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Subacute thyroiditis and COVID-19 vaccines: a case/non-case study.
Montserrat García1, Itziar Albizua-Madariaga2, Unax Lertxundi3
1Osakidetza Basque Health Service, Galdakao-Usansolo Hospital, Basque Country Pharmacovigilance Unit, Biocruces Bizkaia Health Research Institute, Barrio Labeaga 46 A, Galdakao, 48960, Spain. farmacovigilancia@osakidetza.eus.
Endocrine
|June 9, 2022
Summary
This study investigated COVID-19 vaccines and subacute thyroiditis (SAT). mRNA COVID-19 vaccines showed a disproportionate reporting of SAT compared to other viral vaccines in the EudraVigilance database.
Area of Science:
- Pharmacovigilance
- Endocrinology
- Vaccinology
Background:
- Case reports suggest a link between COVID-19 vaccines and subacute thyroiditis (SAT).
- No prior studies have systematically analyzed this potential association.
- The EudraVigilance database contains reports of adverse reactions to vaccines.
Purpose of the Study:
- To determine if there is a disproportionate reporting of SAT cases associated with four COVID-19 vaccines.
- To analyze the association between specific COVID-19 vaccines (BNT162b2, mRNA-1273, ChAdOx1-S, Ad26.COV2.S) and SAT.
Main Methods:
- A case/non-case study design was employed.
- Data from the EudraVigilance database up to December 2, 2021, were analyzed.
- Reporting Odds Ratios (RORs) were calculated to assess the association between SAT and COVID-19 vaccines compared to other drugs and viral vaccines.
Main Results:
- Out of 1,221,582 adverse reaction reports, 162 cases of SAT were identified.
- SAT was reported more frequently with BNT162b2, mRNA-1273, and ChAdOx1-S vaccines compared to other drugs.
- A disproportionate reporting signal for SAT was observed with BNT162b2 and mRNA-1273 vaccines when compared to other viral vaccines (RORs 3.58 and 3.44, respectively).
- This association was not found when comparing COVID-19 vaccines to influenza vaccines.
Conclusions:
- Subacute thyroiditis is relatively more frequently reported with mRNA COVID-19 vaccines in EudraVigilance.
- The findings suggest a potential association between mRNA COVID-19 vaccines and SAT.
- Further well-designed observational studies are necessary to confirm these findings.
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