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# Moderna Covid-19 Vaccine Gets Fast Track
- URL: https://www.fdaweb.com/moderna-covid-19-vaccine-gets-fast-track/
- Published: 2020-05-12T12:00:00.000Z
- Updated: 2026-09-14T16:14:38.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5146769

FDA has granted Moderna a fast track designation for its mRNA vaccine candidate (mRNA-1273) for Covid-19\. “As we await the full set of clinical data from the \[NIH\]-led Phase 1 study, we are actively preparing for our Phase 2 and Phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2,” the company said. Earlier this month, FDA completed its review of the IND for mRNA-1273 to proceed to a Phase 2 study, which is expected to begin shortly. Moderna is also finalizing the protocol for a Phase 3 study, expected to begin in early summer.

Feedback from FDA on the Phase 2 design, which will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart, supported the enrollment of 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300), according to the company. Each participant will be assigned to receive placebo, a 50 μg or a 250 μg vaccination dose. Participants will be followed through 12 months after the second vaccination.