Moderna Inc. (MRNA) said late Monday its candidate for a coronavirus vaccine will get to be evaluated further. The biotech company said it has submitted a new-drug application with the U.S. Food and Drug Administration to evaluate the vaccine candidate, mRNA-1273, in a more extensive study if supported by safety data from an initial study. The phase 2 study is expected to begin in the second quarter, Moderna said. That will evaluate the safety and any adverse reactions and immune responses of two mRNA-1273 vaccinations given 28 days apart, the company said. Each person participating in the study will be assigned to receive a placebo or different doses of the vaccine candidate, Moderna said. The plan is to enroll 600 healthy adults and older adults in two cohorts, Participants will be followed through 12 months after the second vaccination, Moderna said. "Submitting this (investigative new-drug application) is an important next step in the clinical development of our mRNA vaccine against SARS-CoV-2, and we are moving rapidly to potentially address this global health emergency," Moderna's Chief Medical Officer Tal Zaks said in a statement. A third phase could begin in the fall of 2020, the company said. Moderna is one ofnearly two dozen U.S. companies working on a vaccine ( COVID-19 as the disease has killed more than 200,000 worldwide. ( )
-Claudia Assis; 415-439-6400; AskNewswires@dowjones.com
(END) Dow Jones Newswires
April 27, 2020 17:06 ET (21:06 GMT)
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