- Moderna Inc (NASDAQ: MRNA) announced it has received an additional $472 million from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of a novel coronavirus vaccine. Now the total value of the award is about $955 million.
Moderna Inc (NASDAQ: MRNA) announced it has received an additional $472 million from the Biomedical Advanced Research and Development Authority (BARDA) in order to support the development of a novel coronavirus vaccine. The additional commitment of up to $472 million will be used to support late-stage clinical development including the expanded Phase 3 study of the Moderna’s mRNA vaccine candidate (mRNA-1273) against COVID-19.
BARDA earlier provided an award for up to $483 million to support the scale-up of mRNA-1273 and clinical development (originally with a smaller anticipated number of participants in the Phase 3 clinical trial). After discussions with the U.S. Food and Drug Administration (FDA) and consultations with Operation Warp Speed during the past few months, Moderna has decided to conduct a much larger Phase 3 clinical trial thus leaving a gap in BARDA funding that will be closed by this contract modification.
As part of the revised contract, BARDA is expanding its support of Moderna’s late-stage clinical development of mRNA-1273, including the execution of a 30,000 participant Phase 3 study in the U.S. Now the total value of the award is approximately $955 million.
The Phase 3 COVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) — which is part of the National Institutes of Health (NIH) — and is expected to begin tomorrow (July 27). And the Phase 3 study protocol has been reviewed by the U.S. Food and Drug Administration (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 about 30,000 participants at the 100 µg dose level in the U.S.
Moderna is working closely with Operation Warp Speed and the NIH — including NIAID’s COVID-19 Prevention Trials Network (CoVPN) — to conduct the Phase 3 COVE study. And working together with collaborators like NIH, Moderna hopes to achieve a shared goal that the participants in the COVE study are representative of the communities at the highest risk for COVID-19 and of our diverse society.
Moderna 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 Moderna’s internal U.S. manufacturing site and strategic collaboration with Lonza. And 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. The initial funding of $1.3 billion for Moderna to start producing mRNA-1273 supply at-risk was secured from investors in the company’s public equity offering in May 2020.
mRNA-1273 is known as an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein — which was selected by Moderna in collaboration with investigators from the VRC. And the first clinical batch, funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020, and underwent analytical testing; it was shipped to NIH on February 24 (42 days from sequence selection).
The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16 (63 days from sequence selection to Phase 1 study dosing). And on May 12, the FDA granted mRNA-1273 Fast Track designation.
Both of the cohorts, healthy adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300), in Moderna’s Phase 2 study of mRNA-1273 are fully enrolled.
“We thank BARDA for this continued commitment to mRNA-1273, our vaccine candidate against COVID-19. Encouraged by the Phase 1 data, we believe that our mRNA vaccine may aid in addressing the COVID-19 pandemic and preventing future outbreaks.”
— Stéphane Bancel, Moderna’s Chief Executive Officer
Disclosure: I own a few shares of Moderna in my stock portfolio