Mod­er­na floors it in­to PhI­II with their Covid-19 vac­cine, plan­ning quick start with a thumbs-up from FDA on tri­al de­sign, dosage

Right now, the over­ar­ch­ing strat­e­gy be­hind de­vel­op­ing a Covid-19 vac­cine calls for get­ting the work done fast. And Mod­er­na’s team is floor­ing their pro­gram in­to a Phase III piv­otal in a mat­ter of weeks af­ter se­lect­ing the dose need­ed.

The mes­sen­ger RNA biotech re­port­ed this morn­ing that it is ad­vanc­ing its coro­n­avirus vac­cine — mR­NA-1273 — in­to a piv­otal Phase III with 30,000 par­tic­i­pants start­ing in Ju­ly, just weeks away. With feed­back from the FDA, Mod­er­na has set­tled on the tri­al de­sign and a 100 μg dose, and they have the man­u­fac­tur­ing ca­pac­i­ty lined up to pro­duce any­where from 500 mil­lion to 1 bil­lion dos­es a year start­ing in 2021. Work­ing in col­lab­o­ra­tion with the NIH, Mod­er­na has al­so won con­sid­er­able back­ing from BAR­DA.

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