Table 2.
Main characteristics of adverse events following vaccination
| Groups |
Total (%) | ||
|---|---|---|---|
| Vaccine (%) | Placebo (%) | ||
| N | 708 | 102 | 810 |
| Subjects with some AEs | 336 (47.5) | 24 (23.5) | 360 (44.4) |
| Subjects with some VAAEs | 311 (43.9) | 16 (15.7) | 327 (40.4) |
| Subjects with some serious AEs | 4 (0.5) | 1 (1.0) | 5 (0.6) |
| Subjects with some serious VAAEs | 1 (0.1) | – | 1 (0.1) |
| Subjects with some severe AEs (no VAAEs) | 1 (0.1) | – | 1 (0.1) |
| Total AEs | 899 | 48 | 947 |
| Mild AEs | 831 (92.4) | 4 (95.8) | 877 (92.6) |
| Moderate AEs | 66 (7.3) | 2 (2.2) | 68 (7.2) |
| Severe AEs | 2 (0.2) | – | 2 (0.2) |
| Serious AEs | 7 (0.8) | 1 (2.1) | 8 (0.8) |
| Local AEs | 583 (64.8) | 12 (25.0) | 595 (62.8) |
| Systemic AEs | 316 (35.2) | 36 (75.0) | 352 (37.2) |
| VAAEs | 706 (78.5) | 26 (54.2) | 732 (77.3) |
| Serious VAAEs | 1 (0.1) | 0 (0.0) | 1 (0.1) |
| Severe VAAEs | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Reported serious AEs (VAAEs) | multiform erythema | – | – |
Vaccine = heterologous scheme (SOBERANA 02 two doses + SOBERANA Plus). Vaccine data correspond to results from participants vaccinated with both API batches. Data are n (%). AE, adverse event; VAAE, vaccine-associated adverse event.