CAMBRIDGE, MASS. (WHDH) - The United States Food and Drug Administration granted Fast Track designation for a Cambridge-based biotechnology company’s coronavirus vaccine.
Fast Track will facilitate the development and expedite the review of Moderna’s vaccine candidate (mRNA-1273).
“Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. “As we await the full set of clinical data from the NIAID-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.”
On May 6, the FDA completed its review of Moderna’s Investigational New Drug application for mRNA-1273, allowing the company to move forward with phase two of their vaccine trial 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.
Protocol for phase three of the study is being finalized, which is expected to begin in the early summer of this year.
(Copyright (c) 2024 Sunbeam Television. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.)