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Article

Immune-Mediated Disease Flares or New-Onset Disease in 27 Subjects Following mRNA/DNA SARS-CoV-2 Vaccination

1
Department of Medicine ‘B, Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer 10457, Israel
2
Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 69978, Israel
3
Rheumatology Unit, Sheba Medical Center, Tel-Hashomer 10457, Israel
4
NIHR, Leeds Biomedical Research Centre, The Leeds Teaching Hospitals NHS Trust & Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds LS9 7TF, UK
5
Gastroenterology Department, Sheba Medical Center, Tel-Aviv 10457, Israel
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Department of Neurology, Sheba Medical Center, Tel-Aviv 10457, Israel
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Rheumatology Unit, Carmel Medical Center, Michal Street, Haifa 3436212, Israel
8
Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa 3200003, Israel
9
Department of Rheumatology, Galilee Medical Center, Azrieli Faculty of Medicine, Bar-Ilan University, Safed 22100, Israel
10
Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Tel Aviv 10457, Israel
11
Department of Rheumatology, Mid Yorkshire Hospitals, West Yorkshire WF8 1PL, UK
12
Centre for Disease Modelling, Department of Mathematics and Statistics, York University, Toronto, ON M3J 1P3, Canada
13
Fields-CQAM Laboratory of Mathematics for Public Health (MfPH), York University, Toronto, ON M3J 1P3, Canada
14
Cleveland Clinic Foundation, 9500 Euclid Avenue, Desk A50, Cleveland, OH 44195, USA
*
Authors to whom correspondence should be addressed.
These authors contributed equally to this study.
Academic Editor: Eduardo Gomez-Casado
Vaccines 2021, 9(5), 435; https://doi.org/10.3390/vaccines9050435
Received: 14 March 2021 / Revised: 14 April 2021 / Accepted: 23 April 2021 / Published: 29 April 2021
(This article belongs to the Section Vaccine Adjuvants)
Background: Infectious diseases and vaccines can occasionally cause new-onset or flare of immune-mediated diseases (IMDs). The adjuvanticity of the available SARS-CoV-2 vaccines is based on either TLR-7/8 or TLR-9 agonism, which is distinct from previous vaccines and is a common pathogenic mechanism in IMDs. Methods: We evaluated IMD flares or new disease onset within 28-days of SARS-CoV-2 vaccination at five large tertiary centres in countries with early vaccination adoption, three in Israel, one in UK, and one in USA. We assessed the pattern of disease expression in terms of autoimmune, autoinflammatory, or mixed disease phenotype and organ system affected. We also evaluated outcomes. Findings: 27 cases included 17 flares and 10 new onset IMDs. 23/27 received the BNT - 162b2 vaccine, 2/27 the mRNA-1273 and 2/27 the ChAdOx1 vaccines. The mean age was 54.4 ± 19.2 years and 55% of cases were female. Among the 27 cases, 21 (78%) had at least one underlying autoimmune/rheumatic disease prior the vaccination. Among those patients with a flare or activation, four episodes occurred after receiving the second-dose and in one patient they occurred both after the first and the second-dose. In those patients with a new onset disease, two occurred after the second-dose and in one patient occurred both after the first (new onset) and second-dose (flare). For either dose, IMDs occurred on average 4 days later. Of the cases, 20/27 (75%) were mild to moderate in severity. Over 80% of cases had excellent resolution of inflammatory features, mostly with the use of corticosteroid therapy. Other immune-mediated conditions included idiopathic pericarditis (n = 2), neurosarcoidosis with small fiber neuropathy (n = 1), demyelination (n = 1), and myasthenia gravis (n = 2). In 22 cases (81.5%), the insurgence of Adverse event following immunization (AEFI)/IMD could not be explained based on the drug received by the patient. In 23 cases (85.2%), AEFI development could not be explained based on the underlying disease/co-morbidities. Only in one case (3.7%), the timing window of the insurgence of the side effect was considered not compatible with the time from vaccine to flare. Interpretation: Despite the high population exposure in the regions served by these centers, IMDs flares or onset temporally-associated with SARS-CoV-2 vaccination appear rare. Most are moderate in severity and responsive to therapy although some severe flares occurred. Funding: none. View Full-Text
Keywords: vaccine safety; COVID-19; mRNA-based vaccine; adenoviral vector-based vaccine; immune-mediated diseases vaccine safety; COVID-19; mRNA-based vaccine; adenoviral vector-based vaccine; immune-mediated diseases
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MDPI and ACS Style

Watad, A.; De Marco, G.; Mahajna, H.; Druyan, A.; Eltity, M.; Hijazi, N.; Haddad, A.; Elias, M.; Zisman, D.; Naffaa, M.E.; Brodavka, M.; Cohen, Y.; Abu-Much, A.; Abu Elhija, M.; Bridgewood, C.; Langevitz, P.; McLorinan, J.; Bragazzi, N.L.; Marzo-Ortega, H.; Lidar, M.; Calabrese, C.; Calabrese, L.; Vital, E.; Shoenfeld, Y.; Amital, H.; McGonagle, D. Immune-Mediated Disease Flares or New-Onset Disease in 27 Subjects Following mRNA/DNA SARS-CoV-2 Vaccination. Vaccines 2021, 9, 435. https://doi.org/10.3390/vaccines9050435

AMA Style

Watad A, De Marco G, Mahajna H, Druyan A, Eltity M, Hijazi N, Haddad A, Elias M, Zisman D, Naffaa ME, Brodavka M, Cohen Y, Abu-Much A, Abu Elhija M, Bridgewood C, Langevitz P, McLorinan J, Bragazzi NL, Marzo-Ortega H, Lidar M, Calabrese C, Calabrese L, Vital E, Shoenfeld Y, Amital H, McGonagle D. Immune-Mediated Disease Flares or New-Onset Disease in 27 Subjects Following mRNA/DNA SARS-CoV-2 Vaccination. Vaccines. 2021; 9(5):435. https://doi.org/10.3390/vaccines9050435

Chicago/Turabian Style

Watad, Abdulla, Gabriele De Marco, Hussein Mahajna, Amit Druyan, Mailam Eltity, Nizar Hijazi, Amir Haddad, Muna Elias, Devy Zisman, Mohammad E. Naffaa, Michal Brodavka, Yael Cohen, Arsalan Abu-Much, Muhanad Abu Elhija, Charlie Bridgewood, Pnina Langevitz, Joanna McLorinan, Nicola L. Bragazzi, Helena Marzo-Ortega, Merav Lidar, Cassandra Calabrese, Leonard Calabrese, Edward Vital, Yehuda Shoenfeld, Howard Amital, and Dennis McGonagle. 2021. "Immune-Mediated Disease Flares or New-Onset Disease in 27 Subjects Following mRNA/DNA SARS-CoV-2 Vaccination" Vaccines 9, no. 5: 435. https://doi.org/10.3390/vaccines9050435

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