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Risk of thrombocytopenia and thromboembolism after covid-19 vaccination and SARS-CoV-2 positive testing: self-controlled case series study.
Hippisley-Cox, Julia; Patone, Martina; Mei, Xue W; Saatci, Defne; Dixon, Sharon; Khunti, Kamlesh; Zaccardi, Francesco; Watkinson, Peter; Shankar-Hari, Manu; Doidge, James; Harrison, David A; Griffin, Simon J; Sheikh, Aziz; Coupland, Carol A C.
  • Hippisley-Cox J; Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK julia.hippisley-cox@phc.ox.ac.uk.
  • Patone M; Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK.
  • Mei XW; Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK.
  • Saatci D; Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK.
  • Dixon S; Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK.
  • Khunti K; Leicester Real World Evidence Unit, Leicester Diabetes Centre, University of Leicester, Leicester, UK.
  • Zaccardi F; Leicester Real World Evidence Unit, Leicester Diabetes Centre, University of Leicester, Leicester, UK.
  • Watkinson P; Nuffield Department of Clinical Neurosciences, University of Oxford, NIHR Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, UK.
  • Shankar-Hari M; Intensive Care National Audit & Research Centre, London, UK.
  • Doidge J; Department of Critical Care Medicine, Guys and St Thomas' NHS Foundation Trust, London, UK.
  • Harrison DA; Intensive Care National Audit & Research Centre, London, UK.
  • Griffin SJ; Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
  • Sheikh A; Intensive Care National Audit & Research Centre, London, UK.
  • Coupland CAC; Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
BMJ ; 374: n1931, 2021 08 26.
Article in English | MEDLINE | ID: covidwho-1376469
ABSTRACT

OBJECTIVE:

To assess the association between covid-19 vaccines and risk of thrombocytopenia and thromboembolic events in England among adults.

DESIGN:

Self-controlled case series study using national data on covid-19 vaccination and hospital admissions.

SETTING:

Patient level data were obtained for approximately 30 million people vaccinated in England between 1 December 2020 and 24 April 2021. Electronic health records were linked with death data from the Office for National Statistics, SARS-CoV-2 positive test data, and hospital admission data from the United Kingdom's health service (NHS).

PARTICIPANTS:

29 121 633 people were vaccinated with first doses (19 608 008 with Oxford-AstraZeneca (ChAdOx1 nCoV-19) and 9 513 625 with Pfizer-BioNTech (BNT162b2 mRNA)) and 1 758 095 people had a positive SARS-CoV-2 test. People aged ≥16 years who had first doses of the ChAdOx1 nCoV-19 or BNT162b2 mRNA vaccines and any outcome of interest were included in the study. MAIN OUTCOME

MEASURES:

The primary outcomes were hospital admission or death associated with thrombocytopenia, venous thromboembolism, and arterial thromboembolism within 28 days of three exposures first dose of the ChAdOx1 nCoV-19 vaccine; first dose of the BNT162b2 mRNA vaccine; and a SARS-CoV-2 positive test. Secondary outcomes were subsets of the primary

outcomes:

cerebral venous sinus thrombosis (CVST), ischaemic stroke, myocardial infarction, and other rare arterial thrombotic events.

RESULTS:

The study found increased risk of thrombocytopenia after ChAdOx1 nCoV-19 vaccination (incidence rate ratio 1.33, 95% confidence interval 1.19 to 1.47 at 8-14 days) and after a positive SARS-CoV-2 test (5.27, 4.34 to 6.40 at 8-14 days); increased risk of venous thromboembolism after ChAdOx1 nCoV-19 vaccination (1.10, 1.02 to 1.18 at 8-14 days) and after SARS-CoV-2 infection (13.86, 12.76 to 15.05 at 8-14 days); and increased risk of arterial thromboembolism after BNT162b2 mRNA vaccination (1.06, 1.01 to 1.10 at 15-21 days) and after SARS-CoV-2 infection (2.02, 1.82 to 2.24 at 15-21 days). Secondary analyses found increased risk of CVST after ChAdOx1 nCoV-19 vaccination (4.01, 2.08 to 7.71 at 8-14 days), after BNT162b2 mRNA vaccination (3.58, 1.39 to 9.27 at 15-21 days), and after a positive SARS-CoV-2 test; increased risk of ischaemic stroke after BNT162b2 mRNA vaccination (1.12, 1.04 to 1.20 at 15-21 days) and after a positive SARS-CoV-2 test; and increased risk of other rare arterial thrombotic events after ChAdOx1 nCoV-19 vaccination (1.21, 1.02 to 1.43 at 8-14 days) and after a positive SARS-CoV-2 test.

CONCLUSION:

Increased risks of haematological and vascular events that led to hospital admission or death were observed for short time intervals after first doses of the ChAdOx1 nCoV-19 and BNT162b2 mRNA vaccines. The risks of most of these events were substantially higher and more prolonged after SARS-CoV-2 infection than after vaccination in the same population.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Thrombocytopenia / Thromboembolism / Vaccination / COVID-19 Vaccines / COVID-19 Subject: Thrombocytopenia / Thromboembolism / Vaccination / COVID-19 Vaccines / COVID-19 Type of study: Diagnostic study / Etiology study / Risk factors Language: English Journal: BMJ Clinical aspect: Etiology Year: 2021

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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Thrombocytopenia / Thromboembolism / Vaccination / COVID-19 Vaccines / COVID-19 Subject: Thrombocytopenia / Thromboembolism / Vaccination / COVID-19 Vaccines / COVID-19 Type of study: Diagnostic study / Etiology study / Risk factors Language: English Journal: BMJ Clinical aspect: Etiology Year: 2021
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