Moderna has secured fast track designation from the US Food and Drug Administration (FDA) for its mRNA-1273, the mRNA vaccine candidate against the novel coronavirus (SARS-CoV-2).
Earlier this month, the FDA has completed its review of Moderna’s investigational new drug (IND) application for mRNA-1273 to conduct Phase 2 study, which is expected to be commenced within a short time.
The company is also working to finalise the protocol for a phase 3 study, which is expected to start in the early summer of this year.
The mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilised form of the Spike (S) protein, which was selected by Moderna in partnership with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of NIH.
Moderna secured funding from the Biomedical Advanced Research and Development Authority (BARDA) to conduct the studies, as well as enter into the late-stage clinical development programmes.
In April, Moderna secured a funding commitment of up to $483m from BARDA, the US Government agency.
The phase 2 study is designed to assess the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.
Moderna is planning to recruit up to 600 healthy participants across two cohorts of adults ages 18-55 years and older adults ages 55 years and above.
Moderna will also focus on the advancement of manufacturing capabilities for mRNA-1273 at its facilities, in addition to its strategic collaborator Lonza.
Earlier, the company secured fast track designation for its investigational Zika vaccine (mRNA-1893) and its methylmalonic academia, as well as propionic acidemia (PA; mRNA-3927) programmes.
Moderna chief medical officer Dr 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.”