Table 4.
Sensitivity analysis of incidence rates per 1000 person years and incidence rate ratios of developing thrombosis with thrombocytopenia syndrome or venous or arterial thromboembolic events in the 28 days after use of adenovirus versus mRNA based covid-19 vaccination in analyses passing diagnostics
| Sensitivity analysis and medical records database | Target comparator combination | Event | No of individuals after propensity score matching | No of person years | No of events | Incidence rates (95% CI)/1000 person years | Calibrated incidence rate ratio (95% CI) |
|---|---|---|---|---|---|---|---|
| Thrombocytopenia window to five days before/after thrombosis after vaccination | |||||||
| UK CPRD |
First dose BNT162b2 (comparator) | Any thrombosis (venous thromboembolism or arterial thromboembolism) with thrombocytopenia syndrome | 1 934 829 | 95 580 | 63 | 0.66 (0.51 to 0.84) | Reference |
| First dose ChAdOx1-S (target) | 1 934 829 | 143 963 | 120 | 0.83 (0.69 to 1) | 1.3 (0.95 to 1.79) | ||
| Second dose BNT162b2 (comparator) | 1 076 870 | 64 286 | 38 | 0.59 (0.42 to 0.81) | Reference | ||
| Second dose ChAdOx1-S (target) | 795 723 | 41 085 | 37 | 0.9 (0.63 to 1.24) | 1.23 (0.74 to 2.04) | ||
| US Open Claims |
First dose BNT162b2 (comparator) | 2 365 342 | 172 785 | 376 | 2.18 (1.96 to 2.41) | Reference | |
| First dose Ad26.COV2.S (target) | 628 592 | 47 020 | 143 | 3.04 (2.56 to 3.58) | 1.09 (0.66 to 1.81)* | ||
| First dose mRNA-1273 (comparator) | 2 232 627 | 169 867 | 378 | 2.23 (2.01 to 2.46) | Reference | ||
| Ad26.COV2.S (target) | 628 758 | 47 030 | 143 | 3.04 (2.56 to 3.58) | 0.96 (0.6 to 1.53)* | ||
| Thrombocytopenia threshold of <100 000 platelets per microlitre | |||||||
| US Open Claims |
First dose mRNA-1273 (comparator) | Deep vein thrombosis with thrombocytopenia syndrome | 2 271 774 | 172 851 | 12 | 0.07 (0.04 to 0.12) | Reference |
| Ad26.COV2.S (target) | 639 496 | 47 843 | 6 | 0.13 (0.05 to 0.27) | 1.35 (0.45 to 4.05)* | ||
| US Open Claims |
First dose BNT162b2 (comparator) | Venous thromboembolism with thrombocytopenia syndrome | 2 404 904 | 175 752 | 13 | 0.07 (0.04 to 0.13) | Reference |
| Ad26.COV2.S (target) | 639 269 | 47 828 | 11 | 0.23 (0.11 to 0.41) | 2.45 (0.95 to 6.29)* | ||
| First dose mRNA-1273 (comparator) | 2 271 552 | 172 835 | 14 | 0.08 (0.04 to 0.14) | Reference | ||
| Ad26.COV2.S (target) | 639 432 | 47 838 | 11 | 0.23 (0.11 to 0.41) | 1.92 (0.77 to 4.8)* | ||
| UK CPRD |
First dose BNT162b2 (comparator) | Any thrombosis (venous thromboembolism or arterial thromboembolism) with thrombocytopenia syndrome | 1 263 960 | 95 597 | 63 | 0.66 (0.51 to 0.84) | Reference |
| First dose ChAdOx1-S (target) | 1 935 138 | 143 986 | 119 | 0.83 (0.68 to 0.99) | 1.29 (0.94 to 1.78) | ||
| Second dose BNT162b2 (comparator) | 1 077 077 | 64 299 | 39 | 0.61 (0.43 to 0.83) | Reference | ||
| Second dose ChAdOx1-S (target) | 795 893 | 41 094 | 37 | 0.9 (0.63 to 1.24) | 1.25 (0.76 to 2.06) | ||
| US Open Claims |
First dose BNT162b2 (comparator) | 2 365 254 | 172 778 | 378 | 2.19 (1.97 to 2.42) | Reference | |
| Ad26.COV2.S (target) | 628 571 | 47 019 | 146 | 3.11 (2.62 to 3.65) | 1.11 (0.67 to 1.84)* | ||
| First dose mRNA-1273 (comparator) | 2 232 550 | 169 861 | 380 | 2.24 (2.02 to 2.47) | Reference | ||
| Ad26.COV2.S (target) | 628 737 | 47 028 | 146 | 3.1 (2.62 to 3.65) | 0.97 (0.61 to 1.55)* | ||
UK CPRD=Clinical Practice Research Datalink Aurum.
*
Did not pass the systematic error diagnostics of >80% uncalibrated confidence intervals covering 1.