Safety of Inactivated and mRNA COVID-19 Vaccination Among Patients Treated for Hypothyroidism: A Population-Based Cohort Study
Abstract
Background: Thyroiditis and Graves' disease have been reported after coronavirus disease 2019 (COVID-19) vaccination. We evaluated the risks of adverse events after COVID-19 vaccination among patients treated for hypothyroidism.
Methods: In this retrospective population-based cohort study of Hong Kong Hospital Authority electronic health records with the Department of Health vaccination records linkage, levothyroxine (LT4) users were categorized into unvaccinated, vaccinated with BNT162b2 (mRNA vaccine), or CoronaVac (inactivated vaccine) between February 23, 2021, and September 9, 2021. Study outcomes were dosage reduction or escalation in LT4, emergency department (ED) visit, unscheduled hospitalization, adverse events of special interest (AESI) according to the World Health Organization's Global Advisory Committee on Vaccine Safety, and all-cause mortality. Inverse probability of treatment weighting for propensity score was applied to balance baseline patient characteristics among the three groups. Hazard ratios (HR) were estimated using Cox regression models. Patients were observed from the index date until the occurrence of study outcome, death, or censored on September 30, 2021, whichever came first.
Results: In total, 47,086 LT4 users were identified (BNT162b2: n = 12,310; CoronaVac: n = 11,353; and unvaccinated: n = 23,423). COVID-19 vaccination was not associated with increased risks of LT4 dosage reduction (BNT162b2: HR = 0.971 [confidence interval; CI 0.892–1.058]; CoronaVac: HR = 0.968 [CI 0.904–1.037]) or escalation (BNT162b2: HR = 0.779 [CI 0.519–1.169]; CoronaVac: HR = 0.715 [CI 0.481–1.062]). Besides, COVID-19 vaccination was not associated with a higher risk of ED visits (BNT162b2: HR = 0.944 [CI 0.700–1.273]; CoronaVac: HR = 0.851 [CI 0.647–1.120]) or unscheduled hospitalization (BNT162b2: HR = 0.905 [CI 0.539–1.520]; CoronaVac: HR = 0.735 [CI 0.448–1.207]). There were two (0.016%) deaths and six (0.062%) AESI recorded for BNT162b2 recipients, and one (0.009%) and three (0.035%) for CoronaVac recipients, respectively.
Conclusions: BNT162b2 or CoronaVac vaccination is not associated with unstable thyroid status or an increased risk of adverse outcomes among patients treated for hypothyroidism in general. These reassuring data should encourage them to get vaccinated against COVID-19 for protection from potentially worse COVID-19-related outcomes.
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Copyright 2022, Mary Ann Liebert, Inc., publishers.
History
Published online: 17 May 2022
Published in print: May 2022
Published ahead of print: 7 April 2022
Published ahead of production: 25 February 2022
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Authors' Contributions
D.T.W.L., C.K.H.W., and X.X. reviewed the literature, designed the statistical analysis, conducted analyses, and wrote the article. X.X., C.K.H.W., D.T.W.L., and K.T.K.L. reviewed the literature, contributed to the interpretation of analysis, and wrote the article. X.X. and I.C.H.A. conducted the analyses. C.K.H.W., F.T.T.L., X.L., E.Y.F.W., C.S.L.C., E.W.Y.C., F.W.T.C., C.H.L., Y.-C.W., D.T.W.L., and I.C.K.W. contributed to the interpretation of the analysis, and critically reviewed and revised the article. All authors contributed to the interpretation of the analysis, critically reviewed and revised the article, and approved the final article as submitted. The corresponding author attests that all listed authors meet the authorship criteria and that no others meeting the criteria have been omitted.
Author Disclosure Statement
C.K.H.W. reports receipt of research funding from the EuroQOL Group Research Foundation, the Hong Kong Research Grants Council, and the Hong Kong Health and Medical Research Fund. F.T.T.L. has been supported by the RGC Postdoctoral Fellowship under the Hong Kong Research Grants Council. X.L. has received research grants from the Food and Health Bureau of the Government of the Hong Kong SAR, research and educational grants from Janssen and Pfizer; internal funding from the University of Hong Kong; consultancy fee from Merck Sharp & Dohme, unrelated to this 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. 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 fee from PrimeVigilance Ltd.; outside the submitted work.
E.W.Y.C. reports honorarium from Hospital Authority, grants from Research Grants Council (RGC, Hong Kong), grants from Research Fund Secretariat of the Food and Health Bureau, grants from the National Natural Science Fund of China, grants from Wellcome Trust, grants from Bayer, grants from Bristol-Myers Squibb, grants from Pfizer, grants from Janssen, grants from Amgen, grants from Takeda, and grants from Narcotics Division of the Security Bureau of HKSAR, outside the submitted 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, the 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 three years.
Funding Information
Research Grant from the Food and Health Bureau, The Government of the Hong Kong Special Administrative Region (Ref. No. COVID19F01). The funders did not have any role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the article; and decision to submit the article for publication.
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