WASHINGTON, DC - The Trump administration has ordered 100 million doses of a COVID-19 vaccine candidate to be manufactured by Moderna, Inc., an American biotech company focused on drug and vaccine discovery and development.
The federal government will own these vaccine doses, the Pentagon said in a statement on Tuesday.
Moderna will manufacture the vaccine doses while clinical trials are underway. Manufacturing in parallel with clinical trials expedites the traditional vaccine development timeline and builds toward the U.S. government's Operation Warp Speed goal to begin delivering safe and effective vaccines to the American people by the end of the year. If the U.S. 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, the Pentagon statement said.
"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," the U.S. Department of Health and Human Services (HHS) Secretary Alex Azar said Tuesday. "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."
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command to provide up to approximately $1.525 billion to manufacture and deliver the vaccine doses to government-designated locations across the country. The government can additionally acquire up to an additional 400 million doses of the vaccine.
Tuesday's award of up to $1.525 billion is for the manufacturing and delivery of 100 million doses of mRNA-1273 including incentive payments for timely delivery of the product. With a previous award of up to $955 million from BARDA for the development of mRNA-1273 to licensure, Tuesday's announcement brings the U.S. government commitments for early access to mRNA-1273 to up to $2.48 billion.
"We appreciate the confidence of the U.S. government in our mRNA vaccine platform and the continued support," Stphane Bancel, Moderna's Chief Executive Officer said Tuesday "We are advancing the clinical development of mRNA-1273 with the ongoing Phase 3 study being conducted in collaboration with NIAID and BARDA. In parallel, we are scaling up our manufacturing capability with our strategic partners, Lonza, Catalent and Rovi, to address this global health emergency with a safe and effective vaccine."
The project announced on Tuesday 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.
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. NIAID has continued to support the vaccine's development including nonclinical studies and clinical trials.
In addition, BARDA has supported phase 2/3 clinical trials, vaccine manufacturing scale up and other development activities for this vaccine. 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.