- Posted by ISPE Boston
- On May 14, 2020
The FDA has granted Fast Track designation for Moderna’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2). In explanation, Moderna’s Chief Medical Officer Tal Zaks said, “Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus. 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.”
Fast Track status is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and fill an unmet medical need. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application. Moderna previously received Fast Track designation for its investigational Zika vaccine (mRNA-1893) and its methylmalonic acidemia (MMA; mRNA-3704) and propionic acidemia (PA; mRNA-3927) programs.
On May 6, the FDA completed its review of Moderna’s Investigational New Drug (IND) application for mRNA-1273 allowing it to proceed to a Phase 2 study, which is expected to begin shortly. Moderna is finalizing the protocol for a Phase 3 study, expected to begin in early summer of 2020. Funding from BARDA supported the planning for these studies and will also support the late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacturing both at the Company’s facilities and that of its strategic collaborator, Lonza. (Source: Moderna Website, 12 May, 2020)