Johnson & Johnson has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorisation for its single-dose Janssen COVID-19 vaccine candidate.
Johnson & Johnson intends to distribute 100 million doses to the U.S. in the first half of 2021, starting immediately on FDA approval.
The vaccine is 85% effective in preventing severe forms of COVID-19. The efficacy of the treatment increased over time, the company said, with no cases in vaccinated participants after 49 days.
"Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible,," said Paul Stoffels, Chief Scientific Officer at Johnson & Johnson.