Johnson Submits Application News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Friday, February 05, 2021
 
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Johnson & Johnson announced Thursday night that Janssen Biotech, Inc., has submitted an application to the U.S. 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 3 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 authorization.
On January 29, Johnson & Johnson announced that its single-shot coronavirus vaccine was 66% effective in protecting against moderate to severe COVID-19 disease in Phase 3 trials, which was comprised of nearly 44,000 participants across eight countries.GET THE LATEST BREAKING NEWS HERE SIGN UP FOR GOLOCAL FREE DAILY EBLAST ....

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