NEW BRUNSWICK, NJ—Johnson & Johnson recently stated that Janssen Biotech has submitted an application to the FDA, requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The EUA submission is based on topline efficacy and safety data from the company’s Phase 3 ENSEMBLE clinical trial, which has demonstrated that the investigational single-dose vaccine met all primary and key secondary endpoints. Johnson & Johnson says that the company expects to have product available to ship immediately, following authorization.
“[The] 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,” explained Dr. Paul Stoffels, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson. “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.”
Johnson & Johnson has initiated rolling submissions with several health agencies outside the US, and will submit a Conditional Marketing Authorization Application with the European Medicines Agency in the coming weeks.
The Janssen investigational vaccine is compatible with standard vaccine distribution channels. If authorized, the investigational single-dose vaccine is estimated to remain stable for two years at -4°F (-20°C), and the vaccine can be stored for at least three months at standard refrigerators at temperatures of 36°F–46°F (2°-8°C). Johnson & Johnson will be able to ship the vaccine using the same cold chain technologies it generally uses to transport other medicines.
Janssen’s COVID-19 vaccine was created using Johnson & Johnson’s AdVac vaccine platform, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen. The platform has additionally been used to construct the company’s investigational Zika, RSV, and HIV vaccines. The safety profile observed for the COVID-19 vaccine was consistent with other investigational vaccines using the AdVac technology.
Research and development activities for the investigational Janssen COVID-19 vaccine, including the ENSEMBLE clinical trial and the delivery of doses for the US, has been funded in whole or in part by federal funds from the US Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, in collaboration with the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health.