Table 1.
Symptomatic Covid-19 endpointsa by subgroup and randomization arm in the per-protocol cohort of each trial excluding South African participants and intersex participants (# endpoints / total # participants).
|
Moderna |
AstraZeneca |
Janssen |
Novavax |
|||||
|---|---|---|---|---|---|---|---|---|
| Placebo | Vaccine | Placebo | Vaccine | Placebo | Vaccine | Placebo | Vaccine | |
| Overall | 741/14164 | 55/14287 | 181/8528 | 134/17617 | 538/17113 | 173/17111 | 77/8385 | 17/17272 |
| Socio-demographic | ||||||||
| Age (years) | ||||||||
| 18–29 | 88/1391 | 5/1417 | 29/1072 | 33/2209 | 96/1762 | 32/1774 | 26/1259 | 4/2735 |
| 30–39 | 138/2143 | 11/2169 | 31/1365 | 22/2756 | 71/1970 | 32/1992 | 14/1649 | 5/3338 |
| 40–49 | 180/2665 | 12/2597 | 42/1526 | 41/3281 | 112/3507 | 46/3526 | 14/1676 | 2/3601 |
| 50–59 | 170/2878 | 12/2969 | 39/1762 | 27/3658 | 136/3740 | 25/3680 | 14/1923 | 4/3757 |
| 60–69 | 109/3240 | 10/3339 | 33/1875 | 9/3818 | 90/4437 | 32/4360 | 7/1433 | 1/2946 |
| ≥70 | 56/1847 | 5/1796 | 7/928 | 2/1895 | 33/1697 | 6/1779 | 2/445 | 1/895 |
| Ethnicity | ||||||||
| Hispanic/Latino | 176/2787 | 10/2831 | 59/2064 | 59/4032 | 250/8889 | 93/8767 | 18/1801 | 9/3707 |
| Not Hispanic/ Latino | 565/11377 | 45/11456 | 122/6464 | 75/13585 | 288/8224 | 80/8344 | 59/6584 | 8/13565 |
| Race | ||||||||
| American Indian/Alaska Nativeb | 5/113 | 0/109 | 20/372 | 26/747 | 65/1616 | 27/1641 | 6/522 | 1/1068 |
| Asian | 29/700 | 1/628 | 4/355 | 4/738 | 15/639 | 5/699 | 5/375 | 0/757 |
| Black or African American | 41/1352 | 4/1395 | 15/699 | 6/1401 | 30/1451 | 10/1416 | 8/947 | 1/1881 |
| Other | 30/422 | 1/464 | 3/164 | 2/338 | 24/621 | 6/589 | 1/54 | 0/146 |
| Multiple | 8/304 | 1/300 | 10/203 | 7/421 | 36/951 | 9/928 | 0/137 | 2/296 |
| White | 628/11273 | 48/11391 | 129/6735 | 89/13972 | 368/11835 | 116/11838 | 57/6350 | 13/13124 |
| Sex | ||||||||
| Female | 365/6670 | 25/6848 | 66/3714 | 56/7732 | 239/7629 | 73/7617 | 50/4158 | 10/8283 |
| Male | 376/7494 | 30/7439 | 115/4814 | 78/9885 | 299/9484 | 100/9494 | 27/4227 | 7/8989 |
| Health Characteristics | Placebo | Vaccine | Placebo | Vaccine | Placebo | Vaccine | Placebo | Vaccine |
| Body mass index (kg/m2) | ||||||||
| Healthy weight or Underweight (<25) | 150/3861 | 6/3970 | 41/2482 | 32/5275 | 163/5379 | 58/5501 | 29/2463 | 4/5220 |
| Overweight (≥25, <30) | 267/4938 | 20/4857 | 62/3079 | 44/6406 | 245/7055 | 73/6901 | 14/2719 | 7/5610 |
| Obese (≥30) | 324/5365 | 29/5460 | 78/2967 | 58/5936 | 130/4679 | 42/4709 | 34/3203 | 6/6442 |
| Class 3 Obese (≥40) | 74/995 | 7/1015 | 12/473 | 10/976 | 17/601 | 7/643 | 7/572 | 3/1267 |
