Table 1.
Demographic and Clinical Characteristics by the Original Randomization Group Among Participants Who Received Crossover Doses and Had Follow-up in the Crossover Period
| Characteristic | Overall | NVX-CoV2373a | Placeboa |
|---|---|---|---|
| Did not crossover by 24 July 2021,b n | 7024 | 4033 | 2991 |
| Total N | 18 495 | 13 152 | 5343 |
| Country, n (%) | |||
| United States | 17 362 (93.9) | 12 354 (93.9) | 5008 (93.7) |
| Mexico | 1133 (6.1) | 798 (6.1) | 335 (6.3) |
| Median (range) age, y | 47 (18–95) | 47 (18–95) | 47 (18–90) |
| Age group, n (%) | |||
| 18–64 y | 16 335 (88.3) | 11 627 (88.4) | 4708 (88.1) |
| ≥65 y | 2160 (11.7) | 1525 (11.6) | 635 (11.9) |
| Sex, n (%) | |||
| Male | 9373 (50.7) | 6755 (51.4) | 2618 (49.0) |
| Female | 9122 (49.3) | 6397 (48.6) | 2725 (51.0) |
| Race or ethnic group, n (%) | |||
| White | 13 970 (75.5) | 10 012 (76.1) | 3958 (74.1) |
| Black or African American | 2087 (11.3) | 1406 (10.7) | 681 (12.7) |
| American Indian or Alaska Native, including Mexican Native | 1140 (6.2) | 805 (6.1) | 335 (6.3) |
| Asian | 810 (4.4) | 580 (4.4) | 230 (4.3) |
| Multiple | 338 (1.8) | 237 (1.8) | 101 (1.9) |
| Native Hawaiian or other Pacific Islander | 38 (0.2) | 31 (0.2) | 7 (0.1) |
| Not reported | 112 (0.6) | 81 (0.6) | 31 (0.6) |
| Hispanic or Latino, n (%) | |||
| No | 14 379 (77.7) | 10 242 (77.9) | 4137 (77.4) |
| Yes | 4074 (22.0) | 2878 (21.9) | 1196 (22.4) |
| Not reported | 25 (0.1) | 17 (0.1) | 8 (0.1) |
| Unknown | 17 (0.1) | 15 (0.1) | 2 (0.0) |
| Overall high risk of COVID-19, n (%) | |||
| Yes | 17 635 (95.4) | 12 536 (95.3) | 5099 (95.4) |
| No | 860 (4.6) | 616 (4.7) | 244 (4.6) |
| Coexisting conditions, n (%) | |||
| Any | 8970 (48.5) | 6261 (47.6) | 2709 (50.7) |
| Obesity | 7060 (38.2) | 4908 (37.3) | 2152 (40.3) |
| Chronic lung disease | 2772 (15.0) | 1922 (14.6) | 850 (15.9) |
| Type 2 diabetes | 1531 (8.3) | 1032 (7.8) | 499 (9.3) |
| Cardiovascular disease | 228 (1.2) | 157 (1.2) | 71 (1.3) |
| Chronic kidney disease | 141 (0.8) | 94 (0.7) | 47 (0.9) |
| HIV, n (%) | 141 (0.8) | 110 (0.8) | 31 (0.6) |
| Day of first crossover dose relative to 1 January 2021, median [IQR] | 115.0 [111.0, 118.0] |
115.0 [111.0, 119.0] |
115.0 [111.0, 118.0] |
| Months between second dose of primary series to second dose of crossover series, median [IQR] | 2.8 [2.5, 3.2] | 2.8 [2.5, 3.3] | 2.8 [2.5, 3.2] |
| Months between second dose of NVX-CoV2373 and 24 July 2021, median [IQR] | 4.6 [1.6, 5.2] | 4.9 [4.5, 5.4] | 1.4 [1.3, 1.6] |
Abbreviations: COVID-19, coronavirus disease 2019; HIV, human immunodeficiency virus; IQR, interquartile range.
aOriginal treatment arm.
b24 July 2021 is the date the last subject received the first crossover dose (includes 76 events in the placebo arm and 18 events in the NVX-CoV2373 arm).