Vascular thrombosis after single dose Ad26.COV2.S vaccine in healthcare workers in South Africa: open label, single arm, phase 3B study (Sisonke study)
Objective To assess the rates of vascular thrombotic adverse events in the first 35 days after one dose of the Ad26.COV2.S vaccine (Janssen/Johnson & Johnson) in healthcare workers in South Africa and to compare these rates with those observed in the general population.Design Open label, sin...
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BMJ Publishing Group
2023-11-01
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| Series: | BMJ Medicine |
| Online Access: | https://bmjmedicine.bmj.com/content/2/1/e000302.full |
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| author | Linda-Gail Bekker Glenda Gray Nigel Garrett Ameena Goga Amber Khan Ishen Seocharan Ian Sanne Jonny Peter Shirley Collie Nonhlanhla Yende-Zuma Barry Frank Jacobson Elise Schapkaitz Azwi Takalani Jessica Opie Tarylee Reddy Michelle Robinson Simbarashe Takuva Pradeep Rowji Vernon Johan Louw |
| author_facet | Linda-Gail Bekker Glenda Gray Nigel Garrett Ameena Goga Amber Khan Ishen Seocharan Ian Sanne Jonny Peter Shirley Collie Nonhlanhla Yende-Zuma Barry Frank Jacobson Elise Schapkaitz Azwi Takalani Jessica Opie Tarylee Reddy Michelle Robinson Simbarashe Takuva Pradeep Rowji Vernon Johan Louw |
| author_sort | Linda-Gail Bekker |
| collection | DOAJ |
| description | Objective To assess the rates of vascular thrombotic adverse events in the first 35 days after one dose of the Ad26.COV2.S vaccine (Janssen/Johnson & Johnson) in healthcare workers in South Africa and to compare these rates with those observed in the general population.Design Open label, single arm, phase 3B study.Setting Sisonke study, South Africa, 17 February to 15 June 2021.Participants The Sisonke cohort of 477 234 healthcare workers, aged ≥18 years, who received one dose of the Ad26.COV2.S vaccine.Main outcome measures Observed rates of venous arterial thromboembolism and vaccine induced immune thrombocytopenia and thrombosis in individuals who were vaccinated, compared with expected rates, based on age and sex specific background rates from the Clinical Practice Research Datalink GOLD database (database of longitudinal routinely collected electronic health records from UK primary care practices using Vision general practice patient management software).Results Most of the study participants were women (74.9%) and median age was 42 years (interquartile range 33-51). Twenty nine (30.6 per 100 000 person years, 95% confidence interval 20.5 to 44.0) vascular thrombotic events occurred at a median of 14 days (7-29) after vaccination. Of these 29 participants, 93.1% were women, median age 46 (37-55) years, and 51.7% had comorbidities. The observed to expected ratios for cerebral venous sinus thrombosis with thrombocytopenia and pulmonary embolism with thrombocytopenia were 10.6 (95% confidence interval 0.3 to 58.8) and 1.2 (0.1 to 6.5), respectively. Because of the small number of adverse events and wide confidence intervals, no conclusions were drawn between these estimates and the expected incidence rates in the population.Conclusions Vaccine induced immune thrombocytopenia and thrombosis after one dose of the Ad26.COV2.S vaccine was found in only a few patients in this South African population of healthcare workers. These findings are reassuring if considered in terms of the beneficial effects of vaccination against covid-19 disease. These data support the continued use of this vaccine, but surveillance is recommended to identify other incidences of venous and arterial thromboembolism and to improve confidence in the data estimates.Trial registration ClinicalTrials.gov NCT04838795. |
| format | Article |
| id | doaj-art-21279cd2d8d146c39b53664e453fd4e3 |
| institution | OA Journals |
| issn | 2754-0413 |
| language | English |
| publishDate | 2023-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Medicine |
| spelling | doaj-art-21279cd2d8d146c39b53664e453fd4e32025-08-20T02:31:46ZengBMJ Publishing GroupBMJ Medicine2754-04132023-11-012110.1136/bmjmed-2022-000302Vascular thrombosis after single dose Ad26.COV2.S vaccine in healthcare workers in South Africa: open label, single arm, phase 3B study (Sisonke study)Linda-Gail Bekker0Glenda Gray1Nigel Garrett2Ameena Goga3Amber Khan4Ishen Seocharan5Ian Sanne6Jonny Peter7Shirley Collie8Nonhlanhla Yende-Zuma9Barry Frank Jacobson10Elise Schapkaitz11Azwi Takalani12Jessica Opie13Tarylee Reddy14Michelle Robinson15Simbarashe Takuva16Pradeep Rowji17Vernon Johan Louw18Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South AfricaHIV and Other Infectious Diseases Research Unit, South African Medical Research Council, Cape Town, South AfricaCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, KwaZulu-Natal, South AfricaHIV and Other Infectious Diseases Research Unit, South African Medical Research Council, Cape Town, South AfricaMolecular Medicine and Haematology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaBiostatistics Research Unit, South African Medical Research Council, Durban, South AfricaClinical HIV Research Unit, University of the Witwatersrand Faculty of Sciences, Johannesburg, South AfricaDivision of Allergy and Clinical Immunology, Faculty of Health Sciences, University of Cape Town, Cape Town, South AfricaDiscovery Health, Johannesburg, South AfricaNelson R Mandela School of Medicine, Centre for the AIDS Programme of Research in South Africa, University of KwaZulu Natal, Durban, South AfricaMolecular Medicine and Haematology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaMolecular Medicine and Haematology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaHutchinson Centre Research Institute of South Africa (HCRISA), Chris Hani Baragwanath Hospital, Johannesburg, South AfricaDivision of Haematology, Department of Pathology, University of Cape Town and National Health Laboratory Service, Cape Town, South AfricaBiostatistics Research Unit, South African Medical Research Council, Durban, South AfricaRight To Care, Johannesburg, South AfricaSchool of Health Systems and Public Health, University of Pretoria, Faculty of Health Sciences, Pretoria, South AfricaThe Southern African Society of Thrombosis and Haemostasis, Neurology Association of South Africa, Johannesburg, South AfricaDivision of Clinical Haematology, Department of Medicine, Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital, Cape Town, South AfricaObjective To assess the rates of vascular thrombotic adverse events in the first 35 days after one dose of the Ad26.COV2.S vaccine (Janssen/Johnson & Johnson) in healthcare workers in South Africa and to compare these rates with those observed in the general population.Design Open label, single arm, phase 3B study.Setting Sisonke study, South Africa, 17 February to 15 June 2021.Participants The Sisonke cohort of 477 234 healthcare workers, aged ≥18 years, who received one dose of the Ad26.COV2.S vaccine.Main outcome measures Observed rates of venous arterial thromboembolism and vaccine induced immune thrombocytopenia and thrombosis in individuals who were vaccinated, compared with expected rates, based on age and sex specific background rates from the Clinical Practice Research Datalink GOLD database (database of longitudinal routinely collected electronic health records from UK primary care practices using Vision general practice patient management software).Results Most of the study participants were women (74.9%) and median age was 42 years (interquartile range 33-51). Twenty nine (30.6 per 100 000 person years, 95% confidence interval 20.5 to 44.0) vascular thrombotic events occurred at a median of 14 days (7-29) after vaccination. Of these 29 participants, 93.1% were women, median age 46 (37-55) years, and 51.7% had comorbidities. The observed to expected ratios for cerebral venous sinus thrombosis with thrombocytopenia and pulmonary embolism with thrombocytopenia were 10.6 (95% confidence interval 0.3 to 58.8) and 1.2 (0.1 to 6.5), respectively. Because of the small number of adverse events and wide confidence intervals, no conclusions were drawn between these estimates and the expected incidence rates in the population.Conclusions Vaccine induced immune thrombocytopenia and thrombosis after one dose of the Ad26.COV2.S vaccine was found in only a few patients in this South African population of healthcare workers. These findings are reassuring if considered in terms of the beneficial effects of vaccination against covid-19 disease. These data support the continued use of this vaccine, but surveillance is recommended to identify other incidences of venous and arterial thromboembolism and to improve confidence in the data estimates.Trial registration ClinicalTrials.gov NCT04838795.https://bmjmedicine.bmj.com/content/2/1/e000302.full |
| spellingShingle | Linda-Gail Bekker Glenda Gray Nigel Garrett Ameena Goga Amber Khan Ishen Seocharan Ian Sanne Jonny Peter Shirley Collie Nonhlanhla Yende-Zuma Barry Frank Jacobson Elise Schapkaitz Azwi Takalani Jessica Opie Tarylee Reddy Michelle Robinson Simbarashe Takuva Pradeep Rowji Vernon Johan Louw Vascular thrombosis after single dose Ad26.COV2.S vaccine in healthcare workers in South Africa: open label, single arm, phase 3B study (Sisonke study) BMJ Medicine |
| title | Vascular thrombosis after single dose Ad26.COV2.S vaccine in healthcare workers in South Africa: open label, single arm, phase 3B study (Sisonke study) |
| title_full | Vascular thrombosis after single dose Ad26.COV2.S vaccine in healthcare workers in South Africa: open label, single arm, phase 3B study (Sisonke study) |
| title_fullStr | Vascular thrombosis after single dose Ad26.COV2.S vaccine in healthcare workers in South Africa: open label, single arm, phase 3B study (Sisonke study) |
| title_full_unstemmed | Vascular thrombosis after single dose Ad26.COV2.S vaccine in healthcare workers in South Africa: open label, single arm, phase 3B study (Sisonke study) |
| title_short | Vascular thrombosis after single dose Ad26.COV2.S vaccine in healthcare workers in South Africa: open label, single arm, phase 3B study (Sisonke study) |
| title_sort | vascular thrombosis after single dose ad26 cov2 s vaccine in healthcare workers in south africa open label single arm phase 3b study sisonke study |
| url | https://bmjmedicine.bmj.com/content/2/1/e000302.full |
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