FDA grants Fast Track Designation to Moderna’s COVID-19 vaccine

Moderna has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for the company’s mRNA vaccine candidate, named mRNA-1273, against COVID-19, caused by the SARS-CoV-2 virus. 

“Fast Track Designation underscores the urgent need for a vaccine against COVID-19,” said Dr Tal Zaks, Chief Medical Officer at Moderna. “As we await the full set of clinical data from the National Institute of Allergy and Infectious Diseases (NIAID)-led Phase I study, we are actively preparing for our Phase II and Phase III clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2.”

Programmes with Fast Track Designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application. 

mRNA-1273 encodes a prefusion stabilised form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the NIAID, a part of the US National Institutes of Health (NIH). 

On 6 May, the FDA completed its review of the company’s Investigational New Drug (IND) application for mRNA-1273, allowing it to proceed to a Phase II study, which is expected to begin shortly. Moderna is finalising the protocol for a Phase III study, expected to begin in early summer of 2020. Funding from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS), supported the planning for these studies and will also support the late-stage clinical development programmes, as well as the scale-up of mRNA-1273 manufacturing both at the company’s facilities and that of its collaborator, Lonza Ltd.

For its Phase II trial, Moderna intends to enrol 600 healthy participants across two cohorts of adults ages 18-55 years and older adults ages 55 years and above. Each participant will be assigned to receive placebo, a 50μg or a 250μg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination.