By R. Mitchell –
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.
About Operation Warp Speed
OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
About HHS, ASPR, and BARDA:
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, BARDA-supported products have achieved 55 FDA approvals, licensures or clearances. To learn more about federal support for the nationwide COVID-19 response, visit coronavirus.gov.
About the JPEO-CBRND:
The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.
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Author: R. Mitchell
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