Table 1. Demographic and Clinical Characteristics of the Participants at Baseline (Per-Protocol Efficacy Analysis Population).*.
| Characteristic | NVX-CoV2373 (N=17,312) |
Placebo (N=8140) |
Total (N=25,452) |
|---|---|---|---|
| Median age (range) — yr | 47.0 (18–95) | 47.0 (18–90) | 47.0 (18–95) |
| Age group — no. (%) | |||
| 18 to 64 yr | 15,264 (88.2) | 7,194 (88.4) | 22,458 (88.2) |
| ≥65 yr | 2,048 (11.8) | 946 (11.6) | 2,994 (11.8) |
| Sex — no. (%) | |||
| Male | 9,050 (52.3) | 4,131 (50.7) | 13,181 (51.8) |
| Female | 8,262 (47.7) | 4,009 (49.3) | 12,271 (48.2) |
| Race or ethnic group — no. (%)† | |||
| White | 13,140 (75.9) | 6,184 (76.0) | 19,324 (75.9) |
| Black or African American | 1,893 (10.9) | 900 (11.1) | 2,798 (11.0) |
| American Indian or Alaska Native, including Mexican Natives | 1,074 (6.2) | 498 (6.1) | 1,572 (6.2) |
| Asian | 761 (4.4) | 366 (4.5) | 1,127 (4.4) |
| Multiple | 293 (1.7) | 132 (1.6) | 425 (1.7) |
| Native Hawaiian or other Pacific Islander | 47 (0.3) | 10 (0.1) | 57 (0.2) |
| Not reported | 104 (0.6) | 45 (0.6) | 149 (0.6) |
| Hispanic or Latino | |||
| No | 13,538 (78.2) | 6,379 (78.4) | 19,917 (78.3) |
| Yes | 3,733 (21.6) | 1,751 (21.5) | 5,484 (21.5) |
| Not reported | 22 (0.1) | 9 (0.1) | 31 (0.1) |
| Unknown | 19 (0.1) | 1 (<0.1) | 20 (0.1) |
| Overall high risk of Covid-19 — no. (%)‡ | |||
| Yes | 16,493 (95.3) | 7,737 (95.0) | 24,230 (95.2) |
| No | 819 (4.7) | 403 (5.0) | 1,222 (4.8) |
| High risk of severe Covid-19 — no. (%)§ | |||
| Yes | 9,046 (52.3) | 4,294 (52.8) | 13,340 (52.4) |
| No | 8,266 (47.7) | 3,846 (47.2) | 12,112 (47.6) |
| Coexisting conditions — no. (%) | |||
| Any | 8,117 (46.9) | 3,910 (48.0) | 12,027 (47.3) |
| Obesity | 6,400 (37.0) | 3,070 (37.7) | 9,470 (37.2) |
| Chronic lung disease | 2,442 (14.1) | 1,218 (15.0) | 3,660 (14.4) |
| Diabetes mellitus type 2 | 1,303 (7.5) | 677 (8.3) | 1,980 (7.8) |
| Cardiovascular disease | 191 (1.1) | 91 (1.1) | 282 (1.1) |
| Chronic kidney disease | 109 (0.6) | 50 (0.6) | 159 (0.6) |
| HIV infection — no. (%) | 128 (0.7) | 38 (0.5) | 166 (0.7) |
| Country — no. (%) | |||
| United States | 16,294 (94.1) | 7,638 (93.8) | 23,932 (94.0) |
| Mexico | 1,018 (5.9) | 502 (6.2) | 1,520 (6.0) |
The per-protocol efficacy analysis population included all participants who underwent randomization and received both doses as assigned, were seronegative for anti–SARS-CoV-2 nucleoprotein and had a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA RT-PCR–negative nasal swab at baseline, and did not have a censoring event at any time before 7 days after the second injection. HIV denotes human immunodeficiency virus.
Race and ethnic group were reported by the participants.
Participants at overall high risk included those 65 years of age or older and those of any age with chronic health conditions or an increased risk for Covid-19 because of work or living conditions.
Participants were classified as having a high risk of severe Covid-19 if they had one or more of the following coexisting conditions: obesity (defined as a body-mass index [the weight in kilograms divided by the square of the height in meters] of ≥30.0), chronic lung disease, diabetes mellitus type 2, cardiovascular disease, or chronic kidney disease.