Johnson & Johnson Applies for Emergency Use Authorization from FDA for Single-Shot COVID-19 Vaccine Candidate

Johnson & Johnson announced that Janssen Biotech, Inc has submitted an application to the FDA requesting Emergency Use Authorization (EUA) for its investigational single-dose coronavirus disease 2019 (COVID-19) vaccine candidate, according to a press release.

The EUA submission is based on topline efficacy and safety data from the phase 3 ENSEMBLE clinical trial, with the single-dose vaccine meeting all primary and secondary endpoints. The company expects to have product available to ship immediately following authorization.

The phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial in adults 18 years of age 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, with assessment of efficacy as of day 14 and day 28 as co-primary endpoints, according to the press release.

“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, MD, vice chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, in a press release. “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 investigational vaccine is compatible with standard vaccine distribution channels. If authorized, the vaccine is estimated to remain stable for 2 years at -4°F (-20°C), at least 3 months of which can be stored in most standard refrigerators at temperatures of 36°F—46°F (2°-8°C). Following this, the company will ship the vaccine using the same cold chain technologies it currently uses to transport other innovative medicines.

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

REFERENCE

Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate. Johnson and Johnson. https://www.jnj.com/johnson-johnson-announces-submission-of-application-to-the-u-s-fda-for-emergency-use-authorization-of-its-investigational-single-shot-janssen-covid-19-vaccine-candidate. Published February 4, 2021. Accessed February 5, 2021.