Dosing begins in Moderna's late-stage study of COVID-19 vaccine candidate

Moderna announced Monday that patient dosing started in the Phase III COVE study of its mRNA-based vaccine candidate against the novel coronavirus, sending company shares up as much as 11.3%. The trial of mRNA-1273 is being conducted in collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) as part of the US government's Operation Warp Speed initiative.

The randomised study is expected to include approximately 30,000 participants in the US testing mRNA-1273 at a dose of 100 mcg against placebo. Volunteers will receive two intramuscular injections given approximately 28 days apart. The trial's primary endpoint is prevention of symptomatic COVID-19 disease, while key secondary goals include prevention of severe COVID-19 disease, defined by the need for hospitalisation, and prevention of infection by SARS-CoV-2 regardless of symptomology.

"Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it's the right goal for the American people," commented NIH director Francis Collins. Anthony Fauci, his counterpart at the NIAID, last week suggested that a coronavirus vaccine is unlikely to be "widely available" until several months into next year.

US supply deal likely

Moderna said it remains on track to deliver about 500 million doses of mRNA-1273 a year, and possibly up to 1 billion doses annually, beginning in 2021. The company has so far received nearly $1 billion from the US government to support development of its COVID-19 vaccine, including a recent commitment of up to $472 million from BARDA to support the COVE trial. BMO Capital Markets predict that a US supply deal with Moderna for its vaccine candidate is inevitable, while the drugmaker will probably also strike deals with other governments as well.

Earlier this month, an interim analysis published in the NEJM suggested that mRNA-1273 induced "robust" neutralising antibody titers in all 45 study subjects. T-cell responses were also evaluated, with Moderna noting at the time that after the second vaccination, mRNA-1273 "elicited Th1-biased CD4 T-cell responses without significant elevation of Th2-biased CD4 T-cell responses." The vaccine was said to produce mild-to-moderate side effects, typically after the second dose, including fatigue, chills, headache, muscle pain and pain at the injection site.

Moderna recently lost a US patent challenge brought against Arbutus Biopharma over the latter's lipid nanoparticle delivery technology, potentially affecting mRNA-1273. An analyst said the outcome opens the door to a "likely protracted period of...debate around the implications of any potential infringement of claims." For additional analysis, see ViewPoints: Arbutus aims for a piece of the Moderna pie

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