Table 2.
Summary of all adverse event types reported during the study (Day 0 to end of follow-up).
| Event, subject n (%) | NVX-CoV2373 | Placebo |
|---|---|---|
| Reactogenicity | N = 27,797 | N = 13,004 |
| Solicited injection site reaction within 7 days | 17,333 (76.03 %) | 3782 (29.08 %) |
| Dose 1/Dose 2 | 12,178 (53.42 %)/15,213 (66.73 %) | 2510 (19.30 %)/2241 (17.23 %) |
| Grade 3+ (any dose) | 1432 (6.28 %) | 62 (0.48 %) |
| Solicited systemic reaction within 7 days | 15,870 (69.61 %) | 6141 (47.22 %) |
| Dose 1/Dose 2 | 10,077 (44.20 %)/13,252 (58.13 %) | 4675 (35.95 %)/3767 (28.97 %) |
| Grade 3+ (any dose) | 2589 (11.36 %) | 465 (3.58 %) |
| Other AEs | N = 30,077 | N = 19,871 |
| Any unsolicited AEs | 6266 (20.83 %) | 3656 (18.40 %) |
| Non-serious unsolicited AE | 6102 (20.29 %) | 3539 (17.81 %) |
| Treatment-related nonserious unsolicited AEs | 2713 (9.02 %) | 924 (4.65 %) |
| Grade 3 non-serious unsolicited AE | 220 (0.73 %) | 109 (0.55 %) |
| Treatment-related Grade 3 non-serious unsolicited AE | 81 (0.27 %) | 17 (0.09 %) |
| Any SAEs | 275 (0.91 %) | 198 (1.00 %) |
| Treatment-related SAEs | 8 (0.03 %) | 4 (0.02 %) |
| MAAEs | 1598 (5.31 %) | 966 (4.86 %) |
| Treatment-related MAAEs | 146 (0.49 %) | 52 (0.26 %) |
| AEs leading to discontinuation | 82 (0.27 %) | 36 (0.18 %) |
| PIMMCs (CRF or SMQ) | 45 (0.15 %) | 31 (0.16 %) |
| Deaths | 21 (0.07 %) | 12 (0.06 %) |
AE = adverse event; CRF = case report form; MAAE = medically attended adverse event; PIMMC = potential immune-mediated medical condition; SAE = serious adverse event; SMQ = standardized MedDRA query.