Summary of findings table for BNT 162b2 and mRNA-1273 (mRNA) COVID-19 vaccines in people with autoimmune rheumatic diseases.†
| Outcomes | Anticipated Absolute Effects* (95% CI) | Relative Effect (95% CI) | No. of Participants (Studies) | Certainty of the Evidence, GRADE | |
|---|---|---|---|---|---|
| Risk With Placebo | Risk With COVID-19 Vaccine | ||||
| Mortality | 30 per 100,000 | 22 per 100,000 (9–54) | RR 0.73 (0.29–1.81) | 73,603 (2 RCTs) | ⊕⊕◯◯ LOWa,b |
| Severe or critical disease | 110 per 100,000 | 4 per 100,000 | RR 0.04 | 70,780 | ⊕⊕⊕◯ |
| (1–21) | (0.01–0.19) | (2 RCTs) | MODERATEa | ||
| Incidence of symptomatic COVID-19 confirmed with positive test | 1099 per 100,000 | 55 per 100,000 | RR 0.05 | 63,129 | ⊕⊕⊕◯ |
| (33–99) | (0.03–0.09) | (2 RCTs) | MODERATEa | ||
| Severe adverse events | 717 per 100,000 | 739 per 100,000 | RR 1.03 | 73,603 | ⊕⊕◯◯ |
| (624–875) | (0.87–1.22) | (2 RCTs) | LOWa,b | ||
| Autoimmune adverse events | 13 per 100,000 | 7 per 100,000 | RR 0.50 | 30,351 | ⊕◯◯◯ |
| (1–73) | (0.05–5.51) | (1 RCT) | VERY LOWa,b | ||
| Incidence of any adverse events | 16,075 per 100,000 | 25559 per 100,000 | RR 1.59 | 73,603 | ⊕⊕◯◯ |
| (24,755–26,362) | (1.54–1.64) | (2 RCTs) | LOWa,c | ||
| 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 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 https://gdt.gradepro.org/presentations/#/isof/isof_d4a3bbe1–0a4f-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.