BNT162b2 mRNA COVID-19 vaccine and booster in patients with autoimmune rheumatic diseases: a national cohort study

Abstract

IntroductionEmerging evidence supports the immunogenic response to mRNA COVID-19 vaccine in patients with autoimmune rheumatic diseases (ARD). However, large-scale data about the association between vaccination, and COVID-19 outcomes in patients with ARD is limited.MethodsWe used data from Clalit Health Services, which covers more than half of the population in Israel. Patients with ARD older than 18 were included between 20 December 2021 and 30 September 2021, when the BNT162b2 mRNA COVID-19 vaccine, and later a third booster dose, were available. The primary outcome was a documented positive SARS-CoV-2 PCR test. We used a Cox regression models with vaccination status as time-dependent covariate and calculated the HR for the study outcome.ResultsWe included 127 928 patients with ARD, of whom, by the end of the study follow-up, there were 27 350 (21.3%) unvaccinated patients, 31 407 (24.5%) vaccinated patients and 69 171 (54.1%) patients who also received a third booster-dose. We identified 8470 (6.6%) patients with a positive SARS-CoV-2 PCR test during the study period. The HR for SARS-CoV-2 infection among the vaccination group was 0.143 (0.095 to 0.214, p<0.001), and among the booster group was 0.017 (0.009 to 0.035, p<0.001). Similar results were found regardless of the type of ARD group or antirheumatic therapy.ConclusionOur results indicate that both the BNT162b2 mRNA COVID-19 vaccine and the booster are associated with better COVID-19 outcomes in patients with ARD.

Absent or suboptimal response to booster dose of COVID-19 vaccine in patients with autoimmune systemic diseases

“…The widest analysis so far performed is an Israeli national cohort study on 127,928 ASD patients reporting that people receiving mRNA COVID-19 vaccine and, particularly, the booster dose, had a better COVID-19 outcome. This finding might indirectly suggest an effective vaccine-driven immune protection [ 27 ].…”

COVID-19 vaccine immunogenicity in 16 patients with autoimmune systemic diseases. Lack of both humoral and cellular response to booster dose and ongoing disease modifying therapies

“…The available literature showed that vaccination is the major tool to control and fight the COVID-19 pandemic; this is particularly true for frail patients’ populations [ 28 ] such as individuals with ASD. Several reports highlighted that ASD patients have a significantly higher prevalence of COVID-19 compared to general population [ 29 ] as well as that 3-dose vaccinated ASD subjects, compared to unvaccinated or 2-dose vaccinated patients, are more protected from severe COVID-19 consequences [ 30 ]. Nevertheless, even after the booster dose, a subgroup of ASD patients still maintains an impaired/absent humoral response, mainly (but not exclusively), due to concomitant DMT [ 5 , 13 , 14 ].…”

Interplay of diabetes mellitus and rheumatic diseases amidst the COVID-19 pandemic: influence on the risk of infection, outcomes, and immune responses

“…A study in India reported that post-vaccination antibody titers are the most important determinant for breakthrough infections [58]. On the other hand, many comorbidities were associated with breakthrough infections in Israel, but DM was not a significant factor [59].…”