FDA grants fast-track status to Moderna's mRNA-1273 vaccine candidate for coronavirus

Moderna said Tuesday that the FDA has granted a fast-track designation for the company's mRNA-1273 vaccine candidate against SARS-CoV-2. The designation "underscores the urgent need for a vaccine," commented Tal Zaks, chief medical officer at Moderna, adding "as we await the full set of clinical data from the [US 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."

The company secured FDA approval last week to proceed with Phase II testing of two vaccinations of mRNA-1273 given 28 days apart. The study is expected to enroll a total of 600 participants into two cohorts, one with adults between ages 18 and 55, and another with subjects aged 55 years and older. Moderna said it is also finalising the protocol for a late-stage study, which is expected to begin in early summer.

Moderna recently entered into a partnership with Lonza, saying it hoped to be able to produce up to 1 billion doses of mRNA-1273 per year, with the first batches of the vaccine candidate slated for production in the US in July.

For related analysis, listen to our latest podcast from FirstWord executive editors Simon King and Michael Flanagan, which includes a discussion on the race to develop an effective vaccine.  

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