US Government’s Commitment Reaches $955 Million For mRNA Vaccine Candidate

Moderna expands mRNA-1273 vaccine phase 3 study (COVE)
depiction of RNA

A Massachusetts based biotechnology company announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) for an additional commitment of up to $472 million to support the Company’s Messenger RNA vaccine candidate (mRNA-1273) against the SARS-CoV-2 betacoronavirus.

The additional funding includes support for the 30,000 participant Phase 3 COVE study conducted in collaboration with the U.S. NIH.

Moderna, Inc. stated in a press statement on July 26, 2020, this new financial support increases the total BARDA award to approximately $955 million.

Stéphane Bancel, Moderna’s Chief Executive Officer, said in a press statement: “Encouraged by the Phase 1 data, we believe that our mRNA-1273 vaccine may aid in addressing the COVID-19 pandemic and preventing future outbreaks.”

Furthermore, the 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 2020.

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 U.S. manufacturing site and strategic collaboration with Lonza.’ 

In addition, Moderna recently announced a collaboration with Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Indiana.

mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna. mRNA, plays a fundamental role in human biology, transferring the instructions stored in DNA to make the proteins required in every living cell.

The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats, and manufacturing agility derived from the platform nature of mRNA vaccine design and production, said the Company.

The first clinical batch was completed on February 7, 2020, and underwent analytical testing. It was shipped to NIH in just 42 days from sequence selection.

Based on the results of a Phase 1 study, the 100 μg dose level was chosen to maximize the immune response, while minimizing adverse reactions.

Previously, the U.S. FDA granted mRNA-1273 Fast Track designation on May 12th.

This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00034. BARDA is part of the U.S. Department of Health and Human Services.

Precision Vaccinations publishes COVID-19 vaccine development news.