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April 28, 2020

Moderna seeks FDA approval for Phase II trial of Covid-19 vaccine

Moderna has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) to conduct a Phase II clinical trial of its mRNA vaccine candidate, mRNA-1273, against Covid-19.

The study is expected to be supported by safety data from the ongoing Phase I study, which is led by the US National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID).

Moderna said that the FDA provided initial feedback on the design of the Phase II study, which is set to launch in the second quarter of this year.

Read the full article here

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