Johnson & Johnson (J&J) said that its subsidiary Janssen Pharmaceutical has agreed to manufacture and supply 100 million doses of its SARS-CoV-2 investigational vaccine Ad26.COV2.S to the US government, in a deal worth more than $1 billion.
The Janssen Covid-19 vaccine candidate will be supplied either after approval by the US Food and Drug Administration (FDA) or after getting an emergency use authorization.
The Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, in collaboration with the US Department of Defense, are representing the US government in this deal.
Alex Azar – US Department of Health and Human Services Secretary said: “With the portfolio of vaccines being assembled for Operation Warp Speed, the Trump Administration is increasing the likelihood that the United States will have at least one safe, effective vaccine by 2021.
“Today’s investment represents the next step in supporting Janssen’s vaccine candidate all the way through manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.”
Johnson & Johnson said that the Ad26.COV2.S vaccine candidate will be offered at a global not-for-profit basis for emergency use to address the coronavirus pandemic. The agreement also gives an option to the US government to buy an additional 200 million doses of the Janssen Covid-19 vaccine candidate under a subsequent deal.
Paul Stoffels – Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson said: “Johnson & Johnson’s global team of experts has worked tirelessly alongside BARDA and scientific partners to pursue a SARS-CoV-2 vaccine that can help to stop the spread of COVID-19.
“We greatly appreciate the U.S. government’s confidence in, and support for, our R&D platform and efforts and the scalability of our vaccine technology. We are scaling up production in the U.S. and worldwide to deliver a SARS-CoV-2 vaccine for emergency use.”
Currently, the Ad26.COV2.S Covid-19 vaccine candidate is undergoing a phase 1/2a clinical trial across the US and Belgium in humans based on its positive preclinical data.
The Janssen Covid-19 vaccine candidate utilizes its AdVac technology, which was also used for developing an Ebola vaccine that was approved by the European Commission and also for constructing the company’s HIV, RSV, and Zika vaccine candidates.