J&J files for EUA on single-shot Janssen COVID-19 vaccine candidate

Janssen Biotech has submitted an application to the US 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 top-line efficacy and safety data from the Phase III ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints and had a strong rate of preventing infections. Janssen, part of US healthcare giant Johnson & Johnson (NYSE: JNJ), 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 Dr Paul Stoffels, chief scientific 0fficer 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,” he noted.