Table 2.
Solicited Local and Systemic Adverse Events after Inoculation in Volunteers, Classified by Arm and Age Group
| First Dose | Second Dose | Both Doses | |||||||
|---|---|---|---|---|---|---|---|---|---|
| (n = 434) | (n = 319) | (n = 319) | |||||||
| Adverse Reaction | Placebo (n = 164) | Vaccine (n = 270) | P Value | Placebo (n = 80)a |
Vaccine (n = 239) | P Value | Placebo (n = 80) | Vaccine (n = 239) | P Value |
| Local reactions | |||||||||
| Pain, n (%)b | 39 (23.8) | 117 (43.3) | <.001 | 16 (20.0) | 73 (30.5) | .069 | 32 (40.0) | 133 (55.6) | .015 |
| <60 y | 37 (24.3) | 113 (46.1) | <.001 | 15 (20.8) | 68 (31.8) | .077 | 30 (41.7) | 125 (58.4) | .014 |
| ≥60 y | 2 (16.7) | 4 (16.0) | .999 | 1 (12.5) | 5 (20.0) | .999 | 2 (25.0) | 8 (32.0) | .999 |
| Induration (%) | 1 (0.6) | 8 (3.0) | .163 | 0 (0.0) | 15 (6.3) | .015 | 0 (0.0) | 21 (8.8) | .006 |
| <60 y | 1 (0.7) | 7 (2.9) | .161 | 0 (0.0) | 13 (6.1) | .043 | 0 (0.0) | 18 (8.4) | .009 |
| ≥60 y | 0 (0.0) | 1 (4.0) | .999 | 0 (0.0) | 2 (8.0) | .999 | 0 (0.0) | 3 (12.0) | .56 |
| Pruritus (%) | 4 (2.4) | 15 (5.6) | .124 | 2 (2.5) | 6 (2.5) | .099 | 3 (3.8) | 17 (7.1) | .283 |
| <60 y | 4 (2.6) | 15 (6.1) | .113 | 2 (2.8) | 6 (2.8) | .099 | 3 (4.2) | 17 (7.9) | .277 |
| ≥60 y | 0 (0.0) | 0 (0.0) | … | 0 (0.0) | 0 (0.0) | … | 0 (0.0) | 0 (0.0) | … |
| Erythema (%) | 3 (1.8) | 10 (3.7) | .386 | 2 (2.5) | 3 (1.3) | .602 | 2 (2.5) | 10 (4.2) | .737 |
| <60 y | 3 (2.0) | 10 (4.1) | .385 | 1 (1.4) | 3 (1.4) | .999 | 1 (1.4) | 10 (4.7) | .301 |
| ≥60 y | 0 (0.0) | 0 (0.0) | … | 1 (12.5) | 0 (0.0) | .242 | 1 (12.5) | 0 (0,0.0) | .242 |
| Swelling (%) | 3 (1.8) | 5 (1.9) | .999 | 1 (1.3) | 5 (2.1) | .999 | 1 (1.3) | 9 (3.8) | .461 |
| <60 y | 3 (2.0) | 5 (2.0) | .999 | 1 (1.4) | 4 (1.9) | .999 | 1 (1.4) | 8 (3.7) | .458 |
| ≥60 y | 0 (0.0) | 0 (0.0) | … | 0 (0.0) | 1 (4.0) | .999 | 0 (0.0) | 1 (4.0) | .999 |
| Systemic reactions | |||||||||
| Headache (%) | 50 (30.5) | 107 (39.6) | .055 | 15 (18.8) | 46 (19.2) | .922 | 39 (48.8) | 116 (48.5) | .974 |
| <60 y | 49 (32.2) | 102 (41.6) | .061 | 12 (16.7) | 42 (19.6) | .579 | 36 (50.0) | 109 (50.9) | .891 |
| ≥60 y | 1 (8.3) | 5 (20.0) | .641 | 3 (37.5) | 4 (16.0) | .32 | 3 (37.5) | 7 (28.0) | .673 |
| Fatigue (%) | 32 (19.5) | 58 (21.5) | .624 | 10 (12.5) | 25 (10.5) | .613 | 22 (27.5) | 64 (26.8) | .9 |
| <60 y | 31 (20.4) | 55 (22.4) | .629 | 8 (11.1) | 23 (10.7) | .932 | 20 (27.8) | 60 (28.0) | .966 |
| ≥60 y | 1 (8.3) | 3 (12.0) | .999 | 2 (25.0) | 2 (8.0) | .241 | 2 (25.0) | 4 (16.0) | .616 |
| Myalgia (%) | 23 (14.0) | 48 (17.8) | .305 | 9 (11.3) | 19 (7.9) | .367 | 19 (23.8) | 54 (22.6) | .831 |
| <60 y | 22 (14.5) | 46 (18.8) | .269 | 8 (11.1) | 16 (7.5) | .336 | 18 (25.0) | 50 (23.4) | .778 |
| ≥60 y | 1 (8.3) | 2 (8.0) | .999 | 1 (12.5) | 3 (12.0) | .999 | 1 (12.5) | 4 (16.0) | .999 |
| Diarrhea (%) | 18 (11.0) | 36 (13.3) | .471 | 5 (6.3) | 18 (7.5) | .701 | 15 (18.8) | 44 (18.4) | .946 |
