Authors' objectives: To determine whether there is any evidence to support the (causal) association between receiving (any) COVID-19 vaccine and developing or having a relapse on systemic lupus erythematosus (SLE).

Authors' results and conclusions: Overall, there were 29 primary studies appraised and summarized in this systematic review. Of the 29 studies appraised in this systematic review, 17 studies were in the form of case reports (level of evidence 4) reporting on the exacerbation or new onset of SLE. Evidence provided from these case reports show heterogeneity in the distribution of age, sex, type of vaccine, duration since vaccination, frequency of previous vaccination, type and severity of flare, previous history of treatment, body part involved in the development of LE, signs and symptoms of the patients, diagnostic criteria employed in establishing flare or new onset, history of previous COVID--19 infection, as well as the outcome of these episodes. None of these case report provided any underlying population data; hence it is not possible to calculate the morbidity rate of LE post-COVID-19 vaccination of any type. These case reports provided some evidence on the temporality between exposure (c.q. COVID-19 vaccination) and the development of event (relapse or new-onset of LE). However, heterogeneity on the diagnostic criteria employed in these studies need to be taken into account in interpreting these case reports. In our previous systematic review investigating the causal association on adverse event following immunization (AEFI), cq. COVID-19 vaccination, we stated that we followed the 2019 World Health Organization (WHO) procedure that provides evidence at individual as well as population level. At the population level the aim is to answer the question “Can the given vaccine cause a particular adverse event?” (i.e. “Can it?”). This population level causality assessments are done through epidemiological studies and follow the criteria as proposed by Sir Bradford Hill criteria of causality. The individual level causal investigation aim is to address the question “Did the vaccine given to a particular individual cause the particular event reported?” (i.e. “Did it?”). In our present systematic review, investigating the developing or relapsing on SLE patient as causally associated AEFI post-COVID19 vaccination, we identified 17 case report (level of evidence 4), six small case series (level of evidence 4) on the exacerbation or new onset of SLE, five cross sectional study (level of evidence 4) of different sizes and one small case-control study (level of evidence 3). At the population level, although all of these studies provided evidence on temporality, none provide evidence on a dose-response relationship, nor provided consistent evidence on such association. The only study that may be able to provide data on the strength of the association in fact concluded that SARS-CoV2 vaccination did not significantly influence the medium-term subjective and objective disease activities or flares of SLE. As such, the present population level evidence does not provide enough proof of potential causal association on newly developed SLE or SLE flares as AEFI post-COVID-19 vaccination. The individual level assessment of the AEFI causal association depends on the assessment/data provided from the population level. At present, at best, there is no clear answer to the question at the population level; hence, there is an indeterminate conclusion at the individual level with regard to the AEFI causal association on SLE post- COVID-19 vaccination. At present, there is an indeterminate conclusion at the individual level with regard to the AEFI causal association of SLE postCOVID-19 vaccination.

Authors' methods: A comprehensive and systematic literature search was conducted on August 25, 2025. The search was done on commercial medical literature databases where a combination of key words was employed in this search. No limitation, such as on the language or date of publication, was implemented in any of these searches. A manual search, on the references of the articles that were retrieved in full, was conducted. Of the review, systematic or experts, articles that were identified and were retrieved in full all the relevant primary studies included in that review would be retrieved and the review article would not be discussed further.

Project Status: Completed

URL for project: https://www.worksafebc.com/en/about-us/research-services/evidence-based-medicine-and-systematic-reviews

Year Published: 2025

URL for published report: https://www.worksafebc.com/en/resources/health-care-providers/guides/covid-19-vaccine-systemic-lupus-erythematosus?lang=en&origin=s&returnurl=https%3A%2F%2Fwww.worksafebc.com%2Fen%2Fforms-resources%23sort%3DDate%26q%3DCOVID-19%2520Vaccine%2520and%2520Systemic%2520Lupus%2520Erythematosus%2520(SLE)%26f%3Alanguage-facet%3D%5BEnglish%5D%26tags%3DHealth%2520Care%2520Provider%7C13468b0b3f074f6bade3f57ac3cdfb8e%2CSystematic%2520Review%7Cf78c29d570c14ec3b5a394385905df70&highlight=COVID-19%20Vaccine%20and%20Systemic%20Lupus%20Erythematosus%20(SLE)

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Canada

Organisation Name: WorkSafeBC

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