Table 3.
Safety set of solicited adverse events - any grade - reported in the placebo 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 = 3699) |
1st dose (N = 15155) |
2nd dose (N = 14566) |
1st single-dose (N = 3380) |
||||||
| AEs | nAEs (%) | 95% CI | nAEs (%) | 95% CI | nAEs (%) | 95% CI | nAEs (%) | 95% CI | nAEs (%) | 95% CI |
| Arthralgia/joint pain | 247 (6·1) | 5·4 – 6·9 | 170 (4·6) | 3·9 – 5·3 | 1783 (11·8) | 11·3 – 12·3 | 1569 (10·8) | 10·3 – 11·3 | ||
| Antipyretic/Analgesic use | 545 (13·5) | 12·4 – 14·5 | 427 (11·5) | 10·5 – 12·6 | 191 (5·7) | 4·9 – 6·4 | ||||
| Any local AR | 2997 (19·8) | 19·1 – 20·4 | 2735 (18·8) | 18·1 – 19·4 | 657 (19·4) | 18·1 – 20·8 | ||||
| Any systemic AEs | 6399 (42·2) | 41·4 – 43·0 | 5323 (36·5) | 35·8 – 37·3 | 1185 (35·1) | 33·5 – 36·7 | ||||
| Chills | 203 (5·0) | 4·4 – 5·7 | 125 (3·4) | 2·8 – 4·0 | 878 (5·8) | 5·4 – 6·2 | 809 (5·6) | 5·2 – 5·9 | ||
| Fatigue | 1172 (29·0) | 27·6 – 30·4 | 756 (20·4) | 19·1 – 21·7 | 4133 (27·3) | 26·6 – 28·0 | 3403 (23·4) | 22·7 – 24·0 | 728 (21·5) | 20·2 – 22·9 |
| Fever | 27 (0·7) | 0·4 – 0·9 | 14 (0·4) | 0·2 – 0·6 | 44 (0·3) | 0·2 – 0·4 | 43 (0·3) | 0·2 – 0·4 | 20 (0·6) | 0·3 – 0·9 |
| Headache | 1100 (27·2) | 25·9 – 28·6 | 735 (19·9) | 18·6 – 21·2 | 4027 (26·6) | 25·9 – 27·3 | 3410 (23·4) | 22·7 – 24·1 | 802 (23·7) | 22·3 – 25·2 |
| Local erythema/redness | 45 (1·1) | 0·8 – 1·4 | 26 (0·7) | 0·4 – 1·0 | 67 (0·4) | 0·3 – 0·5 | 56 (0·4) | 0·3 – 0·5 | 131 (3·9) | 3·2 – 4·5 |
| Local pain | 488 (12·1) | 11·1 – 13·1 | 372 (10·1) | 9·1 – 11·0 | 2658 (17·5) | 16·9 – 18·1 | 2477 (17·0) | 16·4 – 17·6 | 564 (16·7) | 15·4 – 17·9 |
| Local swelling | 32 (0·8) | 0·5 – 1·1 | 16 (0·4) | 0·2 – 0·6 | 52 (0·3) | 0·3 – 0·4 | 49 (0·3) | 0·2 – 0·4 | 53 (1·6) | 1·1 – 2·0 |
| Myalgia/muscle pain | 398 (9·9) | 8·9 – 10·8 | 260 (7·0) | 6·2 – 7·9 | 2071 (13·7) | 13·1 – 14·2 | 1809 (12·4) | 11·9 – 13·0 | 430 (12·7) | 11·6 – 13·8 |
| Nausea/vomiting | 37 (0·9) | 0·6 – 1·2 | 30 (0·8) | 0·5 – 1·1 | 1074 (7·1) | 6·7 – 7·5 | 934 (6·4) | 6·0 – 6·8 | 327 (9·7) | 8·7 – 10·7 |
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 both the most frequently reported symptoms and a decrease in reported adverse reactions following the second dose in comparison to the first dose (only the difference between mRNA-1273 groups for local pain was not statistically significant).
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.