Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study

Abstract

IntroductionVaccination represents a cornerstone in mastering the COVID-19 pandemic. Data on immunogenicity and safety of messenger RNA (mRNA) vaccines in patients with autoimmune inflammatory rheumatic diseases (AIIRD) are limited.MethodsA multicentre observational study evaluated the immunogenicity and safety of the two-dose regimen BNT162b2 mRNA vaccine in adult patients with AIIRD (n=686) compared with the general population (n=121). Serum IgG antibody levels against SARS-CoV-2 spike S1/S2 proteins were measured 2–6 weeks after the second vaccine dose. Seropositivity was defined as IgG ≥15 binding antibody units (BAU)/mL. Vaccination efficacy, safety, and disease activity were assessed within 6 weeks after the second vaccine dose.ResultsFollowing vaccination, the seropositivity rate and S1/S2 IgG levels were significantly lower among patients with AIIRD versus controls (86% (n=590) vs 100%, p<0.0001 and 132.9±91.7 vs 218.6±82.06 BAU/mL, p<0.0001, respectively). Risk factors for reduced immunogenicity included older age and treatment with glucocorticoids, rituximab, mycophenolate mofetil (MMF), and abatacept. Rituximab was the main cause of a seronegative response (39% seropositivity). There were no postvaccination symptomatic cases of COVID-19 among patients with AIIRD and one mild case in the control group. Major adverse events in patients with AIIRD included death (n=2) several weeks after the second vaccine dose, non-disseminated herpes zoster (n=6), uveitis (n=2), and pericarditis (n=1). Postvaccination disease activity remained stable in the majority of patients.ConclusionmRNA BNTb262 vaccine was immunogenic in the majority of patients with AIIRD, with an acceptable safety profile. Treatment with glucocorticoids, rituximab, MMF, and abatacept was associated with a significantly reduced BNT162b2-induced immunogenicity.

Effect of Immunosuppression on the Immunogenicity of mRNA Vaccines to SARS-CoV-2

“…Thus, our findings should be interpreted with caution and as hypothesis generating. Nevertheless, other groups have also reported that some patients with CID receiving immunosuppressants mounted reduced humoral responses compared with immunocompetent participants ( 18 , 19 , 29 ).…”

Single-Cell Profiling of the Antigen-Specific Response to BNT162b2 SARS-CoV-2 RNA Vaccine

“…The multi-compartment vaccine response induced by BNT162b2 may have important ramifications, particularly in immunocompromised populations. Reduced humoral responses have been reported to SARS-CoV-2 infection or BNT162b2 in patients with solid organ transplant (68)(69)(70), cancer (71), or immune-mediated inflammatory diseases (72,73). The identification of altered proteins or specific cell populations to serve as biomarkers for successful vaccination may provide important insight to monitor development and continued protection of these vulnerable populations.…”

Tolerance of COVID-19 vaccination in patients with systemic lupus erythematosus: the international VACOLUP study

“…Another limitation is the absence of a control group. However, Furer and colleagues 8 reported that the prevalence of mild adverse events was similar in patients with autoimmune rheumatic and musculoskeletal disease and controls.…”