Table 3.

Summary of findings table for Ad26.COV2.S 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, GRADE
Risk With PlaceboRisk With Ad26.COV2.S COVID-19 Vaccine
Mortality91 per 100,00069 fewer per 100,000RR 0.2543,783⊕⊕◯◯
(83–30 fewer)(0.09–0.67)(1 RCT)LOWa,b
Severe or critical disease409 per 100,000311 fewer per 100,000RR 0.2439,058⊕⊕⊕◯
(352–250 fewer)(0.14–0.39)(1 RCT)MODERATEa
Incidence of symptomatic COVID-19 confirmed with positive test1796 per 100,0001,203 fewer per 100,000RR 0.3339,058⊕⊕⊕◯
(1311–1060 fewer)(0.27 to 0.41)(1 RCT)MODERATEa
Severe adverse events439 per 100,00061 fewer per 100,000RR 0.8643,783⊕⊕◯◯
(158 fewer to 70 more)(0.64–1.16)(1 RCT)LOWa,c
Autoimmune adverse events“There were single reports of Guillain-Barre Syndrome (GBS) in a 60-year-old vaccine recipient and a 75-year-old placebo recipient occurring on Days 16 and 10, respectively. The event in the vaccine group was preceded by symptoms of chills, nausea, diarrhea and myalgia. In FDA’s assessment the events of [...] GBS are unlikely related to study vaccine but a causal relationship cannot be definitively excluded.”40(0 RCT)⊕◯◯◯
Incidence of any adverse events19,438 per 100,00030,712 more per 100,000RR 2.586736⊕⊕⊕◯
(27,019–34,794 more)(2.39–2.79)(1 RCT)MODERATEa
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–4903-b704–3df58e02dfa7–1620580142011?_k=t82vzx.

  • *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 for indirectness as autoimmune patients were not included in the trials.

  • bDowngraded 1 level for imprecision due to small number of events.

  • cDowngraded 1 level for imprecision due to CI including serious benefits and serious harms.

  • dImprecision 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; RR: risk ratio; RCT: randomized controlled trial; SLE: systemic lupus erythematosus; SLEDAI: SLE Disease Activity Index.