Evidence map›Paper›PMID 36288813›Full record

SynthesisBMJ (Clinical research ed.)2022

Comparative risk of thrombosis with thrombocytopenia syndrome or thromboembolic events associated with different covid-19 vaccines: international network cohort study from five European countries and the US.

Xintong Li, Edward Burn, Talita Duarte-Salles, Can Yin, Christian Reich, Antonella Delmestri, Katia Verhamme, Peter Rijnbeek, Marc A Suchard, Kelly Li and 7 more

Open access · hybridAbstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in BMJ (Clinical research ed.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
12.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 61 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 7 institutions in 4 countries.

Xintong LiCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.ORCID 0000-0002-6872-5804
Edward BurnCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK Edward.burn@ndorms.ox.ac.uk.ORCID 0000-0002-9286-1128
Talita Duarte-SallesFundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.
Can YinReal World Solutions, IQVIA, Durham, NC, USA.
Christian ReichReal World Solutions, IQVIA, Durham, NC, USA.
Antonella DelmestriCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Katia VerhammeDepartment of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands.
Peter RijnbeekDepartment of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands.
Marc A SuchardDepartment of Biostatistics, Fielding School of Public Health, University of California, Los Angeles, Los Angeles, CA, USA.
Kelly LiDepartment of Biostatistics, Fielding School of Public Health, University of California, Los Angeles, Los Angeles, CA, USA.
Mees MosseveldDepartment of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands.
Luis H JohnDepartment of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands.
Miguel-Angel MayerResearch Programme on Biomedical Informatics, Hospital del Mar Medical Research Institute, Faculty of Health and Life Sciences, University of Pompeu Fabra, Barcelona, Spain.
Juan-Manuel Ramirez-AnguitaResearch Programme on Biomedical Informatics, Hospital del Mar Medical Research Institute, Faculty of Health and Life Sciences, University of Pompeu Fabra, Barcelona, Spain.
Catherine CohetData Analytics and Methods Task Force, European Medicines Agency, Amsterdam, Netherlands.
Victoria StraussCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Daniel Prieto-AlhambraCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Nuffield Orthopaedic Centre · GBErasmus MC · NLIQVIA (United States) · USUniversitat Pompeu Fabra · ESUniversity of California, Los Angeles · USEuropean Medicines Agency · NLInstitut Universitari d'Investigació en Atenció Primària Jordi Gol · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo quantify the comparative risk of thrombosis with thrombocytopenia syndrome or thromboembolic events associated with use of adenovirus based covid-19 vaccines versus mRNA based covid-19 vaccines.

designInternational network cohort study.

settingRoutinely collected health data from contributing datasets in France, Germany, the Netherlands, Spain, the UK, and the US.

participantsAdults (age ≥18 years) registered at any contributing database and who received at least one dose of a covid-19 vaccine (ChAdOx1-S (Oxford-AstraZeneca), BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), or Ad26.COV2.S (Janssen/Johnson & Johnson)), from December 2020 to mid-2021.

main outcome measuresThrombosis with thrombocytopenia syndrome or venous or arterial thromboembolic events within the 28 days after covid-19 vaccination. Incidence rate ratios were estimated after propensity scores matching and were calibrated using negative control outcomes. Estimates specific to the database were pooled by use of random effects meta-analyses.

resultsOverall, 1 332 719 of 3 829 822 first dose ChAdOx1-S recipients were matched to 2 124 339 of 2 149 679 BNT162b2 recipients from Germany and the UK. Additionally, 762 517 of 772 678 people receiving Ad26.COV2.S were matched to 2 851 976 of 7 606 693 receiving BNT162b2 in Germany, Spain, and the US. All 628 164 Ad26.COV2.S recipients from the US were matched to 2 230 157 of 3 923 371 mRNA-1273 recipients. A total of 862 thrombocytopenia events were observed in the matched first dose ChAdOx1-S recipients from Germany and the UK, and 520 events after a first dose of BNT162b2. Comparing ChAdOx1-S with a first dose of BNT162b2 revealed an increased risk of thrombocytopenia (pooled calibrated incidence rate ratio 1.33 (95% confidence interval 1.18 to 1.50) and calibrated incidence rate difference of 1.18 (0.57 to 1.8) per 1000 person years). Additionally, a pooled calibrated incidence rate ratio of 2.26 (0.93 to 5.52) for venous thrombosis with thrombocytopenia syndrome was seen with Ad26.COV2.S compared with BNT162b2.

conclusionsIn this multinational study, a pooled 30% increased risk of thrombocytopenia after a first dose of the ChAdOx1-S vaccine was observed, as was a trend towards an increased risk of venous thrombosis with thrombocytopenia syndrome after Ad26.COV2.S compared with BNT162b2. Although rare, the observed risks after adenovirus based vaccines should be considered when planning further immunisation campaigns and future vaccine development.

Indexed as

COVID-19 VaccinesThrombocytopeniaThromboembolismThrombosisAd26COVS1AdolescentAdultBNT162 VaccineCohort StudiesCOVID-19HumansVenous ThrombosisAd26COVS1BNT162 VaccineCOVID-19 Vaccines

Identifiers

PMID36288813
PMCPMC9597610
OpenAlexW4307640332

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.