Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, will receive an additional commitment of up to $472 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, to support a larger Phase III study of mRNA-1273, the company’s mRNA vaccine candidate against COVID-19.

The additional funding follows an earlier award from BARDA of up to $482 million made in April (April 2020) to support the scale-up and clinical development of mRNA-1273, at which time Moderna had anticipated a smaller number of participants in a Phase III clinical trial. Following discussions with the US Food and Drug Administration (FDA) and consultations with Operation Warp Speed, a US government program that aims to accelerate the development of COVID-19 vaccines and treatments, the company decided to conduct a larger Phase III clinical trial, which left a gap in BARDA funding that will be now closed by this contract modification. The total value of the full award is now approximately $955 million.

Under the terms of the revised contract, BARDA is expanding its support of mRNA-1273 to include a 30,000-participant Phase III study in the US. The Phase III study has begun dosing participants and is being conducted in collaboration with National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, which began this week (July 27, 2020). The Phase III study protocol was reviewed by the FDA and is aligned to recent FDA guidance on clinical trial design for COVID-19 vaccine studies.

Moderna says it remains on track to be able to deliver approximately 500 million doses per year of its COVID-19 vaccine and possibly up to 1 billion doses per year, beginning in 2021, from its internal US manufacturing site and strategic collaboration with Lonza. In addition, Moderna recently announced a collaboration with Catalent for large-scale, commercial fill–finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Indiana. Moderna secured funding of $1.3 billion from its most recent public equity offering in May (May 2020) to support producing mRNA-1273 supply at risk.

Source: Moderna (BARDA agreement) and Moderna (Phase III study)