Immunogenicity of SARS-CoV-2 BNT162b2 Vaccine in People with Diabetes: A Prospective Observational Study

The mRNA-based BNT162b2 vaccine has demonstrated high efficacy against severe SARS-CoV-2. However, data regarding immune response in people with diabetes mellitus (DM) after vaccination with the BNT162b2 vaccine are limited. In this prospective observational study, we examined humoral immune response in participants with and without DM after vaccination with the BNT162b2 mRNA vaccine. A total of 174 participants (58 with and 116 without diabetes, matched for age) were included. Antibodies were measured 21 days after the first dose, 7-15 days after the second dose, and 70-75 days after the second and before the third dose of the vaccine. Antibodies were measured by an anti-SARS-CoV-2 receptor-binding domain IgG (Abs-RBD-IgG) assay by a chemiluminescent microparticle immune assay; values > 50 AU/mL are considered protective from severe disease. Almost 17% of participants with DM did not develop adequate humoral immune response to the BNT162b2 mRNA vaccine after the first dose; however, it was high and similar after the second dose in both participants with and without DM and remained so almost 2 months after the second dose of the vaccine. Geometric mean values of Abs-RBD-IgG were not significantly different between participants with and without DM during the study. At least two doses of the BNT162b2 vaccine are necessary to ensure adequate and sustainable immune response in people with DM.

Automated summary

The mRNA-based BNT162b2 vaccine showed high efficacy against severe SARS-CoV-2 infection. Limited data is available regarding the immune response in people with diabetes after vaccination with the BNT162b2 vaccine. This study found that almost 17% of participants with diabetes did not develop adequate immune response after the first dose, but the response became high and similar between participants with and without diabetes after the second dose, and remained stable even two months after the second dose. There was no significant difference in antibody levels between participants with and without diabetes throughout the study. At least two doses of the BNT162b2 vaccine are required for sufficient and sustainable immune response in people with diabetes.