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Through the agreement, BARDA will support the advancement of the vaccine candidate to FDA licensure and will handle all late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020.
Moderna, a clinical stage biotechnology company headquartered in Cambridge, MA, announced on April 16, 2020 that the Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Department of Health and Human Services, has awarded them up to $483 million to accelerate development of its messenger RNA (mRNA) vaccine candidate (mRNA-1273) against COVID-19.
Through the agreement, BARDA will support the advancement of mRNA-1273 to FDA licensure and will handle all late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020, a Moderna press release said. Currently, a Phase 1 study of the vaccine is being conducted by the National Institutes of Health and, if successful, Moderna plans to launch a Phase 2 study during the second quarter of 2020 and a potential Phase 3 study in fall 2020.
“We are thankful for BARDA’s support to fund the accelerated development of mRNA-1273, our vaccine candidate against SARS-CoV-2,” said Stéphane Bancel, Moderna’s CEO, in the press release. “Time is of the essence to provide a vaccine against this pandemic virus. 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.”
“Vaccines are a critical tool for saving lives and stopping the spread of the SARS-CoV-2 virus,” added Rick Bright, director of BARDA, in the press release. “Delivering a safe and effective vaccine for a rapidly spreading virus requires accelerated action. BARDA’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 1 is underway could shave months off development of COVID-19 vaccines.”