Moderna, US Government Collaborate on Producing 100 Million COVID-19 Vaccine Doses

US government has purchased this batch of vaccines, which Moderna will manufacture concurrently with its phase 3 trials.

The US government announced yesterday it has purchased 100 million doses of Moderna’s mRNA-1273, its COVID-19 vaccine candidate, which the company will manufacture while it is undergoing its clinical trials.

Moderna’s vaccine is currently in phase 3, and by manufacturing in parallel with clinical trials it is expected to expedite the traditional vaccine development timeline and builds toward the US government’s Operation Warp Speed goal to begin delivering safe and effective vaccines to the American people by the end of the year.

“Today’s investment represents the next step in supporting this vaccine candidate all the way from early development by Moderna and the National Institutes of Health, through clinical trials, and now large-scale manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people,” Health and Human Services Secretary Alex Azar said.

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command to provide up to approximately $1.5 billion to manufacture and deliver the vaccine doses to government-designated locations across the country. The government also can acquire up to an additional 400 million doses of the vaccine.

Yesterday’s award of up to $1.525 billion is for the manufacturing and delivery of 100 million doses of mRNA-1273 including incentive payments for timely delivery of the product. With the previous award of up to $955 million from BARDA for the development of mRNA-1273 to licensure, this brings the US government commitments for early access to mRNA-1273 to up to $2.48 billion.

“We appreciate the confidence of the US government in our mRNA vaccine platform and the continued support,” Moderna CEO Stéphane Bancel said. “We are advancing the clinical development of mRNA-1273 with the ongoing Phase 3 study being conducted in collaboration with NIAID and BARDA. In parallel, we are scaling up our manufacturing capability with our strategic partners, Lonza, Catalent and Rovi, to address this global health emergency with a safe and effective vaccine.”

The company entered phase 3 back in late July and if the U.S. Food and Drug Administration (FDA) authorizes their vaccine, then doses would be distributed and used as part of a COVID-19 vaccination campaign.