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Massachusetts-based Moderna Therapeutics said Thursday that the FDA has given it the go-ahead for a 600-person Phase 2 study for its coronavirus vaccine candidate.
"The imminent Phase 2 study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2," Moderna CEO Stéphane Bancel said in a statement. "With the goal of starting the mRNA-1273 pivotal Phase 3 study early this summer, Moderna is now preparing to potentially have its first [Biologics License Application] approved as soon as 2021."
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Moderna is finalizing protocols for a Phase 3 study expected to begin in "early summer of 2020."
Moderna is one of many companies throughout the globe racing to create a coronavirus vaccine. The Trump administration is pushing for rapid vaccine development through a recently announced project called Operation Warp Speed.
"I think we'll have a vaccine by the end of the year," President Trump said Sunday at a Fox News town hall.
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Experts warn that developing such a vaccine could take years, not months.
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"Vaccine development in general involves … a high risk of failure. These vaccines can't be developed overnight," vaccine policy expert Kelly Cappio of Avalere Health told FOX Business.
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Moderna and Swiss biotech and chemicals company Lonza announced last week that they are partnering in order to scale up production of a possible vaccine. The companies say they're aiming for production capability of one billion doses a year.
Moderna's stock is hovering around $50 per share after trading at $24.55 a year ago.
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In addition, the government's Biomedical Advanced Research and Development Authority (BARDA) committed $483 million to Moderna to scale up production.