A retrospective cohort study: vaccination status and safety analysis of SARS-CoV-2 vaccine in patients with Wilson’s disease

ABSTRACT

Background

Wilson’s disease (WD) is a rare hepatic and neurological disorder, which can dramatically worsen by traumatic injuries, surgeries, and infections. No studies have reported safety data of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in WD patients. We aimed to investigate the SARS-CoV-2 vaccination status and post-vaccination adverse events in WD patients.

Methods

This is a multicenter, retrospective, observational study. We investigated the vaccination rates, the type of vaccine, subjective reasons for non-vaccination, and the adverse events following vaccination. Logistic regression analysis was used to assess the correlation between vaccination status and increased Unified Wilson’s Disease Rating Scale (UWDRS) scores.

Results

A total of 554 WD patients with a mean (SD) age of 25.3 (10.85) years were included in this study, of whom 336 (60.6%) were males and 218 (39.4%) were females. 368 (66.4%) patients received at least one dose of the SARS-CoV-2 vaccine.186 (33.6%) patients were unvaccinated. Logistic regression analysis showed that vaccination against SARS-CoV-2 was not significantly associated with increased UWDRS scores. The safety analysis demonstrated that 21.2% had post-vaccination adverse events.

Conclusions

In this study, vaccination against SARS-CoV-2 was safe in WD patients, providing evidence for the safety of vaccination in WD patients.

KEYWORDS:

• SARS-CoV-2
• vaccine
• Wilson’s disease
• UWDRS
• COVID-19

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Authors’ contributions

Hui Han and Limin Wu have full access to all data in the study and are responsible for the data’s integrity and the data analysis’s accuracy; Hui Han, Dan Zhao, and Xinru Fang contributed equally to this work. Hui Han, Dan Zhao, and Xinru Fang are the co-first authors; Conception and design: Hui Han, Limin Wu; Case collection: Dan Zhao, Xinru Fang, Mengli Wang, Zhihui Ji, Qianzhuo Liu, Luyao Wang, Juan Zhang, Zhifeng Hou, Lei Hua, Yu Wang; Data collection, data analysis, or interpretation: Dan Zhao, Xinru Fang, Wenming Yang, Mengli Wang, Zhihui Ji, Juan Zhang, Zhifeng Hou, Lei Hua, Yu Wang; Manuscript drafting: Dan Zhao, Xinru Fang; Critical revision of the manuscript for important intellectual content: Hui Han,Limin Wu; Statistical analysis: Dan Zhao, Xinru Fang; Obtaining funding: Hui Han,Limin Wu; Administrative, technical, or material support: Hui Han,Limin Wu; Supervision: Limin Wu. All authors read and approved the final manuscript.

Acknowledgments

This manuscript has been stored on the preprint server and is available at the website (https://www.researchsquare.com/article/rs-2152063/latest).

Ethics approval and consent to participate

All patient identifiers were removed from the database, and no personal identifiers were used during the study. This study was conducted in accordance with the guidelines of the Declaration of Helsinki. This study was approved by the Medical Ethics Committee of the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine (No. 2021MCZQ07).

Availability of data and materials

The datasets used or analyzed during the current study are available from the corresponding author on reasonable request.

Additional information

Funding

This manuscript was funded by the National Natural Science Foundation of China (Grants No. 82374212, 81971446, 81673811, 81373671, and 81473534) and Clinical Translational Special Project, Anhui Provincial Science and Technology Department, China (No. 202204295107020044).