Table 3.
Solicited local and systemic adverse events reported within 7 days after administration of BBV154 or Covaxin.
| [m events] in n participants (%) | ||
|---|---|---|
| Adverse events | BBV154 (N = 2989) | Covaxin® (N = 161) |
| Overall | [240] 205 (6.9%) | [51] 41 (25.5%) |
| Injection site pain | [0] 0 (0.0%) | [30] 27 (16.8%) |
| Injection site erythema | [0] 0 (0.0%) | [5] 5 (3.1%) |
| Injection site swelling | [0] 0 (0.0%) | [6] 6 (3.7%) |
| Lacrimation increased | [1] 1 (0.0%) | [0] 0 (0.0%) |
| Nasal congestion | [6] 6 (0.2%) | [0] 0 (0.0%) |
| Oropharyngeal pain | [16] 16 (0.5%) | [0] 0 (0.0%) |
| Rhinalgia | [15] 15 (0.5%) | [0] 0 (0.0%) |
| Rhinorrhoea | [79] 78 (2.67%) | [0] 0 (0.0%) |
| Sneezing | [42] 41 (1.4%) | [0] 0 (0.0%) |
| Chills | [1] 1 (0.0%) | [0] 0 (0.0%) |
| Fatigue | [4] 4 (0.1%) | [0] 0 (0.0%) |
| Headache | [47] 44 (1.5%) | [1] 1 (0.6%) |
| Myalgia | [7] 7 (0.2%) | [0] 0 (0.0%) |
| Nausea | [2] 2 (0.1%) | [2] 2 (1.2%) |
| Pyrexia | [17] 18 (0.6%) | [6] 5 (3.1%) |
| Vomiting | [2] 2 (0.1%) | [1] 1 (0.6%) |
m = No. of adverse events.
n = No. of participants and % is percentage of participants with the adverse event in respective treatment group.