Table 2.
Safety set of solicited adverse events – any grade - reported in the active groups for mRNA-1273 for BNT162b2, mRNA-1273, and AD26.COV2.S.
| BNT162b2 |
mRNA-1273 |
AD26.COV2.S |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 1st dose (N = 4040) |
2nd dose (N = 3705) |
1st dose (N = 15168) |
2nd dose (N = 14677) |
1st single-dose (N = 3356) |
||||||
| AEs | nAEs (%) | 95% CI | nAEs (%) | 95% CI | nAEs (%) | 95% CI | nAEs (%) | 95% CI | nAEs (%) | 95% CI |
| Arthralgia/joint pain | 406 (10·0) | 9·1 – 11·0 | 772 (20·8) | 19·5 – 22·1 | 2511 (16·6) | 16·0 – 17·1 | 6284 (42·8) | 42·0 – 43·6 | ||
| Antipyretic/Analgesic use | 996 (24·7) | 23·3 – 26·0 | 1570 (42·4) | 42·4 – 44·0 | 668 (19·9) | 18·6 – 21·3 | ||||
| Any local AR | 12765 (84·2) | 83·6 – 84·7 | 13006 (88·6) | 88·1 – 89·1 | 1685 (50·2) | 48·5 – 51·9 | ||||
| Any systemic AEs | 8320 (54·9) | 54·1 – 55·6 | 11652 (79·4) | 78·7 – 80·0 | 1850 (55·1) | 53·4 – 56·8 | ||||
| Chills | 434 (10·7) | 9·8 – 11·7 | 1114 (30·1) | 28·6 – 31·5 | 1253 (8·3) | 7·8 – 8·7 | 6482 (44·2) | 43·4 – 45·0 | ||
| Fatigue | 1700 (42·1) | 40·6 – 43·6 | 2086 (56·3) | 54·7 – 57·9 | 5635 (37·2) | 36·4 – 37·9 | 9582 (65·3) | 64·5 – 66·1 | 1283 (38·2) | 36·6 – 39·9 |
| Fever | 111 (2·7) | 2·2 – 3·3 | 512 (13·8) | 12·7 – 14·9 | 115 (0·8) | 0·6 – 0·9 | 2278 (15·5) | 14·9 – 16·1 | 302 (9·0) | 8·0 – 10·0 |
| Headache | 1413 (35·0) | 33·5 – 36·4 | 1732 (46·7) | 45·1 – 48·4 | 4951 (32·6) | 31·9 – 33·4 | 8602 (58·6) | 57·8 – 59·4 | 1306 (38·9) | 37·3 – 40·6 |
| Local erythema/redness | 189 (4·7) | 4·0 – 5·3 | 243 (6·6) | 5·8 – 7·4 | 430 (2·8) | 2·6 – 3·1 | 1257 (8·6) | 8·1 – 9·0 | 245 (7·3) | 6·4 – 8·2 |
| Local pain | 3186 (78·9) | 77·6 – 80·1 | 2730 (73·7) | 72·3 – 75·1 | 12690 (83·7) | 83·1 – 84·3 | 12943 (88·2) | 87·7 – 88·7 | 1632 (48·6) | 46·9 – 50·3 |
| Local swelling | 250 (6·2) | 5·4 – 6·9 | 256 (6·9) | 6·1 – 7·7 | 932 (6·1) | 5·8 – 6·5 | 1789 (12·2) | 11·7 – 12·7 | 178 (5·3) | 4.5 – 6·1 |
| Myalgia/muscle pain | 738 (18·3) | 17·1 – 19·5 | 1260 (34·0) | 32·5 – 35·5 | 3441 (22·7) | 0·22 – 23·4 | 8508 (58·0) | 57·2 – 58·8 | 1113 (33.2) | 31·6 – 34·8 |
| Nausea/vomiting | 37 (0·9) | 0·6 – 1·2 | 51 (1·4) | 1·0 – 1·8 | 1262 (8·3) | 7·9 – 8·8 | 2785 (19·0) | 18·3 – 19·6 | 477 (14·2) | 13 – 15·4 |
Abbreviations: N= sample size. AEs= Adverse Events. n AEs= number of Adverse Events. CI= Confidence Interval. AR= Adverse reaction.
a 95% confidence intervals are indicated (inferior value of the interval - superior value of the interval).
b The bold lines represent the most frequently reported symptoms.
c The absence of an AE in one trial, which was reported in the others, was considered in terms of an absence of the symptom and depicted as grey cells.