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Volume 13
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10.3390/microorganisms13102266
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Article

Long-Term Safety of Anti-COVID-19 mRNA Vaccines in Patients with Systemic Lupus Erythematosus and Lupus-like Diseases with a Previous History of Myocarditis

by
Giovanni Benanti
1,
Marta Secci
1,2,
Andrea Villatore
3,4,
Sara Angiulli
1,3,
Chiara Calabrese
1,3,
Gabriele Domenico Gallina
1,
Veronica Batani
1,
Giacomo De Luca
1,3,
Corrado Campochiaro
1,3,
Giuseppe Pizzetti
5,
Giovanni Peretto
3,4,
Simone Sala
4,
Enrica P. Bozzolo
1,
Luca Moroni
1,3,
Marco Matucci-Cerinic
1,3,
Giuseppe A. Ramirez
1,3,* and
Lorenzo Dagna
1,3
1
Unit of Immunology, Rheumatology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132 Milan, Italy
2
Faculty of Medicine, University of Cagliari, Strada Provinciale 8, 09042 Monserrato, Italy
3
Faculty of Medicine, Vita-Salute San Raffaele University, Via Olgettina 58, 20132 Milan, Italy
4
Multidisciplinary Disease Unit for Myocarditis and Arrhythmogenic Cardiomyopathies, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132 Milan, Italy
5
Unit of Cardiology, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132 Milan, Italy
*
Author to whom correspondence should be addressed.
Microorganisms 2025, 13(10), 2266; https://doi.org/10.3390/microorganisms13102266
Submission received: 7 August 2025 / Revised: 15 September 2025 / Accepted: 24 September 2025 / Published: 26 September 2025
(This article belongs to the Special Issue SARS-CoV-2: Infection, Transmission, and Prevention)
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Abstract

Non-viral myocarditis is rare but relatively more frequent in patients with systemic autoimmune diseases (such as systemic lupus erythematosus, SLE, and allied conditions) than in the general population. In rare cases, mRNA-based vaccines can also trigger non-viral myocarditis. Limited data are available about the cardiac safety of mRNA vaccines in this subset of patients. Here, we report data from a third-level hospital on long-term safety, leveraging on a previously described cohort of 13 consecutive patients with SLE, Undifferentiated (UCTD) and Mixed Connective Tissue disease (MCTD), and a history of myocarditis, who had received anti-COVID-19 vaccination between April 2021 and January 2022. Demographics and clinical data (including validated clinometric for SLE) were collected at baseline, at the first available visit following the primary vaccination cycle, after an additional 12 months, and at the last available follow-up after at least 36 months. Twelve patients, seven females, ten with SLE, one MCTD, and one UCTD, had a median follow-up of 41 (35–45) months. One patient was lost at follow-up. No disease flare or sign of myocarditis recurrence were observed. At last visit, all patients were in a low disease activity state (LLDAS), and all but one were in remission, according to the Definition of Remission in SLE (DORIS) criteria. No significant variations in disease activity or damage accrual nor in markers of inflammation and myocardial injury were observed. Our data suggest that mRNA-based anti-COVID-19 vaccines in patients with previous autoimmune myocarditis in the context of SLE and allied conditions have a good long-term safety profile.
Keywords: anti SARS-CoV-2 vaccines; systemic lupus erythematosus; long term safety; myocarditis anti SARS-CoV-2 vaccines; systemic lupus erythematosus; long term safety; myocarditis

Share and Cite

MDPI and ACS Style

Benanti, G.; Secci, M.; Villatore, A.; Angiulli, S.; Calabrese, C.; Gallina, G.D.; Batani, V.; De Luca, G.; Campochiaro, C.; Pizzetti, G.; et al. Long-Term Safety of Anti-COVID-19 mRNA Vaccines in Patients with Systemic Lupus Erythematosus and Lupus-like Diseases with a Previous History of Myocarditis. Microorganisms 2025, 13, 2266. https://doi.org/10.3390/microorganisms13102266

AMA Style

Benanti G, Secci M, Villatore A, Angiulli S, Calabrese C, Gallina GD, Batani V, De Luca G, Campochiaro C, Pizzetti G, et al. Long-Term Safety of Anti-COVID-19 mRNA Vaccines in Patients with Systemic Lupus Erythematosus and Lupus-like Diseases with a Previous History of Myocarditis. Microorganisms. 2025; 13(10):2266. https://doi.org/10.3390/microorganisms13102266

Chicago/Turabian Style

Benanti, Giovanni, Marta Secci, Andrea Villatore, Sara Angiulli, Chiara Calabrese, Gabriele Domenico Gallina, Veronica Batani, Giacomo De Luca, Corrado Campochiaro, Giuseppe Pizzetti, and et al. 2025. "Long-Term Safety of Anti-COVID-19 mRNA Vaccines in Patients with Systemic Lupus Erythematosus and Lupus-like Diseases with a Previous History of Myocarditis" Microorganisms 13, no. 10: 2266. https://doi.org/10.3390/microorganisms13102266

APA Style

Benanti, G., Secci, M., Villatore, A., Angiulli, S., Calabrese, C., Gallina, G. D., Batani, V., De Luca, G., Campochiaro, C., Pizzetti, G., Peretto, G., Sala, S., Bozzolo, E. P., Moroni, L., Matucci-Cerinic, M., Ramirez, G. A., & Dagna, L. (2025). Long-Term Safety of Anti-COVID-19 mRNA Vaccines in Patients with Systemic Lupus Erythematosus and Lupus-like Diseases with a Previous History of Myocarditis. Microorganisms, 13(10), 2266. https://doi.org/10.3390/microorganisms13102266

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