Table 1. Demographic and Clinical Characteristics of the Participants at Baseline (before Trial Vaccination).*.
| Characteristic | BNT162b2, 30 μg (N=305) |
BNT162b2, 60 μg (N=302) |
Monovalent BA.1, 30 μg (N=307) |
Monovalent BA.1, 60 μg (N=306) |
Bivalent BA.1, 30 μg (N=305) |
Bivalent BA.1, 60 μg (N=316) |
Total (N=1841) |
|---|---|---|---|---|---|---|---|
| Median age (range) — yr | 66.0 (56 to 87) | 67.0 (56 to 86) | 67.0 (56 to 84) | 67.0 (56 to 87) | 67.0 (56 to 85) | 67.0 (56 to 87) | 67.0 (56 to 87) |
| Male sex — no. (%) | 145 (47.5) | 145 (48.0) | 154 (50.2) | 153 (50.0) | 162 (53.1) | 153 (48.4) | 912 (49.5) |
| Race — no. (%)† | |||||||
| White | 268 (87.9) | 254 (84.1) | 261 (85.0) | 262 (85.6) | 274 (89.8) | 275 (87.0) | 1594 (86.6) |
| Black | 19 (6.2) | 22 (7.3) | 23 (7.5) | 20 (6.5) | 13 (4.3) | 19 (6.0) | 116 (6.3) |
| Asian | 13 (4.3) | 20 (6.6) | 16 (5.2) | 19 (6.2) | 16 (5.2) | 17 (5.4) | 101 (5.5) |
| Other‡ | 5 (1.6) | 6 (2.0) | 7 (2.3) | 5 (1.6) | 2 (0.7) | 5 (1.6) | 30 (1.6) |
| Ethnic group — no. (%)† | |||||||
| Hispanic or Latinx | 57 (18.7) | 38 (12.6) | 44 (14.3) | 46 (15.0) | 45 (14.8) | 44 (13.9) | 274 (14.9) |
| Not Hispanic or Latinx | 248 (81.3) | 264 (87.4) | 263 (85.7) | 260 (85.0) | 260 (85.2) | 272 (86.1) | 1567 (85.1) |
| SARS-CoV-2 status — no. (%) | |||||||
| Positive§ | 41 (13.4) | 28 (9.3) | 45 (14.7) | 41 (13.4) | 38 (12.5) | 39 (12.3) | 232 (12.6) |
| Negative¶ | 262 (85.9) | 274 (90.7) | 261 (85.0) | 265 (86.6) | 267 (87.5) | 277 (87.7) | 1606 (87.2) |
| Missing data | 2 (0.7) | 0 | 1 (0.3) | 0 | 0 | 0 | 3 (0.2) |
| Interval between third dose and trial vaccination — mo | |||||||
| Mean | 6.8±1.44 | 6.8±1.42 | 6.8±1.37 | 6.9±1.49 | 6.8±1.39 | 6.9±1.45 | 6.8±1.43 |
| Median (range) | 6.3 (5.3 to 13.1) | 6.3 (5.3 to 12.9) | 6.3 (5.1 to 11.4) | 6.3 (5.4 to 12.8) | 6.3 (4.7 to 11.5) | 6.3 (5.3 to 11.2) | 6.3 (4.7 to 13.1) |
| Distribution — no. (%) | |||||||
| <5 | 0 | 0 | 0 | 0 | 1 (0.3) | 0 | 1 (<0.1) |
| 5 to <7 | 234 (76.7) | 235 (77.8) | 233 (75.9) | 223 (72.9) | 230 (75.4) | 229 (72.5) | 1384 (75.2) |
| 7 to <9 | 40 (13.1) | 39 (12.9) | 47 (15.3) | 48 (15.7) | 43 (14.1) | 51 (16.1) | 268 (14.6) |
| 9 to <11 | 28 (9.2) | 22 (7.3) | 23 (7.5) | 31 (10.1) | 26 (8.5) | 30 (9.5) | 160 (8.7) |
| ≥11 | 3 (1.0) | 6 (2.0) | 4 (1.3) | 4 (1.3) | 5 (1.6) | 6 (1.9) | 28 (1.5) |
| Body-mass index — no. (%)‖ | |||||||
| <18.5 | 4 (1.3) | 4 (1.3) | 0 | 3 (1.0) | 1 (0.3) | 3 (0.9) | 15 (0.8) |
| ≥18.5 to 24.9 | 85 (27.9) | 91 (30.1) | 79 (25.7) | 78 (25.5) | 71 (23.3) | 84 (26.6) | 488 (26.5) |
| ≥25.0 to 29.9 | 108 (35.4) | 90 (29.8) | 120 (39.1) | 121 (39.5) | 129 (42.3) | 113 (35.8) | 681 (37.0) |
| ≥30.0 | 108 (35.4) | 117 (38.7) | 108 (35.2) | 104 (34.0) | 104 (34.1) | 115 (36.4) | 656 (35.6) |
| Missing data | 0 | 0 | 0 | 0 | 0 | 1 (0.3) | 1 (<0.1) |
Plus–minus values are means ±SD. Data are for the safety population (all participants who had undergone randomization and received a trial vaccine). Demographic characteristics of the sentinel cohort are shown in Table S3. The participants were randomly assigned to receive the original 30-μg dose or a 60-μg dose of BNT162b2, a 30-μg or 60-μg dose of monovalent B.1.1.529 (omicron) BA.1–adapted BNT162b2 vaccine (monovalent BA.1), or bivalent combinations thereof (30-μg bivalent BA.1 [15 μg of BNT162b2+15 μg of monovalent BA.1] or 60-μg bivalent BA.1 [30 μg of BNT162b2+30-μg of monovalent BA.1]).
Race and ethnic group were reported by the participant.
“Other” includes the following subgroups: multiracial (21 participants [1.1%]); Native Hawaiian or Pacific Islander (3 participants [0.2%]); American Indian or Alaska Native (3 participants [0.2%]); and not reported (3 participants [0.2%]).
Positive status was defined as a positive SARS-CoV-2 nucleoprotein–binding (N-binding) antibody test at baseline, a positive nucleic acid amplification test (NAAT) at baseline, or a medical history of Covid-19.
Negative status was defined as a negative N-binding antibody test at baseline, a negative NAAT at baseline, and no medical history of Covid-19.
The body-mass index is the weight in kilograms divided by the square of the height in meters.