Johnson & Johnson received Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies, to prevent COVID-19 in individuals 18 years of age and older.
 
This decision was based on data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.
 
The terms of the EUA allow use of the vaccine while more data are gathered. The company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.
 
The company began shipping its COVID-19 vaccines to the U.S. government and expects to deliver more than 20 million by the end of March, with plans to deliver 100 million vaccines during the 1H21.
 
The vaccine leverages the AdVac vaccine platform, a unique and proprietary technology that 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 AdVac technology works by using an adenovirus as a vector (a carrier) of an antigen’s genetic code, to mimic components of a pathogen (a bacterium, virus, or other disease-causing organism). Antigens (components of a pathogen) are produced to mimic the pathogen, without causing severe disease.

The single-dose vaccine is compatible with standard vaccine storage and distribution channels. The vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration at temperatures of 36-46°F (2 to 8°C). The company will ship the vaccine using the same cold chain technologies it uses to transport treatments for cancer, immunological disorders and other medicines.