Table 2.

Summary of findings table for BNT 162b2 and mRNA-1273 (mRNA) COVID-19 vaccines 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 COVID-19 Vaccine
Mortality30 per 100,00022 per 100,000
RR 0.73
(2 RCTs)
Severe or critical disease110 per 100,0004 per 100,000RR 0.0470,780⊕⊕⊕◯
(1–21)(0.01–0.19)(2 RCTs)MODERATEa
Incidence of symptomatic COVID-19 confirmed with positive test1099 per 100,00055 per 100,000RR 0.0563,129⊕⊕⊕◯
(33–99)(0.03–0.09)(2 RCTs)MODERATEa
Severe adverse events717 per 100,000739 per 100,000RR 1.0373,603⊕⊕◯◯
(624–875)(0.87–1.22)(2 RCTs)LOWa,b
Autoimmune adverse events13 per 100,0007 per 100,000RR 0.5030,351⊕◯◯◯
(1–73)(0.05–5.51)(1 RCT)VERY LOWa,b
Incidence of any adverse events16,075 per 100,00025559 per 100,000RR 1.5973,603⊕⊕◯◯
(24,755–26,362)(1.54–1.64)(2 RCTs)LOWa,c
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 systemic 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–0a4f-42c8–93b3–8b71ce0a64f9–1620580039869?_k=z1jtm0.

  • *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 due to the population of interest being excluded from the trials.

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

  • cDowngraded 1 level for inconsistency due to extreme heterogeneity (chi-square = 513.92; df = 1 [P < 0.00001]); I2 = 100%.

  • dDowngraded 1 level for indirectness due to vaccine of interest not included in the studies. ARD: autoimmune rheumatic disease; COVID-19: coronavirus disease 2019; df: degrees of freedom; GRADE: Grading of Recommendations Assessment, Development, and Evaluation; RR: risk ratio; RCT: randomized controlled trial; SLE: systemic lupus erythematosus; SLEDAI: SLE Disease Activity Index.