Summary of findings table for ChAdOxl COVID-19 vaccine in people with autoimmune rheumatic diseases.†
| Outcomes | Anticipated Absolute Effects* (95% CI) | Relative Effect (95% CI) | No. of Participants (Studies) | Certainty of the Evidence, GRAD | |
|---|---|---|---|---|---|
| Risk with MenACWY/Placebo | Risk with ChAdOx1 SD/SD COVID-19 vaccine | ||||
| Mortality | 33 per 100,000 | 17 fewer per 100,000 | RR 0.49 | 24,244 | ⊕◯◯◯ |
| (30 fewer to 56 more) | (0.09–2.66) | (1 RCT) | VERY LOWa,b | ||
| Severe or critical disease | 9 per 100,000 | 6 fewer per 100,000 | RR 0.33 | 23,745 | ⊕◯◯◯ |
| (8 fewer to 60 more) | (0.01–7.98) | (1 RCT) | VERY LOWa,b | ||
| Incidence of symptomatic COVID-19 confirmed with positive test | 2890 per 100,000 | 1,937 fewer per 100,000 | RR 0.33 | 17,177 | ⊕⊕⊕◯ |
| (2226–1648 fewer) | (0.23–0.43) | (1 RCT) | MODERATEa | ||
| Severe adverse events | 1062 per 100,000 | 180 fewer per 100,000 | RR 0.83 | 24,244 | ⊕◯◯◯ |
| (382 fewer to 74 more) | (0.64–1.07) | (1 RCT) | VERY LOWc,d | ||
| Autoimmune adverse events | There were 3 cases of transverse myelitis (2 in the vaccine group, 1 in the placebo). It is not clear enough in the reporting if there were other potentially autoimmune adverse events. | (0 RCTs) | ⊕◯◯◯ | ||
| VERY LOWc,e | |||||
| Incidence of any adverse events | 1053 per 100,000 | 274 fewer per 100,000 | RR 0.74 | 23,983 | ⊕⊕◯◯ |
| (463–42 fewer) | (0.56–0.96) | (1 RCT) | LOWc | ||
| Exacerbation of preexisting disease | Immunization did not generally cause clinically significant worsening of underlying ARDs. A metaanalysis evaluating the effect of influenza and pneumococcal vaccination in SLE demonstrated that immunization had no significant effect on the SLEDAI score. | 759 | ⊕◯◯◯ | ||
| (20 observational studies) | VERY LOWd | ||||
GRADE Working Group grades of evidence: (1) high certainty: we are very confident that the true effect lies close to that of the estimate of the effect; (2) moderate certainty: we are moderately confident in the effect estimate (the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different); (3) low certainty: our confidence in the effect estimate is limited (the true effect may be substantially different from the estimate of the effect); (4) very low certainty: we have very little confidence in the effect estimate (the true effect is likely to be substantially different from the estimate of effect).
↵†Interactive table available online at https://gdt.gradepro.org/presentations/#/isof/isof_94981a15–9190–45fb-8198–75c95cbd5328–1620580107344?_k=dlzkfe.
↵*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
↵aDowngraded 1 level because autoimmune patients were excluded from the trials.
↵bImprecision downgraded by 2 levels due to wide CI consistent with the possibility for benefit and the possibility for harm and few events.
↵cDowngraded 2 levels for indirectness because autoimmune patients were excluded from the trials and the control groups mixed a placebo and an active component (meningitis vaccine).
↵dImprecision downgraded by 1 level due to wide CI consistent with the possibility for no effect and the possibility for benefit.
↵eImprecision downgraded by 2 levels due to scarcity of data and insufficient reporting. ARD: autoimmune rheumatic disease; COVID-19: coronavirus disease 2019; GRADE: Grading of Recommendations Assessment, Development, and Evaluation; MenACWY: meningococcal vaccine; RR: risk ratio; RCT: randomized controlled trial; SD/SD: standard dose; SLE: systemic lupus erythematosus; SLEDAI: SLE Disease Activity Index.