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FDA grants Fast Track designation for Moderna’s coronavirus vaccine candidate

Published on 13/05/20 at 12:47pm
Photo by FDA

The FDA has granted Fast Track designation for Moderna Inc’s mRNA vaccine candidate against the coronavirus.

The regulatory body had completed its review of the company’s Investigational New Drug (IND) application for mRNA-1273, allowing it to proceed with a Phase 2 study. It has also allowed Moderna to finalise the preparations for a Phase 3 study, which is expected to begin in the summer.

Dr Tal Zaks, the Chief Medical Officer at Moderna, 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.”

The mRNA-1237 vaccine against coronavirus has an encoding for a prefusion stabilised form of the spike protein. It was selected in collaboration with investigators from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID). 

More than 1,400 participants have been enrolled in Moderna’s vaccine clinical studies and the data shows that it has been generally well-tolerated and can elicit durable immune responses to viral antigens.

The upcoming Phase 2 study intends to enrol 600 healthy patients between the ages of 18-55 years old, and each participant will be assigned to receive either a placebo or a 50ug/250ug dose of the vaccine.

Conor Kavanagh

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