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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