Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jul 5;62(7):2453-2463.
doi: 10.1093/rheumatology/keac661.

Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus: results from the COVAD study

R Naveen  1 , Elena Nikiphorou  2   3 , Mrudula Joshi  4 , Parikshit Sen  5 , Julius Lindblom  6 , Vishwesh Agarwal  7 , James B Lilleker  8   9 , Ai Lyn Tan  10   11 , Babur Salim  12 , Nelly Ziade  13   14 , Tsvetelina Velikova  15 , Abraham Edgar Gracia-Ramos  16 , Masataka Kuwana  17 , Jessica Day  18   19   20 , Ashima Makol  21 , Oliver Distler  22 , Hector Chinoy  8   23   24 , Lisa S Traboco  25 , Suryo Anggoro Kusumo Wibowo  26 , Erick Adrian Zamora Tehozol  27 , Jorge Rojas Serrano  28 , Ignacio García-De La Torre  29 ; COVAD Study Group; Rohit Aggarwal  30 , Latika Gupta  1   8   31   32 , Vikas Agarwal  1 , Ioannis Parodis  6   33
Collaborators, Affiliations

Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus: results from the COVAD study

R Naveen et al. Rheumatology (Oxford). .

Abstract

Objective: To determine COVID-19 vaccine-related adverse events (AEs) in the seven-day post-vaccination period in patients with SLE vs autoimmune rheumatic diseases (AIRDs), non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HC).

Methods: Data were captured through the COVID-19 Vaccination in Autoimmune Diseases (COVAD) questionnaire (March-December 2021). Multivariable regression models accounted for age, gender, ethnicity, vaccine type and background treatment.

Results: Among 9462 complete respondents, 583 (6.2%) were SLE patients (mean age: 40.1 years; 94.5% females; 40.5% Asian; 42.9% Pfizer-recipients). Minor AEs were reported by 83.0% of SLE patients, major by 2.6%, hospitalization by 0.2%. AE and hospitalization frequencies were similar between patients with active and inactive SLE. Rashes were more frequent in SLE patients vs HC (OR; 95% CI: 1.2; 1.0, 1.5), chills less frequent in SLE vs AIRDs (0.6; 0.4, 0.8) and nrAIDs (0.5; 0.3, 0.8), and fatigue less frequent in SLE vs nrAIDs (0.6; 0.4, 0.9). Pfizer-recipients reported higher overall AE (2.2; 1.1, 4.2) and injection site pain (2.9; 1.6, 5.0) frequencies than recipients of other vaccines, Oxford/AstraZeneca-recipients more body ache, fever, chills (OR: 2.5, 3.0), Moderna-recipients more body ache, fever, chills, rashes (OR: 2.6, 4.3). Hospitalization frequencies were similar across vaccine types. AE frequencies were similar across treatment groups, although chills were less frequent in antimalarial users vs non-users (0.5; 0.3, 0.9).

Conclusion: While COVID-19 vaccination-related AEs were reported by four-fifths of SLE patients, those were mostly minor and comparable to AEs reported by healthy individuals, providing reassurance regarding COVID-19 vaccination safety in SLE.

Keywords: COVID-19; adverse events; rheumatology; systemic lupus erythematosus; vaccine.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Flow diagram of patients included in the study. *An electronic protocol terminated the survey automatically if respondents indicated not having received any COVID-19 vaccine. AIRDs: autoimmune rheumatic diseases (excluding SLE and IIM); HC: healthy controls; IIM: idiopathic inflammatory myositis; nrAIDs: non-rheumatic autoimmune diseases; SLE: systemic lupus erythematosus
Figure 2.
Figure 2.
Selected vaccination-related AEs in patients with SLE. The forest plot illustrates selected results from multivariable logistic regression analysis. Circles denote odds ratios (ORs) and whiskers denote 95% confidence intervals. AEs: adverse events; LoS: level of significance; SLE: systemic lupus erythematosus
Figure 3.
Figure 3.
Frequencies of vaccination-related adverse events (AEs) across patients with various rheumatic diseases and healthy controls. AEs: adverse events; AIRDs: autoimmune rheumatic diseases (excluding SLE and IIM); HC: healthy controls; nrAIDs: non-rheumatic autoimmune diseases
See this image and copyright information in PMC

References

    1. Chen L, Cai X, Zhao T. et al. Safety of global SARS-CoV-2 vaccines, a meta-analysis. vaccines. Vaccines 2022;10:596. - PMC - PubMed
    1. Grainger R, Kim AHJ, Conway R, Yazdany J, Robinson PC.. COVID-19 in people with rheumatic diseases: risks, outcomes, treatment considerations. Nat Rev Rheumatol 2022;18:191–204. - PMC - PubMed
    1. Tavares A, de Melo AKG, Cruz VA. et al. Guidelines on COVID-19 vaccination in patients with immune-mediated rheumatic diseases: a Brazilian Society of Rheumatology task force. Adv Rheumatol 2022;62:3. - PMC - PubMed
    1. Funck-Brentano C, Nguyen LS, Salem JE.. Retraction and republication: cardiac toxicity of hydroxychloroquine in COVID-19. Lancet 2020;396:e2–3. - PMC - PubMed
    1. Tleyjeh IM, Kashour Z, AlDosary O. et al. Cardiac toxicity of chloroquine or hydroxychloroquine in patients with COVID-19: a systematic review and meta-regression analysis. Mayo Clin Proc Innov Qual Outcomes 2021;5:137–50. - PMC - PubMed

Publication types