The U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) announced an agreement with the Janssen Pharmaceutical Companies of Johnson & Johnson, to demonstrate large-scale manufacturing and delivery of the company’s COVID-19 vaccine candidate. Under the terms 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 the U.S. Food and Drug Administration (FDA) authorizes use as outlined in agency guidance, the doses would be distributed as part of a COVID-19 vaccination campaign.
“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,” said HHS Secretary Alex Azar. “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. Working in parallel this way expedites the traditional vaccine development timeline. This step builds toward the U.S. government’s Operation Warp Speed goal to begin delivering millions of doses of safe and effective vaccines to the American people by the end of the year.
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command, to provide approximately $1 billion to support the manufacturing demonstration project including the ability to deliver vaccine doses to government-designated locations across the country. The government also can acquire additional doses up to a quantity sufficient to vaccinate 300 million people.
The project announced today includes fill-finish manufacturing in U.S.-based facilities. This fill-finish manufacturing step ensures vaccine doses are packaged and ready to ship immediately, subject to successful clinical trials and FDA authorization.
If these doses are used in a COVID-19 vaccination campaign, the vaccine would be available to the American people at no cost. As is customary with government-purchased vaccines, healthcare professionals could charge for the cost of administering the vaccine.
To date, BARDA has provided approximately $456 million for clinical trials and other vaccine development activities under an existing, long-term partnership with Janssen. The company’s investigational vaccine relies on Janssen’s recombinant adenovirus technology, AdVac, a technology used to develop and manufacture Janssen’s Ebola vaccine with BARDA support; that vaccine received European Commission approval and was used in the Democratic Republic of the Congo (DRC) and Rwanda during the 2018-2020 Ebola outbreak that began in the DRC.
