Written by: Alex Keown.
Shares of Moderna jumped nearly 11% from the moment the bell rung this morning following its announcement that it received regulatory permission to begin a Phase II study of its mRNA vaccine candidate for COVID-19.
In a brief announcement this morning, Moderna said it expects to begin the mid-stage study soon with 600 patients and is finalizing protocols for a hoped-for Phase III study mRNA-1273, which is expected to begin in early summer of 2020.
Stéphane Bancel, Moderna’s chief executive officer, said the Phase II study is a crucial step in advancing the vaccine candidate as the company looks toward the goal of moving into Phase III. If all goes well, Bancel said the company is making plans to have a Biologics License Application for the vaccine up for approval in early 2021. Having a vaccine for COVID-19 available as quickly as possible is one step in helping society return to a greater sense of normalcy.
“We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective,” Bancel said in a statement.
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