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US firm, Moderna, kick-starts Phase III clinical trial of COVID-19 vaccine candidate

Moderna has announced that the Phase III study of its mRNA vaccine candidate (mRNA-1273) against COVID-19 has begun dosing participants. 

The Phase III study, called the COVE (Coronavirus Efficacy) study, is being conducted in collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, a report by the European Pharmaceutical Review says.

mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a pre-fusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. 

“We are pleased to have started the Phase III COVE study,” said Stephane Bancel, Chief Executive Officer at Moderna.

Phase III: If a vaccine is a car, the Phase I and Phase II trials happen while it’s still in the factory. In those trials, scientists are still trying to assemble a vaccine that might work — they’re figuring out the pieces that they might need and how they should be used. If that assembly process goes well, the vaccine candidate can move into Phase III, where it’s taken for a heavily monitored ride in test tracks and the real world. “Phase I and II lets you say, ‘we have a lot of things we need to clarify and decide on,’” Alex John London, director of the Center for Ethics and Policy at Carnegie Mellon University, explains to The Verge.

“We are grateful to the efforts of so many inside and outside the company to get us to this important milestone. We are indebted to the participants and investigators who now begin the work of the COVE study itself. We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic.” Chief Executive Officer at Moderna added.

With its collaborators, Moderna has selected nearly 100 clinical research sites with representative demography and is partnering closely with those sites to ensure that volunteers at increased risk for COVID-19 disease are enrolled in the study. 

Moderna’s goal for Phase III is to recruit 30,000 people, inject some of them with an experimental vaccine and then follow each and every one of them to see how many contract the coronavirus and how many do not; a process that will take months.

Moderna says it remains on track to be able to deliver approximately 500 million doses per year and possibly up to one billion doses per year, beginning in 2021 because of the company’s internal US manufacturing capabilities 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 biologic facility for the US and with ROVI of Spain for fill-finish manufacturing outside the US.

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