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Moderna Gets Additional $472 Mln From BARDA For COVID-19 Vaccine Development

Moderna, Inc. (MRNA) announced that it has received an additional $472 million from Biomedical Advanced Research and Development Authority (BARDA) to support Phase 3 study of the Company's mRNA-1273 against COVID-19.

In April, BARDA committed up to $483 million to accelerate the development of mRNA-1273 against the novel coronavirus.

Under revised terms, BARDA is expanding their support of late stage clinical development of mRNA-1273, including the execution of a 30,000 participant Phase 3 study in the U.S. The total value of the award is now approximately $955 million.

Following discussions with FDA and consultations with Operation Warp Speed over the past several months, the Company has decided to conduct a significantly larger Phase 3 clinical trial, leaving a gap in BARDA funding that will be closed by this contract modification.

The company specified that the Phase 3 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 3 study protocol has been reviewed by the U.S. 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 g dose level in the U.S.

The Company said it remains on track to be able to deliver about 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the Company's internal U.S. manufacturing site and strategic collaboration with Lonza.

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