Table 1.
Performance of a disproportionality analysis in VigiBase, summarizing the reports on de novo or relapsing GN following COVID-19 vaccination with either viral-vectored or mRNA vaccines
| Variable |
ChAdOx1 nCOV-19 (AZ/UoO) |
NRVV Ad26 JNJ 78436735 |
Elasomeran Moderna mRNA |
Tozinameran Pfizer/BioNTech mRNA |
Full database |
||||
|---|---|---|---|---|---|---|---|---|---|
| Total no. of ICSRs available |
561,214 |
73,208 |
286,467 |
770,304 |
6,052,767 |
||||
| No. of ICSRs and statics by nephrotic syndrome and various glomerulonephritis | Cases | IC/IC025 | Cases | IC/IC025 | Cases | IC/IC025 | Cases | IC/IC025 | Cases |
| Nephrotic syndrome | 22 | –1.14/–1.80 | 6 | –0.08/–1.46 | 12 | –1.03/–1.96 | 103 | 0.60/0.31 | 530a |
| MPGN | 1 | –0.18/–3.98 | 0 | NA | 0 | NA | 0 | NA | 13 |
| FSGS | 3 | –1.21/–3.26 | 0 | NA | 0 | NA | 0 | NA | 13 |
| GN, minimal lesion | 7 | –0.96/–2.22 | 1 | –0.64/–4.43 | 2 | –1.62/–4.21 | 36 | 0.88/0.37 | 152b |
| RPGN | 1 | –2.90/–6.70 | 0 | NA | 3 | –0.77/–2.82 | 6 | –1.23/–2.60 | 116 |
| C3 glomerulonephritis | 1 | –0.18/–3.98 | 1 | 1.19/–2.60 | 0 | NA | 1 | –0.52/–4.32 | 13 |
| IgA nephropathy | 5 | –1.23/–2.75 | 0 | NA | 19 | 1.51/0.79 | 15 | –0.17/–1.00 | 134c |
| Anti-GBM disease | 1 | –0.46/–4.26 | 1 | 1.09/–2.70 | 1 | 0.20/–3.59 | 4 | 0.76/–0.98 | 17 |
| GN, proliferative | 0 | NA | 1 | 1.22/–2.58 | 0 | NA | 0 | NA | 12 |
| MGN | 0 | NA | 0 | NA | 3 | –0.32/–2.37 | 5 | –1.23/–2.60 | 82 |
| Glomerulonephritis, unspecified | 2 | –2.64/–5.23 | 1 | –0.72/–4.52 | 10 | 0.35/–0.67 | 21 | 0.01/–0.66 | 116 |
AZ, AstraZeneca; CI, confidence interval; COVID-19, coronavirus disease 2019; FSGS, focal segmental glomerulosclerosis; GBM, glomerular basement membrane; GN, glomerulonephritis; IC, information component; IC025, 95% credibility interval lower end point of IC; ICSR, individual case safety report; JNJ, Johnson & Johnson; MGN, membranous glomerulonephritis; MPGN, membranoproliferative glomerulonephritis; NA, not applicable; OR, odds ratio; RPGN, rapid-progressive glomerulonephritis; UoO, University of Oxford.
Values are n, unless otherwise indicated. IC and IC025 are given. A positive IC025 value (>0) is the traditional threshold used for statistical signal detection (in bold). For significant signals, reporting OR and its 95% CI are given (95% CIs were also calculated using the entire database from January 1, 2020, to August 18, 2021, as a comparator).
The OR of BNT162b2 (tozinameran) related nephrotic syndrome is 1.65 (95% CI, 1.33–2.05).
The OR of BNT162b2 (tozinameran) related minimal GN is 2.13 (95% CI, 1.46–3.09).
The OR of mRNA-1273 (elasomeran) related IgA nephropathy is 3.33 (95% CI, 2.05–5.40).