Table 1.
Outcomes Based on the Intention-to-Treat Dataset
| Outcomes | mRNA-1273 (Moderna) |
BNT162b2 (Pfizer-BioNTech) |
Total | Difference |
|---|---|---|---|---|
| Immune response (Elecsys S, cutoff ≥100 units/mL) | 95.3% (91.9%–98.7%); 142/149 | 98.1% (95.9%–100.0%); 151/154 | 96.7% (94.7%–98.7%); 293/303 | −2.8% (−6.8% to 1.3%) |
| Immune response (Elecsys S, cutoff ≥0.8 units/mL) | 96.6% (93.8%–99.5%); 144/149 | 98.7% (96.9%–100.0%); 152/154 | 97.7% (96.0%–99.4%); 296/303 | −2.1% (−5.5% to 1.3%) |
| Immune response (ABCORA 2) [11] | 96.0% (92.8%–99.1%); 143/149 | 98.0% (95.8%–100.0%); 149/152 | 97.0% (95.1%–98.9%); 292/301 | −2.1% (−5.9% to 1.8%) |
| Neutralization (ABCORA 2) [11], cutoff 17 | 92.6% (88.4%–96.8%); 138/149 | 96.7% (93.9%–99.6%); 147/152 | 94.7% (92.2%–97.2%); 285/301 | −4.1% (−9.2% to 1.0%) |
| Immunoglobulins, mean (95% CI) | ||||
| IgG RBD | 208.4 (195.7–221.1) | 202.4 (192.9–212.0) | 205.5 (197.5–213.5) | … |
| IgG S1 | 230.5 (214.7–246.3) | 220.2 (207.2–233.1) | 225.5 (215.2–235.7) | … |
| IgA S1 | 5.3 (4.8–5.8) | 5.765 (5.4–6.3) | 5.5 (5.2–5.9) | … |
| IgM S1 | 0.2 (.1–.2) | 0.2 (.1–.3) | 0.2 (.1–.2) | … |
| Clinical outcomesa | ||||
| Confirmed SARS-CoV-2 infection | 9.3% (4.6%–13.9%); 14/151 | 6.4% (2.6%–10.3%); 10/156 | 7.8% (4.8%–10.8%); 24/307 | … |
| Asymptomatic SARS-CoV-2 infection | 0.7% (0.0–2.0%); 1/151 | 0.6% (0.0–1.9%); 1/156 | 0.7% (0.0–1.6%); 2/307 | … |
| Symptomatic SARS-CoV-2 infection | 8.6% (4.1%–13.1%); 13/151 | 5.8% (2.1%–9.4%); 9/156 | 7.2% (4.3%–10.1%); 22/307 | … |
| Severe COVID-19 infectionb | 0.0% (0.0–0.0); 0/151 | 0.0% (0.0–0.0); 0/156 | 0.0% (0.0–0.0); 0/307 | … |
| Confirmed SARS-CoV-2 infection of household members | 4.6% (1.3%–8.0%); 7/151 | 5.1% (1.7%–8.6%); 8/156 | 4.9% (2.5%–7.3%); 15/307 | … |
| Serious adverse events | 0.7% (0.0–2.0%); 1/151 | 0.6% (0.0–1.9%); 1/156 | 0.7% (0.0–1.6%); 2/307 | … |
| Death | 0.0% (0.0–0.0); 0/151 | 0.0% (0.0–0.0); 0/156 | 0.0% (0.0–0.0); 0/307 | … |
| Safety outcomesc | ||||
| Any symptoms at injection site limiting continuation of normal daily activities during the first 7 d following third vaccination | 7.3% (3.2%–11.5%); 11/150 | 5.8% (2.1%–9.4%); 9/156 | 6.5% (3.8%–9.3%); 20/306 | … |
| Any systemic symptoms (e.g. fever, muscle pain, joint pain) limiting continuation of normal daily activities during the first 7 d following third vaccination | 13.3% (7.9%–18.8%); 20/150 | 7.1% (3.0%–11.7%); 11/156 | 10.1% (6.7%–13.5%); 31/306 | … |
| Any vaccine-related symptoms leading to consultation 7 d following third vaccination | 1.3% (0.0–3.2%); 2/150 | 0.0% (0.0–0.0); 0/156 | 0.7% (0.0–1.6%); 2/306 | … |
Abbreviations: CI, confidence interval; COVID-19, coronavirus disease 2019; IgA, immunoglobulin A; IgG, immunoglobulin G; IgM, immunoglobulin M; RBD, receptor-binding domain; S1, S1 subunit of the spike protein; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
a
Clinical outcomes: 5 missing.
b
Safety outcomes: 9 missing.
c
Symptoms leading to hospitalization.