Johnson & Johnson’s Janssen Biotech, Inc., submitted an application to the U.S. FDA requesting Emergency Use Authorization for its investigational single-dose Janssen COVID-19 vaccine candidate. The submission is based on efficacy and safety data from the Phase 3 ENSEMBLE trial demonstrating the investigational single-dose vaccine met all primary and key secondary endpoints. The company expects to have product available to ship immediately following authorization.

The Phase 3 ENSEMBLE study was designed to evaluate the safety and efficacy of the investigational vaccine in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints.

Among all participants from different geographies and including those infected with an emerging viral variant, Janssen’s COVID-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the U.S., 66% in Latin America, and 57% in South Africa, 28 days post-vaccination.

The investigational vaccine leverages the company’s AdVac vaccine platform, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine and construct its investigational Zika, RSV, and HIV vaccines. The safety profile observed was consistent with other investigational vaccines using Janssen’s AdVac technology among more than 200,000 people to date.

Manufacturing and Supply Chain
The Janssen investigational vaccine is compatible with standard vaccine distribution channels. If authorized, the single-dose vaccine is estimated to remain stable for two years at -4°F (-20°C), at least three months of which can be stored in most standard refrigerators at temperatures of 36°F–46°F (2°-8°C). The company will ship the vaccine using the same cold chain technologies it uses to transport other medicines.

R&D for the investigational Janssen COVID-19 vaccine including the ENSEMBLE trial and the delivery of doses for the U.S. has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA), and in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID).