Table. Baseline Characteristics and Clinical Characteristics of Placebo Recipients Who Developed COVID-19 in 1 of 4 CoVPN Phase 3 COVID-19 Vaccine Efficacy Trials, With SARS-CoV-2 Viral Load Measured at COVID-19 Diagnosis.
| Characteristic | Parent protocol | ||||
|---|---|---|---|---|---|
| Moderna (n = 594) | AstraZeneca (n = 97) | Janssen (n = 916) | Novavax (n = 60) | Total (n = 1667) | |
| Sex assigned at birth, No. (%) | |||||
| Female | 293 (49.3) | 33 (34.0) | 417 (45.5) | 38 (63.3) | 781 (46.9) |
| Male | 301 (50.7) | 64 (66.0) | 499 (54.5) | 22 (36.7) | 886 (53.1) |
| Country, No. (%) | |||||
| Argentina | 0 | 0 | 95 (10.4) | 0 | 95 (5.7) |
| Brazil | 0 | 0 | 169 (18.4) | 0 | 169 (10.1) |
| Chile | 0 | 7 (7.2) | 9 (1.0) | 0 | 16 (1.0) |
| Colombia | 0 | 0 | 192 (21.0) | 0 | 192 (11.5) |
| Mexico | 0 | 0 | 8 (0.9) | 4 (6.7) | 12 (0.7) |
| Peru | 0 | 20 (20.6) | 84 (9.2) | 0 | 104 (6.2) |
| South Africa | 0 | 0 | 84 (9.2) | 0 | 84 (5.0) |
| US | 594 (100.0) | 70 (72.2) | 275 (30.0) | 56 (93.3) | 995 (59.7) |
| Self-reported race, No. (%)a | |||||
| American Indian or Alaska Nativeb | 4 (0.7) | 16 (16.5) | 172 (18.8) | 4 (6.7) | 196 (11.8) |
| Asian | 23 (3.9) | 0 | 14 (1.5) | 4 (6.7) | 41 (2.5) |
| Black or African American | 29 (4.9) | 6 (6.2) | 110 (12.0) | 5 (8.3) | 150 (9.0) |
| Multiple | 7 (1.2) | 4 (4.1) | 99 (10.8) | 0 | 110 (6.6) |
| Not reported | 10 (1.7) | 1 (1.0) | 33 (3.6) | 1 (1.7) | 42 (2.7) |
| White | 508 (85.5) | 70 (72.2) | 488 (53.3) | 46 (76.7) | 1112 (66.7) |
| Other | 13 (2.2) | 0 | 0 | 0 | 13 (0.8) |
| Ethnicity, No. (%) | |||||
| Hispanic or Latino | 134 (22.6) | 36 (37.1) | 580 (63.3) | 12 (20.0) | 762 (45.7) |
| Not Hispanic or Latino | 458 (77.1) | 60 (61.9) | 319 (34.8) | 48 (80.0) | 885 (53.1) |
| Not reported | 2 (0.3) | 1 (1.0) | 17 (1.9) | 0 | 20 (1.2) |
| Age category, No. (%), y | |||||
| 18-29 | 70 (11.8) | 18 (18.6) | 168 (18.3) | 18 (30.0) | 274 (16.4) |
| 30-39 | 108 (18.2) | 14 (14.4) | 122 (13.3) | 11 (18.3) | 255 (15.3) |
| 40-49 | 141 (23.7) | 25 (25.8) | 226 (24.7) | 10 (16.7) | 402 (24.1) |
| 50-64 | 194 (32.7) | 28 (28.9) | 292 (31.9) | 18 (30.0) | 532 (31.9) |
| ≥65 | 81 (13.6) | 12 (12.4) | 108 (11.8) | 3 (5.0) | 204 (12.2) |
| BMI category, No. (%) | |||||
| <18.5 | 3 (0.5) | 1 (1.0) | 6 (0.7) | 0 | 10 (0.6) |
| 18.5-<25.0 | 115 (19.4) | 24 (24.7) | 263 (28.7) | 23 (38.3) | 425 (25.5) |
| ≥25.0 | 472 (79.5) | 71 (73.2) | 646 (70.5) | 37 (61.7) | 1226 (73.5) |
| Missing | 4 (0.7) | 1 (1.0) | 1 (0.1) | 0 | 6 (0.4) |
| COVID-19 comorbidities, No. (%) | 138 (23.2) | 61 (62.9) | 346 (37.8) | 32 (53.3) | 577 (34.6) |
| Severe COVID-19 symptoms, No. (%) | 81 (13.6) | 4 (4.1) | 175 (19.1) | 3 (5.0) | 263 (15.8) |
| Days since COVID-19 onset, No. (%)c | |||||
| −1 | 25 (4.2) | 0 | 0 | 0 | 25 (1.5) |
| −2 | 10 (1.7) | 0 | 0 | 0 | 10 (0.6) |
| 0 | 554 (93.3) | 97 (100.0) | 263 (28.7) | 12 (20.0) | 926 (55.5) |
| 1 | 3 (0.5) | 0 | 312 (34.1) | 12 (20.0) | 327 (19.6) |
| 2 | 2 (0.3) | 0 | 149 (16.3) | 22 (36.7) | 173 (10.4) |
| 3 | 0 | 0 | 96 (10.5) | 12 (20.0) | 108 (6.5) |
| 4 | 0 | 0 | 96 (10.5) | 2 (3.3) | 98 (5.9) |
| Infecting variant: No. (%) | |||||
| Ancestral | 435 (73.2) | 43 (44.3) | 376 (41.0) | 13 (21.7) | 867 (52.0) |
| Alpha | 0 | 9 (9.3) | 25 (2.7) | 24 (40.0) | 58 (3.5) |
| Beta | 0 | 0 | 49 (5.3) | 1 (1.7) | 50 (3.0) |
| Gamma | 1 (0.2) | 1 (1.0) | 105 (11.5) | 3 (5.0) | 110 (6.6) |
| Epsilon | 13 (2.2) | 5 (5.2) | 16 (1.7) | 3 (5.0) | 37 (2.2) |
| Zeta | 1 (0.2) | 0 | 74 (8.1) | 1 (1.7) | 76 (4.6) |
| Iota | 0 | 0 | 4 (0.4) | 2 (3.3) | 6 (0.4) |
| Delta | 0 | 0 | 7 (0.8) | 0 | 7 (0.4) |
| Lambda | 0 | 16 (16.5) | 43 (4.7) | 0 | 59 (3.5) |
| Mu | 0 | 0 | 53 (5.8) | 0 | 53 (3.2) |
| No sequence | 144 (24.2) | 23 (23.7) | 164 (17.9) | 13 (21.7) | 344 (20.6) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CoVPN, COVID Vaccine Prevention Network.
Self-reported race is defined across all clinical sites. Participants were asked to select all applicable categories, including “Other”; Multiple indicates more than one self-reported category; Not reported indicates a missing response.
Indigenous people from South America were classified together with the American Indian or Alaska Native US and Mexico demographic according to the FDA definition (American Indian or Alaska Native: A person having origins in any of the original peoples of North and South America (including Central America), and who maintains tribal affiliation or community attachment). In this analysis, the Moderna, AstraZeneca, Janssen, and Novavax trials included 4, 1, 5, and 4 participants, respectively, who identified as American Indian or Alaskan Native from North America.
Days since COVID-19 onset is defined as the number of calendar days between protocol-defined onset of COVID-19 and the specimen collection corresponding to diagnosis. Negative days since onset in Moderna implies the positive swab was obtained before qualifying symptom onset.