Posted by Michael Wonder on 06 Feb 2021
Johnson & Johnson announces submission of application to the U.S. FDA for Emergency Use Authorisation of its investigational single shot Janssen COVID-19 vaccine candidate
4 February 2021 - Johnson & Johnson intends to distribute vaccine to the U.S. government immediately following authorisation, and expects to supply 100 million doses to the U.S. in the first half of 2021.
Johnson & Johnson today announced that Janssen Biotech, Inc., has submitted an application to the U.S. FDA requesting Emergency Use Authorisation (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate.
The Company’s EUA submission is based on top line efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary outcomes.
