August 12, 2021

In two recent studies, researchers found that the four COVID-19 vaccines are well-tolerated in lupus patients.

Given that the Moderna and Pfizer vaccines are the first mRNA vaccines currently authorized for the emergency use in people, lupus researchers have since worked to answer questions specifically about potential side effects and whether these might trigger flares in patients with lupus.

In one international study conducted in 30 countries around the globe and published in the highly respected journal Lancet, researchers followed 696 patients with systemic lupus erythematosus (SLE) who received at least one dose of the Pfizer, Moderna, Sinovac or AstraZeneca vaccines. Although all four vaccines require two doses, only 343 patients received a second dose within the timeframe of the study.

Results showed that side effects after receiving a dose were mild to moderate and did not impact their daily activities. For the 3% of SLE patients who did experience a flare, this was linked to having had a flare within the last year, before receiving the vaccine. Given the low frequency of flares, as well as the patients’ recent history of another flare, this suggests they may not be necessarily linked to vaccinations.

Furthermore, there did not appear to be much difference in the severity of side effects between lupus patients who received an mRNA vaccine versus those who received another type of vaccine. This includes patients who received the Sinovac or AstraZeneca vaccines, both of which are adenovirus-based. Adenovirus vaccines are made using a virus that has been altered so that it can no longer make a person sick or replicate within the body.

Published in the official journal of the American College of Rheumatology, Arthritis and Rheumatology, the second study reports on 1377 patients with rheumatic and musculoskeletal disease, 20% of whom were lupus patients. Patients completed questionnaires about their symptoms within one week and after one month of receiving their first and second doses of an mRNA vaccine.

Researchers found that patients who received two doses of an mRNA COVID-19 vaccine did not experience severe flares or other side effects that required hospitalization, and their quality of life and normal activities were not significantly impacted after receiving a dose. This finding helps allay questions about if the side effects from the second vaccine dose might be significantly more severe than after the first.

Of the 11% of patients who did experience a flare after receiving a dose, these flares were typically associated with prior COVID-19 infection, having experienced a flare within the last six months, as well as in some instances with receiving the therapy managing their autoimmune disease. Importantly, none of these flares were significant enough to warrant hospitalization.

Given the questions about what side effects lupus patients may experience after getting vaccinated for COVID-19, as well as the lack of lupus patients in early COVID-19 vaccine trials, these new studies provide additional data showing that the vaccines are well tolerated and safe in lupus patients and linked to flares in only a small number of patients with this disease. Results of these two studies are reassuring not only for patients with lupus but also for people with other autoimmune diseases and can help reduce hesitancy about the COVID-19 vaccines, which have thus far demonstrated to effectively reduce the occurrence of severe disease and hospitalization in general population.

Click here for the Lancet paper.

Click here for the Arthritis and Rheumatology paper.