Table 3.
Adverse events
| CVnCoV | Placebo | ||
|---|---|---|---|
| Any solicited adverse event* | |||
| Overall | 1933/2003 (96·5%) | 1344/1978 (67·9%) | |
| Grade 3 | 542/2003 (27·1%) | 61/1978 (3·1%) | |
| Local | 1699/2003 (84·8%) | 477/1978 (24·1%) | |
| Grade 3 | 25/2003 (1·2%) | 1/1978 (<0·1%) | |
| Systemic | 1881/2003 (93·9%) | 1255/1978 (63·4%) | |
| Grade 3 | 536/2003 (26·8%) | 60/1978 (3·0%) | |
| Any unsolicited adverse event* | |||
| Overall | 1010/2007 (50·3%) | 898/1987 (45·2%) | |
| Grade 3 | 45/2007 (2·2%) | 38/1987 (1·9%) | |
| Considered vaccination-related | 510/2007 (25·4%) | 268/1987 (13·5%) | |
| Any serious adverse event† | |||
| Overall | 82/19 783 (0·4%); 100 | 66/19 746 (0·3%); 76 | |
| Considered vaccination-related | 5/19 783 (<0·1%); 8 | 2/19 746 (<0·1%); 2 | |
| Any adverse event of special interest† | |||
| Overall | 38/19 783 (0·2%); 44 | 31/19 746 (0·2%); 35 | |
| Considered vaccination-related | 14/19 783 (0·1%); 18 | 5/19 746 (<0·1%); 6 | |
| Any adverse event with fatal outcome† | |||
| Overall | 8/19 783 (<0·1%) | 6/19 746 (<0·1%) | |
| Considered vaccination-related | 0 | 0 | |
Data are n/N (%) or n/N (%); number of events. Serious adverse events are reported from immediately after the second dose to the date of data cutoff (June 18, 2021).
Solicited and unsolicited adverse events were analysed in the reactogenicity analysis set, which comprised participants in the phase 2b trial who received at least one dose of CVnCoV or placebo and and for whom at least one diary entry reporting the presence or absence of a solicited adverse event was available (phase 2b reactogenicity) and all participants who had received at least one dose of CVnCoV or placebo (phase 2b safety). In the phase 2b part of the study, solicited local and systemic adverse events were reported in participant diaries for 7 days following any dose and unsolicited adverse events were reported in participant diaries for 28 days following any dose.
Serious adverse events and adverse events of special interest or with a fatal outcome were analysed in the phase 2b–3 safety analysis set, which comprised all participants who received at least one dose of CVnCoV or placebo; participants were analysed in the group corresponding to the dose they actually received.