The U.S. government has awarded Moderna an additional up to $1.525 billion toward manufacturing and delivering 100 million doses of the company’s front-running COVID-19 messenger RNA (mRNA) vaccine candidate mRNA-1273.

The new funding, combined with up to $955 million previously committed to Moderna, more than doubles Washington’s investment in the company to potentially up to $2.48 billion.

The new funding includes an unspecified amount of incentive payments “for timely delivery of the product,” Moderna added. The company did say, however, that the U.S. government holds an option to purchase from it up to an additional 400 million doses of mRNA-1273.

mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA vaccine encoding for a prefusion stabilized form of the Spike (S) protein. mRNA-1273 is one of 17 “Front Runner” candidates among the more than 280 COVID-19 therapeutics included in GEN’s updated “COVID-19 DRUG & VACCINE CANDIDATE TRACKER.”

Moderna partnered with investigators from the National Institute of Allergy and Infectious Disease’s (NIAID) Vaccine Research Center to co-develop mRNA-1273.

NIAID and Moderna are now conducting an approximately 30,000-patient Phase III trial of mRNA-1273. The study, launched last month, is being funded among late-stage clinical activity for which the company won up-to-$472 million from BARDA.

The Phase III COVE trial (NCT04470427) is designed to evaluate the safety of mRNA-1273 in 30,000 adult volunteers who do not have COVID-19. The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease, as defined by the need for hospitalization), and prevention of infection by SARS-CoV-2.

On Track for September

Enrollment is on track to be completed in September, Moderna said.

Participants in the trial will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned 1:1 to receive either two 100 µg injections of mRNA-1273 or two shots of a saline placebo.

The U.S. Department of Health and Human Services (HHS) and Defense (DoD) announced Moderna’s most recent funding late yesterday as part of Operation Warp Speed—the program through which President Donald Trump’s administration has committed the nation to delivering 300 million vaccine doses protecting against SARS-CoV-2 by January 2021.

The government says its 300 million dose goal is part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

Operation Warp Speed funds and coordinates development of vaccines, drugs, and diagnostics across agencies of DoD and HHS—the latter agency including the FDA, the NIH, the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA).

BARDA and the DoD Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense and the Army Contracting Command partnered to furnish the funding.

“We appreciate the confidence of the U.S. government in our mRNA vaccine platform and the continued support,” Moderna CEO Stéphane Bancel said in a statement. “We are advancing the clinical development of mRNA-1273 with the ongoing Phase III study being conducted in collaboration with NIAID and BARDA.”

Scaling up manufacturing

At the same time, Bancel added, Moderna is scaling up its manufacturing capability with three partner companies with which the vaccine developer has reached agreements of undisclosed value.

In May, Moderna signed a 10-year agreement with Lonza through which the companies agreed to establish manufacturing suites for Moderna at Lonza’s facilities in the U.S. and Switzerland for the production of mRNA-1273. The value of that agreement has not been disclosed.

In June, Moderna and Catalent agreed to conduct large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Bloomington, IN. Catalent agreed to provide vial filling and packaging capacity, as well as additional staffing required for 24×7 manufacturing operations at the site to support production of an initial 100 million doses of the vaccine candidate intended to supply the U.S. market starting in the third quarter.

And last month, Moderna agreed to team up with Laboratorios Farmacéuticos Rovi (ROVI) to carry out large-scale, commercial fill-finish manufacturing of mRNA-1273 at ROVI’s facility in Madrid, Spain.

Upon FDA authorization, Moderna said, Americans would receive mRNA-1273 “at no cost for the vaccine itself,” but cautioned that healthcare professionals could charge for the cost of administering the vaccine “as is customary with government-purchased vaccines.”

BARDA previously agreed to support R&D for mRNA-1273 with $955 million in federal funding under Contract no. 75A50120C00034. The up to $1.525 billion in new funding for mRNA-1273 is being awarded under U.S. Department of Defense Contract No. W911QY-20-C-0100.

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