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.
The Phase 2 studies will include around 600 healthy volunteers, half of whom are 18-55 years old and half of whom are over 55 years old. They will be randomly assigned to receive either placebo or one of two doses of Moderna’s experimental vaccine. Each participant will receive two shots—early studies suggest two injections might be necessary to jump-start the immune system to generate protection against the COVID-19 virus. All the patients will then be followed for a year as the researchers monitor their immune responses.
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