Last month, the USA proposed Operation Warp Speed (OWS) for massive COVID-19 vaccine testing attempt to meet year-end deadlines.
"Moderna is committed to advancing the clinical development of mRNA-1273 as safely and quickly as possible to demonstrate our vaccine's ability to significantly reduce the risk of COVID-19 disease", he added.
He has decades of experience co-ordinating with global colleagues on vaccine development.
"We have leveraged the Institute's expertise and infrastructure to be able to compress what would, under normal circumstances, be two years of discovery and design work into several months", said Dr. Kayvon Modjarrad, director of the emerging infectious disease branch of the Walter Reed Army Institute of Research.
Moderna has finalized the Phase 3 study protocol based on feedback from the U.S. FDA.
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The clinical trial will be randomised, 1:1 placebo-controlled trial and is anticipated to include almost 30,000 participants to be enrolled in the US.
"We look forward to beginning our Phase 3 study of mRNA-1273 with some 30,000 participants in July", said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna, in a statement. The Company disclosed that manufacturing of vaccine with Lonza had been scaled up and on track to provide 500 million - 1 billion 100 μg doses annually.
The randomised, placebo-controlled phase 1/2A study will evaluate the safety of the vaccine, as well as how participants respond to it and their resulting immune response.
Moderna Therapeutics has announced that its COVID-19 vaccine is set to go into the third and final stage of clinical human trials. According to the biotech company, their primary endpoint is to prevent symptomatic Coronavirus, and their secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2.