Johnson & Johnson’s Janssen Biotech, Inc., submitted an application to the U.S. FDA requesting Emergency Use Authorization for its investigational single-dose Janssen COVID-19 vaccine candidate. The submission is based on efficacy and safety data from the Phase 3 ENSEMBLE trial demonstrating the investigational single-dose vaccine met all primary and key secondary endpoints. The company expects to have product available to ship immediately following authorization. The Phase 3 ENSEMBLE stu...