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A sign marks an entrance to a Moderna, Inc., building, Monday, May 18, 2020, in Cambridge, Mass. Moderna announced Monday, May 18, 2020, that an experimental vaccine against the coronavirus showed encouraging results in very early testing, triggering hoped-for immune responses in eight healthy, middle-aged volunteers.(AP Photo/Bill Sikes)

Moderna expands Phase-3 clinical trial of its Covid-19 vaccine

New York – Pharmaceutical company Moderna has received an additional $472 million award from the US government’s Biomedical Advanced Research and Development Authority (BARDA) ahead of the expanded Phase-3 clinical trial of its Covid-19 vaccine candidate beginning yesterday.
The expanded Phase-3 study of the company’s mRNA vaccine candidate (mRNA-1273) against Covid-19 will include 30,000 participants, Moderna said recently.
An earlier award from BARDA for up to $483 million was entered into to support the scale up of the Covid-19 vaccine candidate and clinical development, originally with a smaller anticipated number of participants in the Phase-3 clinical trial.
The additional funding was needed to meet the requirements of the company’s late stage clinical development of mRNA-1273, including the execution of the larger Phase 3 study in the US. The total value of the award is now approximately $955 million, Moderna said.
“We thank BARDA for this continued commitment to mRNA-1273, our vaccine candidate against Covid-19,” said Moderna’s Chief Executive Officer Stephane Bancel.
“Encouraged by the Phase 1 data, we believe that our mRNA vaccine may aid in addressing the COVID-19 pandemic and preventing future outbreaks.”
The Phase 3 COVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).
Moderna said it remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the company’s internal US manufacturing site and strategic collaboration with Swiss drugmaker Lonza.
In addition, Moderna recently announced a collaboration with US-based Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Indiana.
Initial funding of $1.3 billion for Moderna to begin producing mRNA-1273 supply at-risk was secured from investors in the company’s most recent public equity offering in May this year.

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