To learn more about federal support for the nationwide COVID-19 response, visit. To date, BARDA-supported products have achieved 55 FDA approvals, licensures or clearances. 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. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. 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. 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. The Phase 3 clinical trial, which began July 27, is the first government-funded Phase 3 clinical trial for a COVID-19 vaccine in the United States. In addition, BARDA has supported phase 2/3 clinical trials, vaccine manufacturing scale up and other development activities for this vaccine. NIAID has continued to support the vaccine’s development including nonclinical studies and clinical trials. The vaccine, called mRNA-1273, has been co-developed by Moderna and scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. As is customary with government-purchased vaccines, healthcare professionals could charge for the cost of administering the vaccine. If these doses are used in a COVID-19 vaccination campaign, the vaccine would be available to the American people at no cost. This fill-finish manufacturing step ensures vaccine doses are packaged and ready to ship immediately, subject to successful clinical trials and FDA authorization. The project announced today includes fill-finish manufacturing in U.S.-based facilities. The government also can acquire up to an additional 400 million doses of the vaccine. 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 up to approximately $1.5 billion to manufacture and deliver the vaccine doses to government-designated locations across the country. “Today’s investment represents the next step in supporting this vaccine candidate all the way from early development by Moderna and the National Institutes of Health, through clinical trials, and now large-scale manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.” “In creating a vaccine portfolio 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. Food and Drug Administration (FDA) authorizes use as outlined in agency guidance, the vaccine doses would be distributed and used as part of a COVID-19 vaccination campaign. government’s Operation Warp Speed goal to begin delivering safe and effective vaccines to the American people by the end of the year. Manufacturing in parallel with clinical trials expedites the traditional vaccine development timeline and builds toward the U.S. Moderna will manufacture the vaccine doses while clinical trials are underway. The federal government will own these vaccine doses. to manufacture and deliver 100 million doses of the company’s COVID-19 vaccine candidate. Department of Health and Human Services (HHS) and Department of Defense (DoD) today announced an agreement with Moderna, Inc. Under the leadership of President Trump, the U.S.
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