Moderna is working toward U.S. Food and Drug Administration (FDA) licensure on an mRNA vaccine for SARS-CoV-2 — the virus that causes COVID-19 — with a $483 million award from the Biomedical Advanced Research and Development Authority (BARDA).
“Vaccines are a critical tool for saving lives and stopping the spread of the SARS-CoV-2 virus,” BARDA Director Rick Bright said. “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.”
The vaccine, named mRNA-1273, is currently engaged in a Phase 1 study led by the National Institutes of Health (NIH). The study has enrolled three dose cohorts, with current moves underway to include a further six groups of older and elderly adults. In all, 45 adult volunteers between 18 and 55 years old are currently engaged in the study. The future enrollees will include those between ages 51-70 and age 71 and above.
“We are thankful for BARDA’s support to fund the accelerated development of mRNA-1273, our vaccine candidate against SARS-CoV-2,” Moderna CEO Stéphane Bancel said. “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.”
Supposing safety data from Phase 1 support moving forward, Moderna intends to begin a Phase 2 study as part of its own Investigational New Drug application in 2020’s second quarter. This would be followed by a Phase 3 study, which could begin as early as this fall. BARDA funding will help move all of these forward, along with a scale-up of manufacturing to enable large-scale production by year’s end.
The company will also hire as many as 150 new team members to support these efforts. These will include manufacturing staff, engineers, and clinical and regulatory staff.