Moderna announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) for an additional commitment of up to $472 million to support late stage clinical development including the expanded Phase III study of the Company’s mRNA 1273 (mRNA vaccine candidate) against COVID-19. An earlier award from BARDA for up to $483 million was entered into to support the scale up of mRNA 1273 and clinical development, originally with a smaller anticipated number of participants in the Phase III clinical trial. Following discussions with the FDA and consultations with Operation Warp Speed over the past several months, the Company has decided to conduct a significantly larger Phase III clinical trial, leaving a gap in BARDA funding that will be closed by this contract modification. Under the terms of the revised contract, BARDA is expanding their support of the Company’s late stage clinical development of mRNA 1273, including the execution of a 30,000 participant Phase III study in the U.S. The total value of the award is now approximately $955 million.
The Phase III COVE study is being conducted in collaboration with National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and is expected to begin tomorrow, July 27. The Phase III study protocol has been reviewed by the U.S. Food and Drug Administration (FDA) and is aligned to recent FDA guidance on clinical trial design for COVID-19 vaccine studies. The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants at the 100 µg dose level in the U.S. The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2.