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"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."
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.
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.
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.
In addition, the government's Biomedical Advanced Research and Development Authority (BARDA) committed $483 million to Moderna to scale up production.