Moderna Receives FDA Clearance for Phase 2 Study of mRNA-1273 Novel Coronavirus Vaccine

Moderna, Inc. (Cambridge, MA, USA) is making progress on its novel coronavirus vaccine (mRNA-1273) and has received clearance from the US Food and Drug Administration (FDA) to proceed with its Phase 2 study.

The US FDA has completed its review of the company’s Investigational New Drug (IND) application for its novel coronavirus (SARS-CoV-2 or COVID-19) vaccine candidate (mRNA-1273), allowing it to proceed to Phase 2 study which is expected to begin shortly. A 600 participant Phase 2 study is expected to begin shortly and Moderna is now finalizing the protocol for the Phase 3 study, which is expected to begin in the early summer of 2020.

“The imminent Phase 2 study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2. With the goal of starting the mRNA-1273 pivotal Phase 3 study early this summer, Moderna is now preparing to potentially have its first BLA approved as soon as 2021. We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective,” said Stéphane Bancel, Moderna’s Chief Executive Officer.

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