Johnson & Johnson COVID-19 Vaccine Becomes First Single-Shot Vaccine to Receive FDA Emergency Use Authorization

Johnson & Johnson’s (New Brunswick, NJ, USA) single-dose COVID-19 vaccine, developed by its Janssen Pharmaceutical Companies (Beerse, Belgium), has become the first single-shot vaccine to be granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA).

The FDA’s decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85% 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 Johnson & Johnson COVID-19 single-dose 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 vaccine is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas. 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 today to transport treatments for cancer, immunological disorders and other medicines.

Johnson & Johnson is committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The company has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the US. The company plans to deliver 100 million single-shot vaccines to the US during the first half of 2021. Johnson & Johnson also recently announced its submission of a European Conditional Marketing Authorization Application to the European Medicines Agency as well as its filing for an Emergency Use Listing (EUL) with the World Health Organization for its COVID-19 vaccine candidate. In addition, rolling submissions for the single-dose COVID-19 vaccine candidate have been initiated in several countries worldwide.

“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants. A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “We look forward to our continued efforts around the world as we collectively aim to change the trajectory of this global pandemic.”

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