CAMBRIDGE, MASS. (WHDH) - A Cambridge-based biotechnology company received approval from the United States Food and Drug Administration to continue on with phase two of their coronavirus vaccine trial.
The FDA recently completed its review of Moderna’s Investigational New Drug application for mRNA-1273, allowing the company to move forward with phase two of the study.
As part of phase two, 600 healthy participants will be assigned to receive a placebo, a 50 μg dose or a 250 μg dose of the vaccine twice, given 28 days apart.
The study will evaluate the safety, reactogenicity, and immunogenicity of the vaccination.
Finalizing protocol for phase three of the study is expected to begin in the early summer of this year.
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