| <60 y | 17 (11.2) | 36 (14.7) | .318 | 4 (5.6) | 16 (7.5) | .58 | 14 (19.4) | 42 (19.6) | .973 |
| ≥60 y | 1 (8.3) | 0 (0.0) | .324 | 1 (12.5) | 2 (8.0) | .999 | 1 (12.5) | 2 (8.0) | .999 |
| Nausea (%) | 18 (11.0) | 25 (9.3) | .562 | 3 (3.8) | 9 (3.8) | .999 | 11 (13.8) | 27 (11.3) | .558 |
| <60 y | 18 (11.8) | 22 (9.0) | .357 | 2 (2.8) | 9 (4.2) | .736 | 10 (13.9) | 24 (11.2) | .544 |
| ≥60 y | 0 (0.0) | 3 (12.0) | .537 | 1 (12.5) | 0 (0.0) | .242 | 1 (12.5) | 3 (12.0) | .999 |
| Arthralgia (%) | 10 (6.1) | 14 (5.2) | .687 | 2 (2.5) | 7 (2.9) | .999 | 7 (8.8) | 18 (7.5) | .726 |
| <60 y | 10 (6.6) | 13 (5.3) | .596 | 2 (2.8) | 6 (2.8) | .999 | 7 (9.7) | 16 (7.5) | .544 |
| ≥60 y | 0 (0.0) | 1 (4.0) | .999 | 0 (0.0) | 1 (4.0) | .999 | 0 (0.0) | 2 (8.0) | .999 |
| Anorexia (%) | 10 (6.1) | 18 (6.7) | .815 | 3 (3.8) | 3 (1.3) | .169 | 6 (7.5) | 16 (6.7) | .806 |
| <60 y | 10 (6.6) | 16 (6.5) | .985 | 2 (2.8) | 3 (1.4) | .603 | 5 (6.9) | 14 (6.5) | .999 |
| ≥60 y | 0 (0.0) | 2 (8.0) | .999 | 1 (12.5) | 0 (0.0) | .242 | 1 (12.5) | 2 (8.0) | .999 |
| Pruritus (%) | 2 (1.2) | 10 (3.7) | .225 | 0 (0.0) | 4 (1.7) | .575 | 1 (1.3) | 14 (5.9) | .127 |
| <60 y | 2 (1.3) | 9 (3.7) | .217 | 0 (0.0) | 4 (1.9) | .575 | 1 (1.4) | 13 (6.1) | .202 |
| ≥60 y | 0 (0.0) | 1 (4.0) | .999 | 0 (0.0) | 0 (0.0) | … | 0 (0.0) | 1 (4.0) | .999 |
| Exanthema (%) | 1 (0.6) | 7 (2.6) | .268 | 0 (0.0) | 1 (0.4) | .999 | 1 (1.3) | 8 (3.3) | .459 |
| <60 y | 1 (0.7) | 7 (2.9) | .161 | 0 (0.0) | 1 (0.5) | .999 | 1 (1.4) | 8 (3.7) | .458 |
| ≥60 y | 0 (0.0) | 0 (0.0) | … | 0 (0.0) | 0 (0.0) | … | 0 (0.0) | 0 (0.0) | … |
| Allergy (%) | 1 (0.6) | 6 (2.2) | .262 | 0 (0.0) | 3 (1.3) | .575 | 0 (0.0) | 8 (3.3) | .209 |
| <60 y | 0 (0.0) | 5 (2.0) | .161 | 0 (0.0) | 2 (0.9) | .999 | 0 (0.0) | 4 (1.9) | .575 |
| ≥60 y | 1 (8.3) | 1 (4.0) | .999 | 0 (0.0) | 1 (4.0) | .999 | 0 (0.0) | 1 (4.0) | .999 |
| Vomiting (%) | 3 (1.8) | 1 (0.4) | .154 | 0 (0.0) | 4 (1.7) | .575 | 0 (0.0) | 4 (1.7) | .575 |
| <60 y | 3 (2.0) | 1 (0.4) | .159 | 0 (0.0) | 4 (1.9) | .575 | 0 (0.0) | 4 (1.9) | .575 |
| ≥60 y | 0 (0.0) | 0 (0.0) | … | 0 (0.0) | 0 (0.0) | … | 0 (0.0) | 0 (0.0) | … |
| Fever (>37.8ºC) (%) | 1 (0.6) | 1 (0.4) | .999 | 0 (0.0) | 0 (0.0) | … | 1 (1.3) | 1 (0.4) | .439 |
| <60 y | 1 (0.7) | 1 (0.4) | .999 | 0 (0.0) | 0 (0.0) | … | 1 (1.4) | 1 (0.5) | .441 |
| ≥60 y | 0 (0.0) | 0 (0.0) | … | 0 (0.0) | 0 (0.0) | … | 0 (0.0) | 0 (0.0) | … |
Data in the table were reported within 7 days after any of the 2 doses. Sample sizes: placebo < 60 first dose: n = 152; placebo < 60 second dose: n = 72; vaccine < 60 first dose: n = 245; vaccine < 60 second dose: n = 214; placebo ≥ 60 first dose: n = 12; placebo ≥ 60 second dose: n = 8; vaccine ≥ 60 first dose: n = 25; vaccine ≥ 60 years second dose: n = 25.
aAs of February 24, 2021, only 80 volunteers from the placebo arm had received their second dose.
bPercentages were calculated from the total number of volunteers in each group.