| Cardiovascular Disease | 196/4472 | 19/4468 | 49/2392 | 20/5057 | 116/4550 | 24/4422 | 18/2021 | 4/4059 |
| Diabetes | 76/1468 | 5/1484 | 19/873 | 10/1627 | 42/1587 | 17/1608 | 7/858 | 2/1622 |
| HIV | 5/87 | 0/93 | 6/134 | 1/278 | 7/274 | 3/240 | 1/49 | 0/135 |
| Kidney Disease | 4/74 | 0/73 | 2/45 | 0/131 | 3/113 | 0/106 | 1/56 | 0/125 |
| Liver disease | 5/101 | 1/113 | 9/160 | 1/308 | 6/168 | 2/169 | 0/62 | 1/134 |
| Chronic Lung Disease | 37/808 | 5/808 | 13/1055 | 14/2027 | 44/1150 | 16/1114 | 9/1264 | 1/2461 |
| Risk Characteristics | Placebo | Vaccine | Placebo | Vaccine | Placebo | Vaccine | Placebo | Vaccine |
| Workplace Risk of Exposurec | ||||||||
| Low | 49/2666 | 36/5204 | 497/16355 | 159/16390 | 39/4951 | 7/9956 | ||
| Medium | 368/6735 | 30/6760 | 93/3765 | 61/7734 | 14/229 | 3/249 | 27/2670 | 6/5607 |
| High | 373/7429 | 25/7527 | 39/2097 | 37/4679 | 27/529 | 11/472 | 11/764 | 4/1709 |
| Risk from Living Conditiond | ||||||||
| Low | 113/2354 | 8/2322 | 78/4365 | 47/9044 | 232/8676 | 66/8739 | 57/6808 | 13/14002 |
| Medium | 564/10229 | 40/10348 | 33/1593 | 25/3227 | 189/4978 | 57/4923 | 16/1117 | 3/2274 |
| High | 40/1179 | 5/1165 | 29/1336 | 25/2744 | 97/2694 | 38/2683 | 2/339 | 0/733 |
| Very High | 24/402 | 2/452 | 41/1234 | 37/2602 | 20/765 | 12/766 | 2/121 | 1/263 |
| Tobacco use | 12/253 | 2/236 | 31/1705 | 22/3471 | 8/369 | 5/374 | 24/2609 | 6/5330 |
| Geographic Location | ||||||||
| USA | 741/14164 | 55/14287 | 145/7423 | 89/15389 | 331/9121 | 95/9156 | 73/7887 | 16/16261 |
| Argentina | 44/1414 | 20/1400 | ||||||
| Brazil | 43/3385 | 12/3394 | ||||||
| Chile | 10/670 | 9/1358 | 6/539 | 3/528 | ||||
| Colombia | 86/1862 | 34/1856 | ||||||
| Mexico | 5/218 | 2/207 | 4/498 | 1/1011 | ||||
| Peru | 26/435 | 36/870 | 23/574 | 7/570 | ||||
Excluded variants were: Beta, Delta, Epsilon, Eta, Gamma, Iota, Lambda, Mu, Kappa, and Zeta.
All participants were right censored at time t0 regardless of whether they were observed to experience event after t0. Separate time points t0 were chosen for each trial such that about 10 % participants are at risk in the vaccine arm.
Category is defined across all clinical sites. Indigenous people from South America were classified together with the American Indian or Alaska Native United States 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 222, 1119, 3257, and 1590 participants, respectively, who identified as American Indian or Alaskan Native from North America.
Detailed derivation of exposure risk based on OSHA categories is provided in Supplemental Methods.
Living condition encompasses housing type and household size, detailed derivation provided in Supplemental Methods.