Safety of BNT162b2 or CoronaVac COVID-19 vaccines in patients with heart failure: A self-controlled case series study.

Autor:	Ye X; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China., Huang C; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China., Wei Y; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China., Li STH; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China., Yan VKC; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China., Yiu KH; Cardiology Division, Department of Medicine, School of Clinical Medicine, The University of Hong Kong, Hong Kong SAR, China.; Cardiac and Vascular Center, The University of Hong Kong-Shenzhen Hospital, Shenzhen 518053, China., Tse HF; Cardiology Division, Department of Medicine, School of Clinical Medicine, The University of Hong Kong, Hong Kong SAR, China.; Cardiac and Vascular Center, The University of Hong Kong-Shenzhen Hospital, Shenzhen 518053, China., Ma T; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.; Laboratory of Data Discovery for Health (D24H), Hong Kong SAR, China., Qin X; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.; Laboratory of Data Discovery for Health (D24H), Hong Kong SAR, China., Chui CSL; Laboratory of Data Discovery for Health (D24H), Hong Kong SAR, China.; School of Nursing, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.; School of Public Health, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China., Lai FTT; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.; Laboratory of Data Discovery for Health (D24H), Hong Kong SAR, China., Li X; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.; Laboratory of Data Discovery for Health (D24H), Hong Kong SAR, China.; Department of Medicine, School of Clinical Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China., Wan EYF; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.; Laboratory of Data Discovery for Health (D24H), Hong Kong SAR, China.; Department of Family Medicine and Primary Care, School of Clinical Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China., Wong CKH; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.; Laboratory of Data Discovery for Health (D24H), Hong Kong SAR, China.; Department of Family Medicine and Primary Care, School of Clinical Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China., Wong ICK; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.; Laboratory of Data Discovery for Health (D24H), Hong Kong SAR, China.; Research Department of Practice and Policy, School of Pharmacy, University College London, London, United Kingdom.; Aston Pharmacy School, Aston University, Birmingham, United Kingdom., Chan EW; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.; Laboratory of Data Discovery for Health (D24H), Hong Kong SAR, China.; Department of Pharmacy, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China.; The University of Hong Kong Shenzhen Institute of Research and Innovation, Shenzhen, China.
Jazyk:	angličtina
Zdroj:	The Lancet regional health. Western Pacific [Lancet Reg Health West Pac] 2023 Jan; Vol. 30, pp. 100630. Date of Electronic Publication: 2022 Nov 07.
DOI:	10.1016/j.lanwpc.2022.100630
Abstrakt:	Background: COVID-19 vaccines are important for patients with heart failure (HF) to prevent severe outcomes but the safety concerns could lead to vaccine hesitancy. This study aimed to investigate the safety of two COVID-19 vaccines, BNT162b2 and CoronaVac, in patients with HF. Methods: We conducted a self-controlled case series analysis using the data from the Hong Kong Hospital Authority and the Department of Health. The primary outcome was hospitalization for HF and the secondary outcomes were major adverse cardiovascular events (MACE) and all hospitalization. We identified patients with a history of HF before February 23, 2021 and developed the outcome event between February 23, 2021 and March 31, 2022 in Hong Kong. Incidence rate ratios (IRR) were estimated using conditional Poisson regression to evaluate the risks following the first three doses of BNT162b2 or CoronaVac. Findings: We identified 32,490 patients with HF, of which 3035 were vaccinated and had a hospitalization for HF during the observation period (BNT162b2 = 755; CoronaVac = 2280). There were no increased risks during the 0-13 days (IRR 0.64 [95% confidence interval 0.33-1.26]; 0.94 [0.50-1.78]; 0.82 [0.17-3.98]) and 14-27 days (0.73 [0.35-1.52]; 0.95 [0.49-1.84]; 0.60 [0.06-5.76]) after the first, second and third doses of BNT162b2. No increased risks were observed for CoronaVac during the 0-13 days (IRR 0.60 [0.41-0.88]; 0.71 [0.45-1.12]; 1.64 [0.40-6.77]) and 14-27 days (0.91 [0.63-1.32]; 0.79 [0.46-1.35]; 1.71 [0.44-6.62]) after the first, second and third doses. We also found no increased risk of MACE or all hospitalization after vaccination. Interpretation: Our results showed no increased risk of hospitalization for HF, MACE or all hospitalization after receiving BNT162b2 or CoronaVac vaccines in patients with HF. Funding: The project was funded by a Research Grant from the Food and Health Bureau, The Government of the Hong Kong Special Administrative Region (Ref. No. COVID19F01). F.T.T.L. (Francisco T.T. Lai) and I.C.K.W. (Ian C.K. Wong)'s posts were partly funded by the D24H; hence this work was partly supported by AIR@InnoHK administered by Innovation and Technology Commission. Competing Interests: C.S.L.C. has received grants from the Food and Health Bureau of the Hong Kong Government, Hong Kong Research Grant Council, Hong Kong Innovation and Technology Commission, Pfizer, IQVIA, and Amgen; personal fees from Primevigilance Ltd.; outside the submitted work. E.Y.F.W. has received research grants from the Food and Health Bureau of the Government of the Hong Kong SAR, and the Hong Kong Research Grants Council, outside the submitted work. F.T.T.L. has been supported by the RGC Postdoctoral Fellowship under the Hong Kong Research Grants Council and has received research grants from Food and Health Bureau of the Government of the Hong Kong SAR, outside the submitted work. X.L. received research grants from Research Fund Secretariat of the Food and Health Bureau (HMRF, HKSAR), Research Grants Council Early Career Scheme (RGC/ECS, HKSAR), Janssen and Pfizer; internal funding from the University of Hong Kong; consultancy fee from Merck Sharp & Dohme, unrelated to this work. I.C.K.W. reports research funding outside the submitted work from Amgen, Bristol-Myers Squibb, Pfizer, Janssen, Bayer, GSK, Novartis, the Hong Kong RGC, and the Hong Kong Health and Medical Research Fund, National Institute for Health Research in England, European Commission, National Health and Medical Research Council in Australia, and also received speaker fees from Janssen and Medice in the previous 3 years. He is also an independent non-executive director of Jacobson Medical in Hong Kong. E.W.C. has received research grants from Research Grants Council (RGC, HKSAR), Research Fund Secretariat of the Food and Health Bureau (HMRF, HKSAR), National Natural Science Fund of China, National Health and Medical research Council (NHMRC, Australia), Bayer, Bristol-Myers Squibb, Pfizer, Janssen, Amgen, Takeda, Novartis, and Narcotics Division of the Security Bureau of HKSAR; and honorarium from the Hospital Authority, outside the submitted work. All other authors declare no competing interests. (© 2022 The Authors.)
Databáze:	MEDLINE
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