A retrospective cohort study: vaccination status and safety analysis of SARS-CoV-2 vaccine in patients with Wilson's disease
Authors: Han Hui , Zhao Dan , Fang Xinru , Yang Wenming , Wang Mengli , Liu Qianzhuo , Wang Luyao , Ji Zhihui , Zhang Juan , Hou Zhifeng , Hua Lei , Wang Yu , Wu Limin 
Published: December 2022

Abstract
Background

Wilson's disease (WD) is a rare hepatic and neurological disorder that tends to worsen slowly. However, traumatic injuries, surgeries, and severe infections can dramatically worsen the disease. No studies have reported whether SARS-CoV-2 vaccination affects disease progression in patients with WD. Vaccination decisions in this population are affected by the potential adverse events following vaccination. This study aimed to determine SARS-CoV-2 vaccination status and post-vaccination adverse events in patients with WD. To assess the correlation between vaccination status and Unified Wilson's Disease Rating Scale (UWDRS) scores.

Methods

This was a multicenter, retrospective, observational cohort study. Data on patient characteristics, current vaccination status, vaccine type, vaccine dose, and adverse events of the vaccine were collected. We evaluated the vaccination rates in various regions of China. Subjective reasons for non-vaccination were analyzed. To compare the baseline data between the two groups, age, male, liver cirrhosis, hypersplenism, post-splenectomy, kidney damage, bone damage, and cholecystitis were used as confounding factors to compare the differences between the vaccinated and unvaccinated groups. Differences in UWDRS scores between vaccinated and unvaccinated patients were analyzed using independent-sample t-tests. Paired sample t-tests were used to analyze whether there were differences in UWDRS scores before and after vaccination in vaccinated patients. Logistic regression analysis was used to assess the correlation between vaccination status and increased UWDRS scores.

Results

Among the 554 patients with WD included in the study, the mean age was 25.3±10.85 years. A total of 368 (66.4%) patients received at least one dose of the SARS-CoV-2 vaccine (1 dose, n=10; 2 doses, n=161; 3 doses, n=197). A total of 186 patients (33.6%) were unvaccinated. The subjective reasons why patients did not receive the vaccine were advice from the medical center (n=83,44.6%), fear of worsening WD symptoms (n=63, 33.9%), and doubts about the effectiveness and safety of the vaccine (n=40, 21.5%). There was no significant difference in confounding factors between the vaccinated and unvaccinated groups (P>0.05). This indicated that the baseline data of the two groups maintained a certain balance. Multifactorial regression analysis showed no correlation between the confounding factors and vaccination status. There was no statistically significant difference in the UWDRS scores between the two groups (P>0.05). There was no statistically significant difference in the UWDRS scores before and after vaccination (P>0.05). Logistic regression analysis showed that vaccination against SARS-CoV-2 was not significantly associated with increased scores on the UWDRS (OR=0.924, 95% CI:0.336-2.540, P=0.879), hepatic subscale (OR=0.170, 95% CI:0.148-3.027, P=0.603), neurological subscale (OR=1.322, 95% CI:0.219-7.984, P=0.761), and psychiatric subscale (OR=1.011, 95% CI:0.183-5.571, P=0.990). A total of 78 (21.2%) of the 368 patients who received at least one dose of the vaccine had adverse events. Eight patients (2.2%) showed worsening symptoms of extrapyramidal damage. Local and systemic adverse reactions occurred in 70 (19.0 %) patients, 48 (13.0%) had local pain at the injection site, 6 (1.6%) had swelling of the vaccination arm, 6 (1.6%) had fever, 4 (1.1%) had headache, 3 (0.8%) had weakness, 2 (0.5%) had stomach ache, and 1 (0.3%) had palpitations.

Conclusion

In this cohort study, vaccination against SARS-CoV-2 was safe in patients with WD, providing evidence for the safety of vaccination in patients with WD. It also provides a reference for patients with other heavy metal metabolism disorders, nervous system damage, and similar diseases to be vaccinated against SARS-CoV-2.