N.J.’s Johnson & Johnson files application with FDA for emergency approval of single-dose COVID-19 vaccine

New Brunswick-based company Johnson & Johnson announced on Thursday that Janssen Biotech, Inc. has submitted an application to the U.S. Food and Drug Administration requesting emergency use authorization for its investigational single-dose Janssen COVID-19 vaccine candidate.

The company’s submission is based on efficacy and safety data from a phase 3 ensemble clinical trial.

According to Johnson & Johnson data from the trial, the vaccine was 72% effective in the U.S. and 66% effective overall at preventing moderate to severe COVID-19, 28 days after vaccination. According to the company, the vaccine is 85% effective overall in preventing severe disease and demonstrated complete protection against COVID-19 related hospitalization and death 28 days after vaccination.

The company expects to have vaccine doses available to ship immediately following FDA authorization.

“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,” said Doctor Paul Stoffels, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson.

Janssen’s investigational single-dose vaccine is estimated to remain stable for two years at -4 degrees and can be stored for at least three months in most standard refrigerators at temperatures of between 36 and 46 degrees. The company plans to ship the vaccine using the same cold chain technologies it uses today to transport other medicines.

The phase 3 ensemble study was 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 an assessment of efficacy on day 14 and day 28 after subjects received the vaccine. The trial was conducted in eight countries across three continents.