Table 5. Sensitivity Analysis: Observed to Expected Analysis of Guillain-Barré Syndrome After the Ad26.COV2.S COVID-19 Vaccine, Assuming That 80% of Cases Are Ultimately Confirmed Based on Brighton Collaboration Criteria8.
| Age groups, y | No.a | Vaccine doses administeredb | Person-yearsb | Background rate per 100 000 person-years | Expected cases | Rate ratio (95% CI) |
|---|---|---|---|---|---|---|
| Onset within 21 days after vaccination | ||||||
| All (≥18) | 84 | 13 209 858 | 751 904 | 1.51 | 11.4 | 7.40 (5.90-9.16) |
| All (≥18) | 84 | 13 209 858 | 751 904 | 2 | 15.0 | 5.59 (4.46-6.92) |
| 18-<65 | 73 | 11 169 018 | 635 740 | 1.22 | 7.8 | 9.41 (7.38-11.83) |
| 18-<65 | 73 | 11 169 018 | 635 740 | 2 | 12.7 | 5.74 (4.50-7.22) |
| 18-29 | 2 | 2 388 973 | 135 980 | 0.88 | 1.2 | 1.67 (0.20-6.04) |
| 30-39 | 8 | 2 277 609 | 129 641 | 1.07 | 1.4 | 5.77 (2.49-11.36) |
| 40-49 | 18 | 2 345 471 | 133 504 | 1.29 | 1.7 | 10.45 (6.19-16.52) |
| 50-64 | 45 | 4 156 965 | 236 614 | 1.63 | 3.9 | 11.67 (8.51-15.61) |
| 50-64 | 45 | 4 156 965 | 236 614 | 2 | 4.7 | 9.51 (6.94-12.72) |
| ≥65 | 11 | 2 040 840 | 116 164 | 2.34 | 2.7 | 4.05 (2.02-7.24) |
| ≥65 | 11 | 2 040 840 | 116 164 | 2.4 | 2.8 | 3.95 (1.97-7.06) |
| Onset within 42 days after vaccination | ||||||
| All (≥18) | 98 | 13 209 858 | 1 472 162 | 1.51 | 22.2 | 4.41 (3.58-5.37) |
| All (≥18) | 98 | 13 209 858 | 1 472 162 | 2 | 29.4 | 3.33 (2.70-4.06) |
| 18-<65 | 84 | 11 169 018 | 1 244 722 | 1.22 | 15.2 | 5.53 (4.41-6.85) |
| 18-<65 | 84 | 11 169 018 | 1 244 722 | 2 | 24.9 | 3.37 (2.69-4.18) |
| 18-29 | 3 | 2 388 973 | 266 237 | 0.88 | 2.3 | 1.28 (0.26-3.74) |
| 30-39 | 10 | 2 277 609 | 253 826 | 1.07 | 2.7 | 3.68 (1.77-6.77) |
| 40-49 | 20 | 2 345 471 | 261 389 | 1.29 | 3.4 | 5.93 (3.62-9.16) |
| 50-64 | 51 | 4 156 965 | 463 270 | 1.63 | 7.6 | 6.75 (5.03-8.88) |
| 50-64 | 51 | 4 156 965 | 463 270 | 2 | 9.3 | 5.50 (4.10-7.24) |
| ≥65 | 14 | 2 040 840 | 227 440 | 2.34 | 5.3 | 2.63 (1.44-4.41) |
| ≥65 | 14 | 2 040 840 | 227 440 | 2.4 | 5.5 | 2.56 (1.40-4.30) |
a
Reports with missing age, missing onset, or onset more than 42 days are not included in these calculations. One report had missing age, sex, and onset information, but was still deemed a valid report of Guillain-Barré syndrome. For 6 people, the onset time was more than 42 days: 62, 70, 75, 85, 89, or 94 days after vaccination.
b
Cumulative Vaccine Administration Data.9 Please see the Methods section. Age-specific dose administration data were obtained from the Centers for Disease Control and Prevention and are shown with permission (F. Lee, MPH, statistician, Centers for Disease Control and Prevention, email September 3, 2021).