COVID-19 Vaccines Appear to Be Well-Tolerated Among Patients With Systemic Lupus Erythematosus

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The primary objective of the VACOLUP study was to assess the tolerance of COVID-19 vaccines, including risk for incident flares, in patients with systemic lupus erythematosus.

COVID-19 vaccination was found to be well-tolerated in patients with systemic lupus erythematosus (SLE) and associated with a minimal risk for disease flares, if any, according to study results published in Lancet Rheumatology.

There are limited data on the safety of COVID-19 vaccines in patients with rheumatic diseases, such as SLE.

The current study (vaccination against COVID in systemic lupus [VACOLUP]) was aimed at determining the tolerance and safety of COVID-19 vaccines in patients with SLE. The primary outcome of the study was the occurrence of side effects, including flares.

The cross-sectional study included a 43-question web-based survey conducted between March and May 2021. A total of 696 patients with SLE (96% women; median age, 42 years) from 30 countries were eligible for participation. The Pfizer-BioNTech vaccine was the most common vaccine (57%), followed by Sinovac (22%), AstraZeneca (10%), and Moderna (8%). All patients received at least 1 dose of vaccine and approximately half of patients received a second dose.

A total of 45% (n=316) of patients developed side effects after the first vaccine dose, and this rate increased to 53% (n=181) after the second dose. In the majority of cases (83%), the symptoms were of minor or moderate intensity. Risk for side effects after the second dose was higher among patients who reported vs did not report side effects after the first dose (81% vs 35%, respectively; relative risk [RR], 2.30; 95% CI, 1.88-2.82; P <.0001).

Lupus flare was reported in 21 patients (3%), along with predominant musculoskeletal symptoms (90%) and fatigue (86%). Although the risk for disease flare was higher among patients with a history of lupus flare during the previous 12 months (RR, 5.52; 95% CI, 2.17-14.03; P <.001), there was no association between medications used for lupus or disease manifestations and the risk for side effects.

A significant finding of the study was that side effects after COVID-19 vaccination were common (approximately 50%); however, they did not impair daily functioning in the majority of patients with SLE.

The study had several limitations, including the use of self-reported data and subjective outcomes, and the absence of a control group.

“[T]he VACOLUP study suggests that COVID-19 vaccination appears well tolerated in patients with SLE, with only a minimal risk [for] flare, if any, including after the mRNA vaccines,” the study authors concluded. They added, “Willingness to get vaccinated against COVID-19 in patients with autoimmune diseases is limited by the fear of side effects and the paucity of available data. Therefore, disseminating these reassuring data might prove crucial to increasing vaccine coverage in patients with SLE.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Felten R, Kawka L, Dubois M, et al. Tolerance of COVID-19 vaccination in patients with systemic lupus erythematosus: the international VACOLUP study. Lancet Rheumatol. Published online July 21, 2021. doi:10.1016/S2665-9913(21)00221-6