COVID-19Regulatory

Moderna’s COVID-19 Vaccine Moves to Phase 2 Testing, and Gets Fast-Track Approval From the U.S. Government

May 12, 2020 / BY ALICE PARK 

On May 12, Moderna Therapeutics, based in Cambridge, Mass., received fast-track approval from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine candidate, mRNA-1273. Days earlier, the FDA gave the company the green light to proceed to Phase 2 testing of the vaccine, which is expected to begin shortly. The company plans to launch the final stage of human testing, Phase 3, this summer, assuming the Phase 2 studies are complete, says Dr. Stephen Hoge, president of Moderna.

Fast-track designation boils down to a more expedited review process by the FDA. In particular, it means the agency can review data on a rolling basis so an entire application for approval isn’t held up until the final piece of data is collected and analyzed. “It’s validation that the FDA believes this is a very credible exercise,” says Hoge.

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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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