Table 2.
Adverse events and reactions that occurred after any dose in the safety population*
|
Participants without a SARS-CoV-2 vaccination history |
Participants with a SARS-CoV-2 vaccination history |
Total |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vaccine group (n=6910) | Placebo group (n=6904) | Rate difference (95% CI) | p value | Vaccine group (n=8590) | Placebo group (n=8586) | Rate difference (95% CI) | p value | Vaccine group (n=15 500) | Placebo group (n=15 490) | Rate difference (95% CI) | p value | |
| Solicited adverse events within 7 days of either dose | ||||||||||||
| Any | 709 (10·3%) | 725 (10·5%) | −0·24 (−1·40 to 0·92) | 0·64 | 1262 (14·7%) | 1242 (14·5%) | 0·27 (−1·20 to 1·74) | 0·67 | 1971 (12·7%) | 1967 (12·7%) | 0·03 (−1·69 to 1·76) | 0·96 |
| Grade ≥3 | 41 (0·6%) | 38 (0·6%) | 0·04 (−0·24 to 0·33) | 0·74 | 45 (0·5%) | 35 (0·4%) | 0·14 (−0·15 to 0·43) | 0·26 | 86 (0·6%) | 73 (0·5%) | 0·19 (−0·22 to 0·59) | 0·30 |
| Solicited adverse reactions within 7 days of either dose | ||||||||||||
| Any | 675 (9·8%) | 685 (9·9%) | −0·15 (−1·29 to 0·98) | 0·76 | 1220 (14·2%) | 1202 (14·0%) | 0·20 (−0·99 to 1·39) | 0·70 | 1895 (12·2%) | 1887 (12·2%) | 0·04 (−0·79 to 0·88) | 0·91 |
| Grade ≥3 | 41 (0·6%) | 38 (0·6%) | 0·04 (−0·24 to 0·33) | 0·74 | 42 (0·5%) | 31 (0·4%) | 0·13 (−0·09 to 0·35) | 0·20 | 83 (0·5%) | 69 (0·4%) | 0·09 (−0·09 to 0·27) | 0·26 |
| Adverse events within 30 days after any dose | ||||||||||||
| Any | 898 (13·0%) | 901 (13·1%) | −0·05 (−1·34 to 1·23) | 0·92 | 1525 (17·8%) | 1515 (17·6%) | 0·11 (−1·20 to 1·41) | 0·85 | 2423 (15·6%) | 2416 (15·6%) | 0·04 (−0·89 to 0·96) | 0·93 |
| Grade ≥3 | 53 (0·8%) | 46 (0·7%) | 0·1 (−0·22 to 0·42) | 0·48 | 80 (0·9%) | 66 (0·8%) | 0·16 (−0·15 to 0·48) | 0·25 | 133 (0·9%) | 112 (0·7%) | 0·14 (−0·09 to 0·36) | 0·18 |
| Adverse reactions within 30 days after any dose | ||||||||||||
| Any | 685 (9·9%) | 701 (10·2%) | −0·24 (−1·39 to 0·91) | 0·64 | 1239 (14·4%) | 1223 (14·2%) | 0·18 (−1·02 to 1·38) | 0·74 | 1924 (12·4%) | 1924 (12·4%) | −0·01 (−0·85 to 0·83) | 0·98 |
| Grade ≥3 | 42 (0·6%) | 39 (0·6%) | 0·04 (−0·25 to 0·33) | 0·74 | 43 (0·5%) | 31 (0·4%) | 0·14 (−0·08 to 0·36) | 0·16 | 85 (0·5%) | 70 (0·5%) | 0·10 (−0·08 to 0·28) | 0·23 |
| Medically attended adverse events during the safety observation period | ||||||||||||
| Any | 61 (0·9%) | 45 (0·7%) | 0·23 (−0·10 to 0·56) | 0·12 | 359 (4·2%) | 376 (4·4%) | −0·02 (−0·89 to 0·49) | 0·52 | 420 (2·7%) | 421 (2·7%) | −0·01 (−0·42 to 0·41) | 0·96 |
| Grade ≥3 | 27 (0·4%) | 21 (0·3%) | 0·09 (−0·14 to 0·31) | 0·39 | 107 (1·2%) | 104 (1·2%) | 0·03 (−0·34 to 0·41) | 0·84 | 134 (0·9%) | 125 (0·8%) | 0·06 (−0·17 to 0·29) | 0·58 |
| Adverse events of special interest during the safety observation period | ||||||||||||
| Any | 43 (0·6%) | 42 (0·6%) | 0·01 (−0·28 to 0·31) | 0·92 | 33 (0·4%) | 36 (0·4%) | −0·04 (−0·25 to 0·18) | 0·72 | 76 (0·5%) | 78 (0·5%) | −0·01 (−0·19 to 0·17) | 0·87 |
| Grade ≥3 | 3 (<0·1%) | 2 (<0·1%) | 0·01 (−0·06 to 0·09) | >0·99 | 11 (0·1%) | 9 (0·1%) | 0·02 (−0·09 to 0·14) | 0·66 | 14 (0·1%) | 11 (0·1%) | 0·02 (−0·05 to 0·09) | 0·55 |
| Serious adverse events during the safety observation period | ||||||||||||
| Any | 40 (0·6%) | 32 (0·5%) | 0·12 (−0·16 to 0·39) | 0·35 | 120 (1·4%) | 122 (1·4%) | −0·02 (−0·43 to 0·38) | 0·89 | 160 (1·0%) | 154 (1·0%) | 0·04 (−0·22 to 0·29) | 0·74 |
| Vaccination-related | 0 | 0 | NA | .. | 0 | 0 | NA | .. | 0 | 0 | NA | .. |
Data are n (%), unless otherwise stated. Any refers to all participants with any grade of adverse events or reactions. NA=not applicable.
*
Participants who received at least one dose of vaccine or placebo, based on actual administrations.