Interstitial lung disease following COVID-19 vaccination: A disproportionality analysis using the Global Scale Pharmacovigilance Database (VigiBase)open access
- Authors
- Lee, Min-Taek; Lee, Ju Won; Lee, Hyeon Ji; Lee, Jong-Min; Choi, Jae Chol; Gu, Kang-Mo; Jung, Sun-Young
- Issue Date
- Dec-2023
- Publisher
- BMJ Publishing Group
- Keywords
- COVID-19; drug induced lung disease
- Citation
- BMJ Open Respiratory Research, v.10, no.1
- Journal Title
- BMJ Open Respiratory Research
- Volume
- 10
- Number
- 1
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/69371
- DOI
- 10.1136/bmjresp-2023-001992
- ISSN
- 2052-4439
2052-4439
- Abstract
- Background and objective Despite several case reports, population-based studies on interstitial lung disease (ILD) following COVID-19 vaccination are lacking. Given the unprecedented safety issue of COVID-19 vaccination, it is important to assess the worldwide patterns of ILD following COVID-19 vaccination. This study aimed to investigate the signals of COVID-19 vaccine-associated ILD compared with other vaccinations using disproportionality analysis. Methods We analysed the VigiBase database during the period between 13 December 2020 and 26 January 2023. We adopted the case/non-case approach to assess the disproportionality signal of ILD for COVID-19 vaccines via 1:10 matching by age and sex. We compared COVID-19 vaccines with all other vaccines as the reference group. Results Among 1 233 969 vaccine-related reports, 679 were reported for ILD. The majority of ILD cases were related to tozinameran (376 reports, 55.4%), Vaxzevria (129 reports, 19.0%) and elasomeran (78 reports, 11.5%). The reporting OR of ILD following COVID-19 vaccination was 0.86 (95% CI 0.64 to 1.15) compared with all other vaccines. Conclusion No significant signal of disproportionate reporting of ILD was observed for COVID-19 vaccines compared with all other vaccines. Moreover, when compared with the influenza vaccines that are known to cause ILD, no signal was observed. This study results might help decision-making on the subsequent COVID-19 vaccination strategy of ILD. Further large and prospective studies are required for more conclusive evidence. © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
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