Vaccine composition• Recombinant, replication-incompetent adenovirus type 26 (Ad26) vectored • Encodes SARS-CoV-2 spike (S) protein • Produced in PER.C6 cells
Dosing regimenIntramuscular, single-dose regimen 5x10 10 vp Proposed indication and usage under EUA For active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older 18 to <60 years without comorbidities 18 to <60 years with and without comorbidities ≥60 years without comorbidities ≥60 years with and without comorbidities Goal of 30% of total study population • Planned study duration: 2 years Study 3001 Scheduled Visits and Assessments Day 1 Vaccination Blood Sample Nasal Sample Day 29 Blood Sample Day 71 Blood Sample Months 6 and 12 Blood Sample Months 18 and 24 Blood Sample Primary analysis: January 22, 2021 Median follow-up: 58 Days Subgroup Ad26.COV2.S Placebo All Subjects Ethnicity Hispanic or Latino 8793 (44.8%) 8936 (45.4%) 17729 (45.1%) Not Hispanic or Latino 10344 (52.7%) 10259 (52.1%) 20603 (52.4%) Unknown 493 (2.5%) 496 (2.5%) 989 (2.5%) Country Brazil 3399 (17.3%) 3390 (17.2%) 6789 (17.3%) Chile 531 (2.7%) 540 (2.7%) 1071 (2.7%) Argentina 1402 (7.1%) 1414 (7.2%) 2816 (7.2%) Colombia 1858 (9.5%) 1869 (9.5%) 3727 (9.5%) Peru 571 (2.9%) 581 (3.0%) 1152 (2.9%) Mexico 206 (1.0%) 220 (1.1%) 426 (1.1%) United States 9185 (46.8%) 9171 (46.6%) 18356 (46.7%) South Africa 2478 (12.6%) 2506 (12.7%) 4984 (12.7%) Presence of baseline comorbidity One or more 7830 (39.9%) 7867 (40.0%) 15697 (39.9%) None 11800 (60.1%) 11824 (60.0%) 23624 (60.1%)
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