Table 2.
Overall Summary of Unsolicited Adverse Events for the Safety Population
| Parameters | NVX-CoV2373 (n = 7569) |
Placebo (n = 7569) |
||
|---|---|---|---|---|
| n (%) | N | n (%) | N | |
| Any AEs | 2075 (27.4) | 3134 | 1649 (21.8) | 2577 |
| Any severe AEs | 88 (1.2) | 114 | 87 (1.1) | 113 |
| Any treatment-related AEs | 880 (11.6) | 1145 | 369 (4.9) | 489 |
| Any severe, treatment-related AEs | 15 (0.2) | 17 | 5 (<0.1) | 5 |
| Any MAAEs | 355 (4.7) | 419 | 336 (4.4) | 402 |
| Any treatment-related MAAEs | 36 (0.5) | 46 | 17 (0.2) | 19 |
| Any serious AEs | 59 (0.8) | 75 | 61 (0.8) | 72 |
| Any AEs leading to vaccination discontinuation | 23 (0.3) | 29 | 28 (0.4) | 50 |
| Any treatment-related AEs leading to vaccination discontinuation | 7 (<0.1) | 11 | 8 (0.1) | 9 |
| Any AEs leading to study discontinuation | 18 (0.2) | 18 | 13 (0.2) | 13 |
| Any treatment-related AEs leading to study discontinuation | 3 (<0.1) | 3 | 1 (<0.1) | 1 |
| Any potential immune-mediated medical conditions | 6 (<0.1) | 6 | 9 (0.1) | 9 |
| Any adverse event of special interest relevant to coronavirus disease 2019 | 12 (0.2) | 18 | 35 (0.5) | 51 |
All counts exclude reactogenicity AEs (selected preferred terms). Unsolicited AEs were classified as severe, medically attended, serious, leading to vaccination or study discontinuation, potential immune-mediated medical conditions, or adverse event of special interest.
Abbreviations: AE, adverse event; MAAE, medically attended adverse event.