J&J single dose COVID-19 vaccine receives FDA emergency use authorization

Johnson & Johnson’s single dose COVID-19 vaccine has received its Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) to prevent COVID-19 in individuals 18 years of age and older.   

The vaccine was developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, and received authorization based on the totality of scientific evidence, including 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.

“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”

According to a company statement, J&J will look to make its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The company has begun shipping its COVID-19 vaccines to the U.S. government 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 U.S.

“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,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “A vaccine that protects against COVID-19, especially against the severe outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide.”

The company plans to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021. “The U.S. government will manage allocation and distribution of the vaccine in the U.S. This will be prioritized according to the populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP) guidelines,” the statement read.

In parallel, J&J 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.

“We are thankful for the efforts of all those who have volunteered to participate in our clinical trials, our scientists, collaborators, clinical trial sites and investigators. Through the combined commitment of everyone involved, we have been able to discover, develop and manufacture a single dose COVID-19 vaccine to protect people around the world,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. 

According to the company, 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).