Moderna on Thursday announced an agreement that will see the US Biomedical Advanced Research and Development Authority (BARDA) commit up to $483 million to accelerate development of the company’s mRNA vaccine candidate mRNA-1273 against SARS-CoV-2. The company stated that the funding will support late-stage clinical development programmes for mRNA-1273, as well as the scale up of manufacturing in 2020.
CEO Stéphane Bancel said that "by investing now in our manufacturing process scale-up to enable large-scale production for pandemic response, we believe that we would be able to supply millions of doses per month in 2020, and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic." To support the scale-up, Moderna indicated that it plans to hire up to 150 new team members in the US this year. This includes a "significant increase" in its skilled manufacturing staff, engineers to manage process scale-up, as well as clinical and regulatory staff to support clinical development.
Under the terms of the BARDA agreement, the US agency will fund the advancement of mRNA-1273 up to FDA licensure. A Phase I study of the vaccine candidate, which encodes for a prefusion-stabilised form of the spike protein on the coronavirus, began in mid-March and is being conducted by the US National Institutes of Health (NIH).
Moderna said enrollment of the original study is complete, with 45 healthy adult volunteers ages 18 to 55 years in three dose cohorts. However, the NIH recently amended the Phase I protocol to include an additional six cohorts, including three of older adults ages 51 to 70 years, and another three involving elderly adults ages 71 years and over. Enrollment for these cohorts is ongoing.
If the early-stage testing proves successful, Moderna said it intends to begin a Phase II study of mRNA-1273 in the second quarter of 2020, with a Phase III trial potentially getting underway "as soon as fall." BARDA director Rick Bright said the agency's goal is to have "vaccine available as quickly as possible, and preparing now for advanced-stage clinical trials and production scale-up while the Phase I is underway could shave months off development of COVID-19 vaccines."
Earlier this month, Inovio Pharmaceuticals said it also began a Phase I trial of its experimental DNA vaccine candidate INO-4800 designed to prevent COVID-19 infection. For additional analysis, see ViewPoints: COVID-19 vaccines in focus as well as ViewPoints: Moderna rolls out the red carpet for its vaccine aspirations.
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