Moderna received FDA Fast Track Designation for mRNA vaccine (mRNA-1273) against novel Coronavirus
On May 12, 2020, Moderna announced the U.S. Food and Drug Administration (FDA had granted Fast Track designation for the Company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2).
The Company intended to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300). Each participant was assigned to receive placebo, a 50 ᄉg or a 250 ᄉg dose at both vaccinations. Participants were followed through 12 months after the second vaccination.
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Source: Moderna
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