Abstract 167: COVID-19 vaccine side effects in Type 1 diabetes mellitus patients as compared to healthy controls: Results from the COVAD study

Background: COVID-19 vaccinations have been proven to be generally safe in healthy populations. However, the data on the vaccine safety in patients with Type 1 Diabetes Mellitus (T1DM) is inadequate. The study aimed to evaluate the frequency and severity of the adverse vaccination effects (ADEs) and their risk factors among T1DM patients. Methods: This study analyzed data from the COVID-19 vaccination in Autoimmune Diseases (COVAD) survey database (May-Dec 2021; 110 collaborators, 94 countries), comparing COVID-19 vaccine adverse drug events among T1DM patients and healthy controls (HCs). The study was designed to assess post-COVID-19 vaccination ADE in patients with autoimmune diseases. Descriptive and comparative analysis was performed based on data distribution and variable types. Results: We included 5480 completed responses in this study. Of all responses, 5408 were HCs, and 72 were T1DM patients (43 females, 48.0% Caucasians). The majority of the respondents had received Pfizer vaccines (p < 0.001). 4052/5480 (73.9%) respondents had received 2 vaccine doses, rest had received 1 vaccine dose. The most common ADE reported was injection site pain (50.0%), with T1DM patients reporting significantly lower frequency of injection site pain than HCs [OR 0.6 (0.3-0.9), p = 0.045]. Multivariate analysis showed that T1DM respondents had higher frequency of severe skin rashes [OR = 8.0 (1.7-36.0), p = 0.007] than HCs. However, overall ADEs, major ADEs, minor ADE and hospitalization frequency remained similar between T1DM and HCs. Conclusions: COVID-19 vaccination was largely safe and well tolerated in patients with T1DM with similar ADE profile compared to HCs, except for increased frequency of skin rashes in them.