Table 4.
Overall Unsolicited Treatment-Emergent Adverse Events Through 28 Days After Vaccination: Safety Analysis Set
| Participants, No. (%) | |||
|---|---|---|---|
| Parameter | NVX-CoV2515 (n = 286) | NVX-CoV2373 (n = 274) | Bivalent (n = 269) |
| Solicited TEAEs | |||
| Locala | 196 (69.3) | 193 (71.0) | 173 (64.6) |
| Grade ≥3 | 5 (1.8) | 1 (0.4) | 3 (1.1) |
| Systemicb | 176 (62.2) | 158 (58.1) | 166 (61.9) |
| Grade ≥3 | 21 (7.4) | 10 (3.7) | 8 (3.0) |
| Unsolicited TEAEs | |||
| Any | 98 (34.3) | 104 (38.0) | 91 (33.8) |
| Treatment related | 14 (4.9) | 8 (2.9) | 9 (3.3) |
| Severe | 0 | 4 (1.5) | 0 |
| Treatment related severe | 0 | 0 | 0 |
| Serious | 1 (0.3) | 1 (0.4) | 0 |
| Treatment related | 0 | 0 | 0 |
| Any unsolicited TEAE leading to | |||
| Vaccination discontinuation | 1 (0.3) | 1 (0.4) | 0 |
| Treatment related | 1 (0.3) | 0 | 0 |
| Study discontinuation | 0 | 1 (0.4) | 0 |
| Treatment related | 0 | 0 | 0 |
| Any unsolicited treatment-emergent MAAE | 14 (4.9) | 18 (6.6) | 13 (4.8) |
| Treatment related | 1 (0.3) | 0 | 0 |
| Treatment related serious | 0 | 0 | 0 |
| Severe | 0 | 3 (1.1) | 0 |
| Treatment related severe | 0 | 0 | 0 |
| Any unsolicited AESI | |||
| PIMMC | 0 | 1 (0.4) | 0 |
| Treatment related | 0 | 0 | 0 |
| Complications due to COVID-19 | 0 | 0 | 0 |
| Any myocarditis/pericarditis | 0 | 0 | 0 |
Participants in the safety analysis set are counted according to the treatment received to accommodate for treatment errors.
Abbreviations: AESI, adverse event of special interest; MAAE, medically attended adverse event; PIMMC, potentially immune-mediated medical condition; TEAE, treatment-emergent adverse event.
aSolicited local events included tenderness, pain, redness, and swelling.
bSolicited systemic events included fatigue, headache, muscle pain, malaise, joint pain, nausea/vomiting, and fever.