Johnson and Johnson submit an application to the US FDA

Johnson and Johnson has submitted an application to the US FDA, who’s seeking emergency use authorisation, for its investigational single-dose Janssen COVID-19 vaccine candidate. Based on topline efficiency and safety evidence from the Phase III ENSEMBLE clinical trial, the EUA submission shows that the investigational single-dose vaccine met both primary and secondary endpoints. Johnson and Johnson expect to have stock ready to distribute, following authorisation.

M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, Paul Stoffels, stated: “Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic. 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.”