Johnson & Johnson’s subsidiary Janssen Biotech has submitted an Emergency Use Authorization (EUA) application to the US Food and Drug Administration (FDA) for its investigational single-dose Janssen Covid-19 vaccine candidate.
Once the authorisation is issued, Johnson & Johnson plans to immediately supply the vaccine to the US government, with 100 million doses to be distributed in the country in the first half of 2021.
Janssen Biotech’s EUA submission is based on the Phase 3 ENSEMBLE clinical trial’s topline efficacy and safety data, which validated the investigational single-dose vaccine’s claims of meeting all primary as well as key secondary endpoints.
The randomised, double-blind, Phase 3 ENSEMBLE study is a placebo-controlled clinical trial conducted in adults 18 years and above, and was designed to assess the efficacy and safety of the Janssen single-dose investigational vaccine against moderate and severe Covid-19.
Johnson & Johnson vice-chairman of the executive committee and chief scientific officer Paul Stoffels said: “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 authorisation 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.”
In accordance with it rolling out submissions to several health agencies outside the country, Johnson & Johnson will submit a conditional Marketing Authorisation Application (cMAA) with the European Medicines Agency soon.
The Janssen investigational vaccine, which leverages the company’s AdVac vaccine platform, is compatible with standard vaccine distribution channels. The AdVac vaccine platform was used to manufacture the EU-approved Ebola vaccine.
The single-dose, investigational vaccine is reckoned to stay stable for two years at a temperature of -4°F (or -20°C). Three months out of those 24 months can be used to store the vaccine in most standard refrigerators at 36°F-46°F (or 2°-8°C).
Shipping of the vaccine will be done via the usual cold chain technologies used for innovative medicines.