Background/Purpose: SLE patients are an especially vulnerable population in the face of the COVID pandemic due to their dysregulated endogenous immune system, further downregulated by their disease-controlling immunosuppressant medication. The currently available mRNA SARS-CoV-2 vaccines were not studied in this population, given that immunosuppression was an exclusion criterion in their phase 3 clinical trials evaluating safety and efficacy (1, 2). We evaluated the self-reported effects of mRNA SARS-CoV-2 vaccines in SLE patients, as well as infection.

Methods: We studied SLE cohort patients who were followed with standardized annual assessments at a Canadian tertiary care centre. From January 2021 to May 2022, 345 SLE patients consecutively seen for their annual research visit reported information on SARS-CoV-2 vaccinations. We performed descriptive data analysis on the type of vaccination received, side effects as well as ER visits and hospitalizations (up to the time of their last assessment).

Results: The patients were mostly female (n=306, 88.7%) and Caucasian (n=209, 60.6 %) and the average SLE duration was 19.7 years (SD 11.9). 298 patients (86.4%) had received at least one SARS-CoV-2 vaccination and 248 (71.9%) has received at least 2 doses. Specifically, 50 (14.5%) had received one dose, 150 (43.5%) had received 2 doses and 98 (28.4%) had received at least 3. Most (n=181, 60.7%) of initial doses were Pfizer, followed by Moderna (n=54, 18.1%), AstraZeneca (n=12, 4.0%) and Johnson & Johnson (n=1, 0.3%). The remaining (n=50, 16.8%) were unknown. 159 (63.3%) of the second doses were Pfizer, and 49 (19.5%) were Moderna.

Among those who have received at least 1 vaccination dose, 34 of 128 patients who responded to the question reported symptoms post-vaccine (26.6%). The most common symptoms were fever and injection-related arm pain; both were reported at equal frequency (n=9, 7.0%). This is followed by fatigue and headache (n=6, 4.6% for both). There were 3 cases of myalgia and 2 cases of arthralgia. One patient reported hypertension after the first dose of vaccine, which required an ER visit. The remaining did not specify their symptoms. No patients reported disease flare in the post-vaccination period.

Amongst those who provided information about SARS-CoV-2 infection (n=243, 70.4%), 19.3% reported testing positive for SARS-CoV-2, and the remaining (80.7%) never tested positive for COVID. Only one patient required hospitalization for SARS-CoV-2 infection and was vaccine naïve at the time.

Conclusion: SARS-CoV-2 mRNA vaccine side effects in this SLE population occurred in about a quarter, but most were mild, similar to the general population. SARS-CoV-2 vaccine did not induce any side effects requiring hospitalization. Since, in our cohort, the one patient requiring hospitalization for SARS-CoV-2 infection was vaccine naïve, a benefit for SARS-CoV-2 vaccination in SLE seems evident.

References
1. Polack FP et al., C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615.
2. Baden LR, et al; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416.

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