innovation) funded ADR UK (grant ES/S007393/1, RL). SVK acknowledges funding from NHS Research Scotland Senior Clinical Fellowship (SCAF/15/02, SVK), the MRC (MC_UU_00022/2, SVK), and the Scottish Government Chief Scientist Office (SPHSU17, SVK).en
dc.description.abstractBackground : Several countries restricted the administration of ChAdOx1 to older age groups in 2021 over safety concerns following case reports and observed versus expected analyses suggesting a possible association with cerebral venous sinus thrombosis (CVST). Large datasets are required to precisely estimate the association between Coronavirus Disease 2019 (COVID-19) vaccination and CVST due to the extreme rarity of this event. We aimed to accomplish this by combining national data from England, Scotland, and Wales. Methods and findings : We created data platforms consisting of linked primary care, secondary care, mortality, and virological testing data in each of England, Scotland, and Wales, with a combined cohort of 11,637,157 people and 6,808,293 person years of follow-up. The cohort start date was December 8, 2020, and the end date was June 30, 2021. The outcome measure we examined was incident CVST events recorded in either primary or secondary care records. We carried out a self-controlled case series (SCCS) analysis of this outcome following first dose vaccination with ChAdOx1 and BNT162b2. The observation period consisted of an initial 90-day reference period, followed by a 2-week prerisk period directly prior to vaccination, and a 4-week risk period following vaccination. Counts of CVST cases from each country were tallied, then expanded into a full dataset with 1 row for each individual and observation time period. There was a combined total of 201 incident CVST events in the cohorts (29.5 per million person years). There were 81 CVST events in the observation period among those who a received first dose of ChAdOx1 (approximately 16.34 per million doses) and 40 for those who received a first dose of BNT162b2 (approximately 12.60 per million doses). We fitted conditional Poisson models to estimate incidence rate ratios (IRRs). Vaccination with ChAdOx1 was associated with an elevated risk of incident CVST events in the 28 days following vaccination, IRR = 1.93 (95% confidence interval (CI) 1.20 to 3.11). We did not find an association between BNT162b2 and CVST in the 28 days following vaccination, IRR = 0.78 (95% CI 0.34 to 1.77). Our study had some limitations. The SCCS study design implicitly controls for variables that are constant over the observation period, but also assumes that outcome events are independent of exposure. This assumption may not be satisfied in the case of CVST, firstly because it is a serious adverse event, and secondly because the vaccination programme in the United Kingdom prioritised the clinically extremely vulnerable and those with underlying health conditions, which may have caused a selection effect for individuals more prone to CVST. Although we pooled data from several large datasets, there was still a low number of events, which may have caused imprecision in our estimates. Conclusions : In this study, we observed a small elevated risk of CVST events following vaccination with ChAdOx1, but not BNT162b2. Our analysis pooled information from large datasets from England, Scotland, and Wales. This evidence may be useful in risk–benefit analyses of vaccine policies and in providing quantification of risks associated with vaccination to the general public.
dc.format.extent17
dc.format.extent1039438
dc.language.isoeng
dc.relation.ispartofPLoS Medicineen
dc.subjectRA0421 Public health. Hygiene. Preventive Medicineen
dc.subject3rd-DASen
dc.subjectSDG 3 - Good Health and Well-beingen
dc.subject.lccRA0421en
dc.titleFirst dose ChAdOx1 and BNT162b2 COVID-19 vaccinations and cerebral venous sinus thrombosis : a pooled self-controlled case series study of 11.6 million individuals in England, Scotland, and Walesen
dc.typeJournal articleen
dc.contributor.institutionUniversity of St Andrews. School of Medicineen
dc.contributor.institutionUniversity of St Andrews. Population and Behavioural Science Divisionen
dc.contributor.institutionUniversity of St Andrews. Sir James Mackenzie Institute for Early Diagnosisen
dc.contributor.institutionUniversity of St Andrews. Education Divisionen
dc.identifier.doi10.1371/journal.pmed.1003927
dc.description.statusPeer revieweden


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