FDA Grants Coronavirus mRNA Vaccine Fast Track Designation

Moderna’s coronavirus disease 2019 (COVID-19) vaccine candidate mRNA-1273 has been granted Fast Track designation by the US Food and Drug Administration (FDA), according to a company press release.

The investigational mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the coronavirus’ Spike protein.

A fast track designation expedites review for treatments which fill an unmet medical need. The designation encourages communication between drug developers and the FDA. Moderna previously received Fast Track designation for an investigational Zika vaccine.

“Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus,” Tal Zaks, MD, PhD, Chief Medical Officer at Moderna, said in the press release.

Moderna submitted an investigational new drug application to the FDA on April 27 and was approved for a Phase 2 study on May 7.

“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,” Zaks said.

The Phase 2 study will aim to explore the safety, immunogenicity, and reactogenicity of 2 doses of mRNA-1273 administered 28 days apart.

Phase 2 Study Parameters:

• A total of 600 participants will be assigned to receive placebo, 50 μg, or 250 μg of the vaccine in both vaccinations. Participants will then be followed for 12 months after vaccination.

• Participants will range from 18-55 years in a 300 person cohort, and 55 years+ in another 300 person cohort.

• Participants will be followed through 12 months after the second vaccination.

Moderna is also finalizing the protocol for the Phase 3 study, expected to begin in the summer of this year. The planning for these studies, late-stage clinical development programs, and the potential scale-up of manufacturing for the vaccine have been funded by the US Biomedical Advanced Research and Development Authority.

“Safe, effective vaccines are critical to ending this pandemic and preventing future outbreaks of SARS-COV-2,” said BARDA Acting Director Gary Disbrow, PhD, upon the May 7 submission of Moderna’s investigational new drug application.