Thrombocytopenic, thromboembolic and haemorrhagic events following second dose with BNT162b2 and ChAdOx1: self-controlled case series analysis of the English national sentinel cohort.

Autor:	Joy M; Nuffield Department of Primary Care Health Sciences, University of Oxford, UK., Agrawal U; Nuffield Department of Primary Care Health Sciences, University of Oxford, UK., Fan X; Nuffield Department of Primary Care Health Sciences, University of Oxford, UK., Robertson C; Department of Mathematics and Statistics, University of Strathclyde, Glasgow, UK.; Public Health Scotland, Glasgow, UK., Anand SN; Nuffield Department of Primary Care Health Sciences, University of Oxford, UK., Ordonez-Mena J; Nuffield Department of Primary Care Health Sciences, University of Oxford, UK., Byford R; Nuffield Department of Primary Care Health Sciences, University of Oxford, UK., Goudie R; Nuffield Department of Primary Care Health Sciences, University of Oxford, UK., Jamie G; Nuffield Department of Primary Care Health Sciences, University of Oxford, UK., Kar D; Nuffield Department of Primary Care Health Sciences, University of Oxford, UK., Williams J; Nuffield Department of Primary Care Health Sciences, University of Oxford, UK., Marsden GL; Royal College of General Practitioners, London, UK., Tzortziou-Brown V; Royal College of General Practitioners, London, UK., Sheikh SA; Usher Institute, The University of Edinburgh, Edinburgh, UK., Hobbs FDR; Nuffield Department of Primary Care Health Sciences, University of Oxford, UK., de Lusignan S; Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.
Jazyk:	angličtina
Zdroj:	The Lancet regional health. Europe [Lancet Reg Health Eur] 2023 Jul 18; Vol. 32, pp. 100681. Date of Electronic Publication: 2023 Jul 18 (Print Publication: 2023).
DOI:	10.1016/j.lanepe.2023.100681
Abstrakt:	Background: Thrombosis associated with thrombocytopenia was a matter of concern post first and second doses of BNT162b2 and ChAdOx1 COVID-19 vaccines. Therefore, it is important to investigate the risk of thrombocytopenic, thromboembolic and haemorrhagic events following a second dose of BNT162b2 and ChAdOx1 COVID-19 vaccines. Methods: We conducted a large-scale self-controlled case series analysis, using routine primary care data linked to hospital data, among 12.3 million individuals (16 years old and above) in England. We used the nationally representative Oxford-Royal College of General Practitioners (RCGP) sentinel network database with baseline and risk periods between 8th December 2020 and 11th June 2022. We included individuals who received two vaccine (primary) doses of the BNT162b2 mRNA (Pfizer-BioNTech) and two vaccine doses of ChAdOx1 nCoV-19 (Oxford-AstraZeneca) vaccines in our analyses. We carried out a self-controlled case series (SCCS) analysis for each outcome using a conditional Poisson regression model with an offset for the length of risk period. We reported the incidence rate ratios (IRRs) and 95% confidence intervals (CI) of thrombocytopenic, thromboembolic (including arterial and venous events) and haemorrhagic events, in the period of 0-27 days after receiving a second dose of BNT162b2 or ChAdOx1 vaccines compared to the baseline period (14 or more days prior to first dose, 28 or more days after the second dose and the time between 28 or more days after the first and 14 or more days prior to the second dose). We adjusted for a range of potential confounders, including age, sex, comorbidities and deprivation. Findings: Between December 8, 2020 and February 11, 2022, 6,306,306 individuals were vaccinated with two doses of BNT162b2 and 6,046,785 individuals were vaccinated with two doses of ChAdOx1. Compared to the baseline, our analysis show no increased risk of venous thromboembolic events (VTE) for both BNT162b2 (IRR 0.71, 95% CI: 0.65-0.770) and ChAdOx1 (IRR 0.91, 95% CI: 0.84-0.98); and similarly there was no increased risk for cerebral venous sinus thrombosis (CVST) for both BNT162b2 (IRR 0.87, 95% CI: 0.41-1.85) and ChAdOx1 (IRR 1.73, 95% CI: 0.82-3.68). We additionally report no difference in IRR for pulmonary embolus, and deep vein thrombosis, thrombocytopenia, including idiopathic thrombocytopenic purpura (ITP), and haemorrhagic events post second dose for both BNT162b2. Interpretation: Reassuringly, we found no associations between increased risk of thrombocytopenic, thromboembolic and haemorrhagic events post vaccination with second dose for either of these vaccines. Funding: Data and Connectivity: COVID-19 Vaccines Pharmacovigilance study. Competing Interests: SdeL is Director of the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC). SdeL has received funding for vaccine related research from AstraZeneca, GSK, Sanofi, Seqirus and Takeda, and been members of advisory boards for AstraZeneca, Sanofi and Seqirus all through his university. The AstraZeneca studies include ATTEST a study of Thrombotic Thrombocytopenia (SdeL is PI and MJ and FDRH Co–I). JMOM has previously worked on vaccine related project funded by AstraZeneca. GJ has previously presented to healthcare professionals on heart failure treatment which was funded by AstraZeneca. FDRH has previously received consultation fees on MAbs and vaccines from AstraZeneca and Pfizer. FDRH has previously received fees for presenting at Cardio-vascular diseases and COVID-19 related events organised by AstraZeneca, Pfizer, Boehringer Ingelheim and Bristol Myers Squibb. AS and CR are members of the Scottish Government's CMO COVID-19 Advisory Group and its Standing Committee on Pandemics. AS was a member of AstraZeneca's Thrombotic Thrombocytopenic Taskforce and all of his roles are unremunerated. CR is a member of the Scientific Pandemic Influenza Group on Modelling, Medicines and Healthcare products Regulatory Agency Vaccine Benefit and Risk Working Group. CR also received support from Public Health Scotland, MRC and CSO. VTB is member of various NHSE advisory boards on issues related to NHS workforce and workload, UK Health Alliance on Climate Change on behalf of RCGP and Our Future Health advisory board on behalf of RCGP. VTB held leadership positions as RCGP Vice Chair, BMA member, FSEM member, FSRH member, SAPC member and exec member (from July 2022), Founding participant of Health Foundation Q initiative, Member of the Allocations Steering Group-NHS England and Improvement, Member of NIHR Primary Care Strategy group, Council member and Senior Founding Fellow of Faculty of Medical Leadership and Management, NED Turning Point. VTB has previously received expenses for RCGP events, Nuffield Trust events and HSJ events. All other authors declare no competing interests. (© 2023 The Authors.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu