HHS and DoD announced the agreement with Janssen Pharmaceutical, as the J&J subsidiary is set to offer large-scale manufacturing and the delivery of its COVID-19 vaccine candidate, with the federal government owning 100 million doses of the vaccine.
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS the DoD to provide approximately $1 billion to support the manufacturing project, which includes the delivery of vaccine doses to government-designated locations across the country. The government also can acquire additional doses in an effort to vaccinate up to 300 million people.
According to a news release, the vaccine doses could be used in clinical trials, or, if the FDA authorizes the vaccine, they could be distributed as part of a COVID-19 vaccination campaign.
Manufacturing is slated to take place while clinical trials are underway to expedite the traditional vaccine development timeline under the efforts of the government’s “Operation Warp Speed” which has set out to begin delivering safe vaccines to Americans by the end of 2020.
The deal with J&J’s Janssen includes fill-finish manufacturing in U.S.-based facilities to ensure that vaccine doses are packaged and ready to ship immediately once clinical trials and regulatory authorization are successful.
As part of a vaccination campaign, the vaccine would be available to Americans at no cost, although healthcare professionals could charge for the cost of administering the vaccine.
“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 in the release. “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.”