The Department of Health and Human Services (HHS) and Department of Defense (DoD), will purchase an additional 100 million doses of COVID-19 vaccine candidate, called mRNA-1273, from Moderna, according to a press release from HHS.
If authorized by the U.S. Food and Drug Administration through emergency use authorization, which Moderna has filed with the agency, HHS said doses of the vaccine will begin shipping immediately.
Under the agreement, Moderna will leverage its U.S.-based manufacturing capacity to fill, finish and ship vials of mRNA-1273 as the bulk material is produced. The additional doses ordered provide for continuous delivery through the end of June 2021, accelerating the delivery schedule for all 200 million doses the U.S. government is purchasing, HHS said.
Moderna began manufacturing the first 100 million doses while clinical trials were getting underway
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, has now collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command to provide up to approximately $3.2 billion to expand the manufacturing capacity reserved for mRNA-1273 and to deliver the vaccine doses to government-designated locations across the country. This federal funding brings the total provided to Moderna for this vaccine, including vaccine development, clinical trials and manufacturing, to $4.1 billion. The government also has the option to acquire up to an additional 300 million doses of the Moderna vaccine.
The vaccine candidate was co-developed by Moderna and scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, with NIAID also supporting the vaccine’s nonclinical studies and clinical trials. BARDA 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, was the first government-funded Phase 3 clinical trial for a COVID-19 vaccine in the U.S. and enrolled approximately 30,000 adult volunteers who did not have COVID-19. An independent data safety monitoring board overseeing the Phase 3 clinical trial reviewed the trial data and concluded that the vaccine was safe, prevented disease in 94 percent of the volunteers who received the vaccine and was generally well tolerated. The clinical studies are ongoing.
Moderna is the second company to apply for FDA emergency use authorization of a coronavirus vaccine that uses messenger RNA (mRNA), and FDA has scheduled a Vaccines and Related Biological Products Advisory Committee meeting Dec. 17 to review the company’s request.
Messenger RNA vaccines take advantage of the process that cells use to make proteins in order to trigger an immune response and build immunity to a virus. In contrast, most vaccines use weakened or inactivated versions or components of a disease-causing virus to stimulate the body’s immune response to create antibodies.
