Johnson & Johnson (J&J) 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 top-line 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.
The Janssen investigational vaccine is compatible with standard vaccine distribution channels. If authorized, Janssen’s investigational 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 today to transport other innovative medicines.
The Janssen investigational COVID-19 vaccine leverages the Company’s AdVac vaccine platform, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen 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.
The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial in adults 18 years old and older. The study was designed to evaluate the safety and efficacy of the Janssen 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.
The trial, conducted in eight countries across three continents, includes a diverse and broad population.
Research and development activities for the investigational Janssen COVID-19 vaccine including the ENSEMBLE clinical 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, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201700018C, and in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services (HHS).
Janssen has worked with BARDA since 2015 on innovative solutions for influenza, chemical, biological, radiation and nuclear threats and emerging infectious diseases such as Ebola. In February 2020, Janssen and BARDA began work on the development of a COVID-19 vaccine based on Janssen’s AdVac technology.
