EClinicalMedicine (Aug 2022)
Thromboembolic events and hemorrhagic stroke after mRNA (BNT162b2) and inactivated (CoronaVac) covid-19 vaccination: A self-controlled case series study
- Celine Sze Ling Chui,
- Min Fan,
- Eric Yuk Fai Wan,
- Miriam Tim Yin Leung,
- Edmund Cheung,
- Vincent Ka Chun Yan,
- Le Gao,
- Yonas Ghebremichael-Weldeselassie,
- Kenneth K.C. Man,
- Kui Kai Lau,
- Ivan Chun Hang Lam,
- Francisco Tsz Tsun Lai,
- Xue Li,
- Carlos King Ho Wong,
- Esther W. Chan,
- Ching-Lung Cheung,
- Chor-Wing Sing,
- Cheuk Kwong Lee,
- Ivan Fan Ngai Hung,
- Chak Sing Lau,
- Joseph Yat Sun Chan,
- Michael Kang-Yin Lee,
- Vincent Chung Tong Mok,
- Chung-Wah Siu,
- Lot Sze Tao Chan,
- Terence Cheung,
- Frank Ling Fung Chan,
- Anskar Yu-Hung Leung,
- Benjamin John Cowling,
- Gabriel Matthew Leung,
- Ian Chi Kei Wong
Affiliations
- Celine Sze Ling Chui
- School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.; School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China; Laboratory of Data Discovery for Health (D24H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China
- Min Fan
- Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China
- Eric Yuk Fai Wan
- Laboratory of Data Discovery for Health (D24H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China; Department of Family Medicine and Primary Care, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, SAR, China
- Miriam Tim Yin Leung
- Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China
- Edmund Cheung
- Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China
- Vincent Ka Chun Yan
- Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China
- Le Gao
- Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China
- Yonas Ghebremichael-Weldeselassie
- Division of Health Sciences, Warwick Medical School, Gibbet Hill, University of Warwick, Warwick, Coventry, UK
- Kenneth K.C. Man
- Research Department of Practice and Policy, School of Pharmacy, University College London, United Kingdom
- Kui Kai Lau
- Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, SAR, China; The State Key Laboratory of Brain and Cognitive Sciences, The University of Hong Kong, Hong Kong SAR, China
- Ivan Chun Hang Lam
- Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China
- Francisco Tsz Tsun Lai
- Laboratory of Data Discovery for Health (D24H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China
- Xue Li
- Laboratory of Data Discovery for Health (D24H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China; Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, SAR, China
- Carlos King Ho Wong
- Laboratory of Data Discovery for Health (D24H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China; Department of Family Medicine and Primary Care, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, SAR, China
- Esther W. Chan
- Laboratory of Data Discovery for Health (D24H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China
- Ching-Lung Cheung
- Laboratory of Data Discovery for Health (D24H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China
- Chor-Wing Sing
- Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China
- Cheuk Kwong Lee
- Hong Kong Red Cross Blood Transfusion Service, Hospital Authority, Hong Kong, China; Expert Committee on Clinical Events Assessment Following COVID-19 Immunization, Department of Health, The Government of the Hong Kong Special Administrative Region, Hong Kong, SAR, China
- Ivan Fan Ngai Hung
- Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, SAR, China; Expert Committee on Clinical Events Assessment Following COVID-19 Immunization, Department of Health, The Government of the Hong Kong Special Administrative Region, Hong Kong, SAR, China
- Chak Sing Lau
- Division of Rheumatology and Clinical Immunology, Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, SAR, China
- Joseph Yat Sun Chan
- Division of Cardiology, Department of Medicine and Therapeutics, Prince of Wales Hospital, Hong Kong, The Chinese University of Hong Kong, Hong Kong
- Michael Kang-Yin Lee
- Expert Committee on Clinical Events Assessment Following COVID-19 Immunization, Department of Health, The Government of the Hong Kong Special Administrative Region, Hong Kong, SAR, China; Queen Elizabeth Hospital, Hospital Authority, Hong Kong, China
- Vincent Chung Tong Mok
- Expert Committee on Clinical Events Assessment Following COVID-19 Immunization, Department of Health, The Government of the Hong Kong Special Administrative Region, Hong Kong, SAR, China; Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, SAR, China
- Chung-Wah Siu
- Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, SAR, China
- Lot Sze Tao Chan
- Department of Health, The Government of the Hong Kong Special Administrative Region, Hong Kong, SAR, China
- Terence Cheung
- Department of Health, The Government of the Hong Kong Special Administrative Region, Hong Kong, SAR, China
- Frank Ling Fung Chan
- Department of Health, The Government of the Hong Kong Special Administrative Region, Hong Kong, SAR, China
- Anskar Yu-Hung Leung
- Division of Hematology, Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, SAR, China
- Benjamin John Cowling
- School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China; Laboratory of Data Discovery for Health (D24H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China
- Gabriel Matthew Leung
- School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China; Laboratory of Data Discovery for Health (D24H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China
- Ian Chi Kei Wong
- Laboratory of Data Discovery for Health (D24H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong, SAR, China; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China; Research Department of Practice and Policy, School of Pharmacy, University College London, United Kingdom; Expert Committee on Clinical Events Assessment Following COVID-19 Immunization, Department of Health, The Government of the Hong Kong Special Administrative Region, Hong Kong, SAR, China; Corresponding author at: L2-57, Laboratory Block, 21 Sassoon Road, Pokfulam, Hong Kong
- Journal volume & issue
-
Vol. 50
p. 101504
Abstract
Summary: Background: This study aims to evaluate the association between thromboembolic events and hemorrhagic stroke following BNT162b2 and CoronaVac vaccination. Methods: Patients with incident thromboembolic events or hemorrhagic stroke within 28 days of covid-19 vaccination or SARS-CoV-2 positive test during 23 February to 30 September 2021 were included. The incidence per 100,000 covid-19 vaccine doses administered and SARS-CoV-2 test positive cases were estimated. A modified self-controlled case series (SCCS) analysis using the data from the Hong Kong territory-wide electronic health and vaccination records. Seasonal effect was adjusted by month. Findings: A total of 5,526,547 doses of BNT162b2 and 3,146,741 doses of CoronaVac were administered. A total of 334 and 402 thromboembolic events, and 57 and 49 hemorrhagic stroke cases occurred within 28 days after BNT162b2 and CoronaVac vaccination, respectively. The crude incidence of thromboembolic events and hemorrhagic stroke per 100,000 doses administered for both covid-19 vaccines were smaller than that per 100,000 SARS-CoV-2 test positive cases. The modified SCCS detected an increased risk of hemorrhagic stroke in BNT162b2 14-27 days after first dose with adjusted IRR of 2.53 (95% CI 1.48-4.34), and 0-13 days after second dose with adjusted IRR 2.69 (95% CI 1.54-4.69). No statistically significant risk was observed for thromboembolic events for both vaccines. Interpretation: We detected a possible safety signal for hemorrhagic stroke following BNT162b2 vaccination. The incidence of thromboembolic event or hemorrhagic stroke following vaccination is lower than that among SARS-CoV-2 test positive cases; therefore, vaccination against covid-19 remains an important public health intervention. Funding: This study was funded by a research grant from the Food and Health Bureau, The Government of the Hong Kong Special Administrative Region (reference COVID19F01).
