J&J submits COVID-19 vaccine data to FDA for emergency authorisation 10 J&J have submitted Phase III trial data in their application to the FDA for emergency authorisation of their COVID-19 vaccine candidate. Johnson & Johnson (J&J) has announced that Janssen has submitted an application to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The company’s EUA submission is based on topline efficacy and safety data from the Phase III ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints. The company expects to have product available to ship immediately following authorisation.