Johnson & Johnson applies for FDA Emergency Use Authorization of Janssen COVID-19 vaccine

Following efficacy and safety data reports released earlier, Johnson & Johnson announced today that Janssen Biotech, Inc. — J&J’s pharmaceutical arm — has applied for Emergency Use Authorization from the United States Food and Drug Administration (FDA) for its COVID-19 vaccine candidate.

The Janssen COVID-19 vaccine is an investigational, single-dose candidate that met all its primary and key secondary endpoints last week. The results of a phase three trial put its overall efficacy at preventing moderate to severe COVID-19 cases at 66 percent for up to 28 days after vaccination, but 85 percent effective at preventing severe cases and 100 percent effective in preventing hospitalization.

“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,” Dr. Paul Stoffels, vice chairman of the executive committee and Chief Scientific Officer at J&J, said. “Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping.”

The company intends to begin shipping up to 100 million doses throughout the U.S. in the first half of 2021, following authorization. The vaccine can maintain stability for two years at -4 degrees Fahrenheit. However, it can be stored for three months at standard refrigerator temperatures, giving it improved storage and shipment capabilities over some other vaccines.

Rolling submissions with several health agencies outside the United States have already begun, and a Conditional Marketing Authorization Application with the European Medicines Agency is expected soon.