The U.S. Department of Health and Human Services (HHS) and Department of Defense (DOD) inked a contract for up to $1.525 billion with Moderna to manufacture and deliver 100 million doses of the company’s COVID-19 vaccine candidate, according to press releases from HHS and Moderna.
Moderna will manufacture the vaccine doses, which the United States government will own, while clinical trials are underway. HHS said manufacturing in parallel with clinical trials expedites the traditional vaccine development timeline. 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 federal government also has provided funding for other vaccine candidates, including those from Janssen, part of Johnson & Johnson; AstraZeneca; a GlaxoSmithKline and Sanofi partnership; and Novavax.
The Moderna 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 (NIH). NIAID has continued to support the vaccine’s development including nonclinical studies and clinical trials.
A 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, according to HHS.
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 to provide the funding to manufacture and deliver the vaccine doses to government-designated locations across the country. The government also can acquire up to an additional 400 million doses of the vaccine.
BARDA already had provided up to $955 million for the development of mRNA-1273 up to licensure, according to Moderna.
