Safety and Efficacy of SARS-CoV-2 mRNA Vaccines in Patients With Chronic Inflammatory Diseases Demonstrated

elderly man receiving COVID-19 vaccine wearing a mask
The immunogenicity and safety of SARS-CoV-2 mRNA vaccines in patients with chronic inflammatory conditions receiving immunosuppressive therapy were determined.

The mRNA vaccines against SARS-CoV-2 were found to be immunogenic, without considerable side effects or the induction of disease flares in patients with chronic inflammatory diseases (CIDs), according to study results published in Annals of the Rheumatic Diseases.

Limited data are available on the efficacy and safety of mRNA vaccines in patients receiving immunosuppressive therapies for CID. Therefore, the objective of the current study was to assess the safety and immunogenicity of the mRNA vaccines against SARS-CoV-2 in patients with CID compared with healthy individuals.

The study sample included 26 patients with CID (mean age, 50.5 years; 64.3% women) and 42 healthy control participants (mean age, 37.5 years; 69.2% women). Immunoglobulin (Ig) G antibodies against SARS-CoV-2 were quantified by enzyme-linked immunosorbent assay (ELISA) before initial vaccination and 7 days after secondary vaccination. Disease activity was assessed at baseline, 7 days after the first vaccination, on the day of the second immunization, and 7 days thereafter.

After the second vaccination, neutralizing antibodies and total anti-SARS-CoV-2 IgG were detected in all patients in both groups. None of the participants displayed considerable antibody titers before the first vaccination, indicating no prior infection.

Mean levels of specific immunoglobulin against the SARS-CoV-2 spike protein 7 days after the secondary immunization were significantly lower among patients with CID compared with control participants (2053 vs 2658 binding antibody units [BAU]/mL; P =.037). Similarly, mean specific IgA levels were lower among patients with CID than among control participants (24.52 vs 47.65 U/mol; P =.0035). However, these levels were above the ELISA cutoff in all patients.

Fatigue and myalgia were more frequent in the group of patients with CID compared with control participants (53.8% vs 43.2% and 42.3% vs 31.6%, respectively). However, arthralgia was comparable among both groups. No flares of the underlying inflammatory condition were observed in the context of the vaccination.

The study had several limitations, including the small sample size, potential impact of patient selection on the outcomes, and lack of data on long-term protection offered by vaccines.

“The data in this study indicate that mRNA vaccines against SARS-CoV-2 are immunogenic and safe in patients with [CID],” the researchers concluded.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.


Geisen UM, Berner DK, Tran F, et al. Immunogenicity and safety of anti-SARS-CoV-2 mRNA vaccines in patients with chronic inflammatory conditions and immunosuppressive therapy in a monocentric cohort. Published online March 24, 2021. Ann Rheum Dis. doi:10.1136/annrheumdis-2021-220272

This article originally appeared on Rheumatology Advisor