First Report of the Immunogenicity of an Inactivated SARS-CoV-2 (COVID-19) Vaccine in Iranian Patients with Autoimmune Diseases.

Background: Infectious diseases are responsible for considerable morbidity and mortality worldwide, and coronavirus disease 2019 (COVID-19) is one of these infections. Because of the substantial bur- den on the healthcare system, considerable efforts have been made to immunize the population against severe acute respiratory syndrome coronavirus 2 through vaccination. However, there are considerations regarding the efficacy of vaccines in autoimmune patients. The current study revealed the immunogenicity of inactivated COVID-19 vaccines among the Iranian population with rheumatic diseases. Methods: As the first report from Iran, in this descriptive cross-sectional study, 196 patients were sam- pled; 98 of whom had an autoimmune disease and 98 of whom served as controls. Blood samples were collected and tested with IgM and IgG ELISA kits for COVID-19 antibody (Ab) levels. Some demo- graphic characteristics were recorded. Results: This study revealed an Ab response after inactivated COVID-19 vaccination among 196 par- ticipants, including 98 healthy individuals and 98 autoimmune patients. Our analysis revealed that the case group had a profoundly lower percentage of IgG- and IgM-positive individuals, at 37.7% and 13.2%, respectively, than the control group, which had significantly greater percentages of IgG and IgM Abs, at 86.7% and 65.3%, respectively. Conclusion: Individuals with autoimmune conditions, especially women, presented considerable decreases in IgG levels after vaccination with the inactivated COVID-19 vaccine. It seems that those with autoimmune disorders may experience immune system fatigue, leading to lower Ab levels fol- lowing COVID-19 vaccination. Several potential factors, such as the use of immunosuppressive medi- cations, could explain the reduced Ab response after COVID-19 vaccination. As a result, individuals with compromised immune systems, including those with autoimmune disorders, should be closely monitored and prioritized for additional COVID-19 vaccine doses to improve protection. Furthermore, the possible effects of repeated vaccinations on immune exhaustion and reduced defense against microbial infections highlight the need for further research in this patient population. It can be con- cluded that special vaccine protocols for all kinds of vaccinations should be approved for patients with autoimmune diseases.