HHS reaches agreement with Janssen Pharmaceuticals for COVID-19 vaccine candidate

The U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) struck a deal with the Janssen Pharmaceuticals, which is part of Johnson & Johnson, to demonstrate large-scale manufacturing and delivery of the company’s COVID-19 vaccine candidate.

As part of the agreement, the federal government will own the resulting 100 million doses of vaccine. The vaccine doses could be used in clinical trials or, if authorized by the U.S. Food and Drug Administration (FDA), distributed as part of a COVID-19 vaccination campaign. The government also can acquire additional doses to vaccinate 300 million people.

“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,” HHS Secretary Alex Azar said. “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.”

This manufacturing demonstration project will take place while clinical trials are underway, which expedites the traditional vaccine development timeline. It is part of the U.S. government’s Operation Warp Speed goal to begin delivering vaccines to the American people by the end of the year.

The Biomedical Advanced Research and Development Authority (BARDA), which is part of the HHS Office of the Assistant Secretary for Preparedness and Response, provides approximately $1 billion to support the manufacturing demonstration project.

To date, BARDA has provided approximately $456 million for clinical trials and other vaccine development activities through an existing partnership with Janssen.