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.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.