Moderna’s mRNA-1273 vaccine candidate has received fast track designation from the US FDA. Credit: Shutterstock.com

The US Food and Drug Administration (FDA) has awarded fast-track designation to Moderna mRNA vaccine candidate, mRNA-1273, developed to protect against Covid-19.

Fast-track designation enables development and speed-up of the review of therapies and vaccines that target serious conditions and fill an unmet medical need.

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Programmes with the designation could see early and frequent communication with the FDA, along with a rolling submission of the marketing application.

Previously, Moderna obtained fast-track designation for its investigational Zika vaccine, methylmalonic acidemia and propionic acidemia programmes.

Moderna 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 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.”

The FDA completed its review of the investigational new drug (IND) filing for mRNA-1273 on 6 May, allowing the launch of a Phase II clinical trial.

The Phase II study will assess the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 administered 28 days apart. It will enrol 600 healthy volunteers aged 18 years and above.

Participants will be given placebo, a 50μg or a 250μg dose at both vaccinations and followed through 12 months following the second vaccination.

The company is finalising the protocol for a Phase III study. The Biomedical Advanced Research and Development Authority (BARDA) funding helped plan these studies and will support the late-stage clinical programmes.

In addition, the funding will be used to scale up manufacturing of the vaccine candidate at the company’s facilities and at that of its strategic partner, Lonza.