Table 4.

Summary of findings table for ChAdOxl COVID-19 vaccine in people with autoimmune rheumatic diseases.

OutcomesAnticipated Absolute Effects* (95% CI)Relative Effect (95% CI)No. of Participants (Studies)Certainty of the Evidence, GRAD
Risk with MenACWY/PlaceboRisk with ChAdOx1 SD/SD COVID-19 vaccine
Mortality33 per 100,00017 fewer per 100,000RR 0.4924,244⊕◯◯◯
(30 fewer to 56 more)(0.09–2.66)(1 RCT)VERY LOWa,b
Severe or critical disease9 per 100,0006 fewer per 100,000RR 0.3323,745⊕◯◯◯
(8 fewer to 60 more)(0.01–7.98)(1 RCT)VERY LOWa,b
Incidence of symptomatic COVID-19 confirmed with positive test2890 per 100,0001,937 fewer per 100,000RR 0.3317,177⊕⊕⊕◯
(2226–1648 fewer)(0.23–0.43)(1 RCT)MODERATEa
Severe adverse events1062 per 100,000180 fewer per 100,000RR 0.8324,244⊕◯◯◯
(382 fewer to 74 more)(0.64–1.07)(1 RCT)VERY LOWc,d
Autoimmune adverse eventsThere 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)⊕◯◯◯
Incidence of any adverse events1053 per 100,000274 fewer per 100,000RR 0.7423,983⊕⊕◯◯
(463–42 fewer)(0.56–0.96)(1 RCT)LOWc
Exacerbation of preexisting diseaseImmunization 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–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.