Table 3.
Clinical Outcomes and Adverse Events
| Outcomes | mRNA-1273 (Moderna) | BNT162b2 (Pfizer-BioNTech) | Total |
|---|---|---|---|
| Confirmed SARS-CoV-2 infection | 2/205c (1.0%; 0.0–2.3%) | 3/210c (1.4%; 0.0–3.0%) | 5/415c (1.2%; 0.2–2.3%) |
| Symptomatic | 2/205 (1.0%; 0.0–2.3%) | 1/210 (0.5%; 0.0–1.4%) | 3/415 (0.7%; 0.0–1.5%) |
| Asymptomatic | 0/205 (0.0%) | 2/210 (1.0%; 0.1–3.4%) | 2/415 (0.5%; 0.0–1.1%) |
| Severe COVID-19 infection | 0/205 (0.0%) | 0/210 (0.0%) | 0/415 (0.0%) |
| COVID-19 burden of diseasea (mean, SD) | 0.010 (0.099 SD) | 0.014 (0.118 SD) | 0.012 (0.109 SD) |
| Confirmed SARS-COV-2 infection of household members | 0/205 (0.0%) | 0/210 (0.0%) | 0/415 (0.0%) |
| Safety outcomes after first vaccine | |||
| Any local symptoms limiting continuation of normal daily activities during the first 7 days | 13/205 (6.3%; 3.0–9.7%) | 14/210 (6.7%; 3.3–10.0%) | 27/415 (6.5%; 4.1–8.9%) |
| Any systemic symptoms limiting continuation of normal daily activities during the first 7 days | 14/205 (6.8%; 3.4–10.3%) | 12/210 (5.7%; 2.6–8.9%) | 26/415 (6.3%; 3.9–8.6%) |
| Any vaccine related symptom leading to contacting a physician during the first 7 days | 2/205 (1.0%; 0.0–2.3%) | 1/210 (0.5%; 0.0–1.4%) | 3/415 (0.7%; 0.0–1.5%) |
| Safety outcomes after second vaccine | |||
| Any local symptoms limiting continuation of normal daily activities during the first 7 days | 18/202 (8.9%; 5.0–12.8%) | 13/205 (6.3%; 3.0–9.7%) | 31/407 (7.6%; 5.0–10.2%) |
| Any systemic symptoms limiting continuation of normal daily activities during the first 7 days | 44/202 (21.8%; 16.1–27.5%) | 22/205 (10.7%; 6.5–15.0%) | 66/407 (16.2%; 12.6–19.8%) |
| Any vaccine related symptom leading to contacting a physician during the first 7 days | 3/202 (1.5%; 0.0–3.2%) | 2/205 (1.0%; 0.0–2.3%) | 5/407 (1.2%; 0.2–2.3%) |
| Serious adverse eventsb | 9/205 (4.4%; 1.6–7.2%) | 9/210 (4.3%; 1.5–7.0%) | 18/415 (4.3%; 2.4–6.3%) |
| Patient died | 1/205 (0.5%; 0.0–1.4%) | 1/210 (0.5%; 0.0–1.4%) | 2/415 (0.5%; 0.0–1.1%) |
SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SD, standard deviation.
The burden of disease was judged as 0 for no SARS-CoV-2 infection, 1 for nonsevere SARS-CoV-2 infections and 2 for severe SARS-CoV-2 infections.
All infections occurred after the first vaccination, but before the second vaccine was administered.
All infections occurred after the first vaccination, but before the second vaccine was administered.