Moderna Anticipates the Initiation of P-III Study of mRNA-1273 for COVID-19 by Early Summer

Shots:

• The company reported in its Q1 results that the US FDA has accepted its NDA of (mRNA-1273) and allow it to initiate P-II study evaluating the therapy in 600 patients divided into two cohorts, aged 18-55yrs. and another of people aged 55+ yrs., expected to begin shortly
• Moderna is finalizing the protocol for P-III study of mRNA-1273 and is expected to initiate the clinical study in early summer of 2020
• With the focus of initiating the mRNA-1273 Phase III study early this summer, Moderna is now preparing to potentially have its first approved BLA as early as 2021. Additionally, the company highlighted its deal with Lonza to manufacture up to 1B doses of mRNA-1273/yr.

Click here to­ read full press release/ article | Ref: Moderna | Image: NY Times

Related News: Moderna Signs a Ten-Year Worldwide Agreement with Lonza to Manufacture mRNA-1273 Against COVID-19