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Volume 9
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10.3390/vaccines9070730
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Article

Preliminary Data on Post Market Safety Profiles of COVID 19 Vaccines in Rheumatic Diseases: Assessments on Various Vaccines in Use, Different Rheumatic Disease Subtypes, and Immunosuppressive Therapies: A Two-Centers Study

by
Cinzia Rotondo
1,*,
Francesco Paolo Cantatore
1,
Marco Fornaro
2,
Ripalta Colia
1,
Giuseppe Busto
1,
Valeria Rella
1,
Stefania Sciacca
1,
Lucia Lops
1,
Daniela Cici
1,
Nicola Maruotti
1,
Francesca D’Onofrio
1,
Florenzo Iannone
2 and
Addolorata Corrado
1
1
Rheumatology Unit, Department of Medical and Surgical Sciences, Ospedali Riuniti di Foggia, Viale Luigi Pinto 1, 71122 Foggia, Italy
2
Rheumatology Unit, Department of Emergency and Organ Transplantations, Policlinico, Piazza G. Cesare 11, 70124 Bari, Italy
*
Author to whom correspondence should be addressed.
Vaccines 2021, 9(7), 730; https://doi.org/10.3390/vaccines9070730
Submission received: 26 April 2021 / Revised: 20 June 2021 / Accepted: 24 June 2021 / Published: 2 July 2021
(This article belongs to the Section Clinical Immunology)
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Abstract

An increased risk of developing severe infections has been evidenced in rheumatic disease (RD) patients, and anti-COVID-19 vaccination is strictly recommended for RD patients. However, up to now, no data are available on safety, immunogenicity and efficacy of COVID-19 vaccinations in RD patients. The possible development of adverse events (AEs), including the flare-up of underlying RD, represents a matter of growing importance. The aim of our study is to assess, in RD patients, the safety profile of different types of approved vaccines and the possible influence of immunosuppressive therapies and clinical or demographic characteristics of RD patients on development of AEs. Participants (n = 185; 30.7%) received anti-COVID-19 vaccinations, 137 with autoimmune/chronic inflammatory RD (Au/cIn-RD) and 48 with nonautoimmune/chronic inflammatory RD (no-Au/cIn-RD). AEs were recorded in 42% of patients after the first dose of vaccine, and in 26% of patients after the second dose. The most common reported AEs after anti-COVID 19 vaccines were site injection pain (17%), headache (12%), fever (12%), myalgia (10%) and fatigue (10%). Relapses of the underlying Au/c-In-RD were recorded in 2.2% of patients after the first dose of vaccine. In Au/c-In-RD the risk of developing AEs after the first dose of vaccine was lower in older patients (OR = 0.95; p = 0.001), and in the group of patients with complete control of RD (OR: 0.2; p = 0.010). A lower percentage of AEs was observed in patients with complete control of their Au/cIn-RD (29%) compared to those with low (57%) or moderate-high disease activity (63%) (p = 0.002 and p = 0.006 respectively). In this study all types of COVID-19 vaccines in use in Italy seemed safe in RD patients. The results of this study might provide reassuring information for Au/cIn RD patients and clinicians and could strengthen the data on vaccine safety to guide the use of COVID-19 vaccines in Au/cIn-RD on immunosuppressive agents.
Keywords: rheumatic diseases; relapse; flare; disease activity; DMARDs; biologic drugs; safety; efficacy; anti-COVID-19 vaccine; comirnaty; vaxzevria; SARs-COV-2 rheumatic diseases; relapse; flare; disease activity; DMARDs; biologic drugs; safety; efficacy; anti-COVID-19 vaccine; comirnaty; vaxzevria; SARs-COV-2

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MDPI and ACS Style

Rotondo, C.; Cantatore, F.P.; Fornaro, M.; Colia, R.; Busto, G.; Rella, V.; Sciacca, S.; Lops, L.; Cici, D.; Maruotti, N.; et al. Preliminary Data on Post Market Safety Profiles of COVID 19 Vaccines in Rheumatic Diseases: Assessments on Various Vaccines in Use, Different Rheumatic Disease Subtypes, and Immunosuppressive Therapies: A Two-Centers Study. Vaccines 2021, 9, 730. https://doi.org/10.3390/vaccines9070730

AMA Style

Rotondo C, Cantatore FP, Fornaro M, Colia R, Busto G, Rella V, Sciacca S, Lops L, Cici D, Maruotti N, et al. Preliminary Data on Post Market Safety Profiles of COVID 19 Vaccines in Rheumatic Diseases: Assessments on Various Vaccines in Use, Different Rheumatic Disease Subtypes, and Immunosuppressive Therapies: A Two-Centers Study. Vaccines. 2021; 9(7):730. https://doi.org/10.3390/vaccines9070730

Chicago/Turabian Style

Rotondo, Cinzia, Francesco Paolo Cantatore, Marco Fornaro, Ripalta Colia, Giuseppe Busto, Valeria Rella, Stefania Sciacca, Lucia Lops, Daniela Cici, Nicola Maruotti, and et al. 2021. "Preliminary Data on Post Market Safety Profiles of COVID 19 Vaccines in Rheumatic Diseases: Assessments on Various Vaccines in Use, Different Rheumatic Disease Subtypes, and Immunosuppressive Therapies: A Two-Centers Study" Vaccines 9, no. 7: 730. https://doi.org/10.3390/vaccines9070730

APA Style

Rotondo, C., Cantatore, F. P., Fornaro, M., Colia, R., Busto, G., Rella, V., Sciacca, S., Lops, L., Cici, D., Maruotti, N., D’Onofrio, F., Iannone, F., & Corrado, A. (2021). Preliminary Data on Post Market Safety Profiles of COVID 19 Vaccines in Rheumatic Diseases: Assessments on Various Vaccines in Use, Different Rheumatic Disease Subtypes, and Immunosuppressive Therapies: A Two-Centers Study. Vaccines, 9(7), 730. https://doi.org/10.3390/vaccines9070730

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