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Immunogenicity and safety of SARS-CoV-2 mRNA vaccines in a cohort of patients with type 1 diabetes

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posted on 12.05.2022, 22:08 by Francesca D’Addio, Gianmarco Sabiu, Vera Usuelli, Emma Assi, Ahmed Abdelsalam, Anna Maestroni, Andy Joe Seelam, Moufida Ben Nasr, Cristian Loretelli, Davide Mileto, Giada Rossi, Ida Pastore, Laura Montefusco, Paola S. Morpurgo, Laura Plebani, Antonio Rossi, Enrica Chebat, Andrea M. Bolla, Elena Lunati, Chiara Mameli, Maddalena Macedoni, Spinello Antinori, Stefano Rusconi, Maurizio Gallieni, Cesare Berra, Franco Folli, Massimo Galli, Maria Rita Gismondo, Gian Vincenzo Zuccotti, Paolo Fiorina

Patients with type 1 diabetes (T1D) may develop severe outcomes during COVID-19 disease, but their ability to generate an immune response against the SARS-CoV-2 messenger RNA (mRNA) vaccines remains to be established. Here we evaluated the safety, immunogenicity and glycometabolic effects of the SARS-CoV-2 mRNA vaccines in patients with T1D. A total of 375 patients, 326 with T1D and 49 non-diabetics, who received two doses of the SARS-CoV-2 mRNA vaccines (mRNA-1273, BNT162b2) between March and April 2021 at the ASST FBF-Sacco Milan, Italy, were included in this monocentric observational study (NCT04905823). Local and systemic adverse events were reported in both groups after SARS-CoV-2 mRNA vaccination without statistical differences between them. While both T1D patients and non-diabetic subjects exhibited a parallel increase in anti-SARS-CoV-2S titers after vaccination, the vast majority of T1D patients (70% and 78% respectively) did not show any increase in the SARS-CoV-2-specific cytotoxic response as compared to the robust increase observed in all non-diabetic subjects. A reduced secretion of the T cell-related cytokines IL-2 and TNF-alpha in vaccinated patients with T1D was also observed. No glycometabolic alterations were evident in patients with T1D using continuous glucose monitoring during follow-up. Administration of the SARS-CoV-2 mRNA vaccine is associated with an impaired cellular SARS-CoV-2-specific cytotoxic immune response in T1D patients.  


F.D. is supported by an SID Lombardia Grant and by an EFSD/JDRF/Lilly Programme on Type 1 Diabetes Research 2019. P.F. is supported by the Italian Ministry of Health grant RF-2016-02362512 and by the Linea-2 2019 funding from Università di Milano.