On Feb. 4, 2021, Johnson & Johnson announced that subsidiary Janssen Biotech, had submitted an application to the U.S. Food and Drug Administration requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate.

The Companyﾒs EUA submission was based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints.