COVID-19 Vaccine Effectiveness and Risk Factors of Booster Failure in 480,000 Patients with Diabetes Mellitus: A Population-Based Cohort Study.

To investigate the real-world effectiveness of COVID-19 vaccines in a large cohort of patients with diabetes mellitus (DM), we analyzed all >18-year-old patients with COVID-19 registered in a Brazilian nationwide surveillance database between February 2020 and February 2023. The primary outcome of interest was vaccine effectiveness against death, evaluated using multivariate logistic regression models. Among the 2,131,089 patients registered in the SIVEP-Gripe, 482,677 (22.6%) had DM. After adjusting for covariates, patients with DM had a higher risk of death than those without comorbidities (adjusted odds ratio [aOR] = 1.43, 95% CI, 1.39-1.47). For patients without comorbidities (72.7%, 95% CI, 70.5-74.7) and those with DM (73.4%, 95% CI, 68.2-76.7), vaccine effectiveness was similar after the booster dose. However, it was reduced in patients with DM associated with other comorbidities (60.5%; 95% CI, 57.5-63.2). The strongest factor associated with booster failure was the omicron variant (aOR = 27.8, 95% CI, 19.9-40.1). Our study revealed that COVID-19 vaccines provided robust protection against death in individuals with DM. However, our findings underscore the need to update vaccines and develop tailored strategies for individuals with diabetes, especially those with additional underlying conditions.