Johnson & Johnson Announces Submission of Application to the FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate

Johnson & Johnson announced 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.

“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,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “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.”

The Company has initiated rolling submissions with several health agencies outside the U.S., and will submit a Conditional Marketing Authorisation Application (cMAA) with the European Medicines Agency in the coming weeks.