J&J Ad26.COV2.S COVID-19 vaccine gets FDA emergency use authorization

Johnson & Johnson (J&J) said that the US Food and Drug Administration (FDA) has given emergency use authorization (EUA) for Ad26.COV2.S, a single-dose COVID-19 vaccine developed by its subsidiary Janssen Pharmaceutical Companies for the prevention of COVID-19 in people aged 18 years or more.

The FDA decision was driven by the totality of scientific evidence. This included results from the phase 3 ENSEMBLE trial that showed the vaccine to be 85% effective in preventing severe disease across all the studied regions, while showing protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

Johnson & Johnson intends to submit a biologics license application (BLA) for the Ad26.COV2.S vaccine with the FDA later this year.

Alex Gorsky – Chairman and Chief Executive Officer at Johnson & Johnson said: “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.

“We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”

The Ad26.COV2.S COVID-19 vaccine uses the AdVac vaccine platform, which was also employed to develop and manufacture Janssen’s Ebola vaccine regimen that was approved in the European Union. The AdVac vaccine platform was also used for constructing Janssen’s investigational Zika, RSV, and HIV vaccines.

Recently, Johnson & Johnson submitted a conditional marketing authorisation application for the Ad26.COV2.S COVID-19 vaccine to the European Medicines Agency. Apart from that, the company also filed for an emergency use listing (EUL) with the World Health Organization for the COVID-19 vaccine candidate.

Paul Stoffels – Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson said: “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.

“We look forward to our continued efforts around the world as we collectively aim to change the trajectory of this global pandemic.”