Moderna to Initiate P-III Study of its mRNA-1273 Against COVID-19 in July 2020

 Moderna to Initiate P-III Study of its mRNA-1273 Against COVID-19 in July 2020

Moderna to Initiate P-III Study of its mRNA-1273 Against COVID-19 in July 2020

Shots:

  • The P-III study will evaluate mRNA-1273 vs PBO in a ratio (1:1) and is expected to enroll ~30,000 patients in the US, to be conducted in collaboration with NIAID. The 1EP of P-III study will be the prevention of symptomatic COVID-19 while 2EP include prevention of severe COVID-19
  • The company has finalized 100 μg as a P-III dose based on the results of P-I study. Moderna will deliver ~500M doses/ year or may ramp up to ~1B doses/ year under a manufacturing agreement with Lonza and is expected to be initiated in 2021
  • BARDA has supported the planning for the P-II and P-III studies of mRNA-1273 as well as the manufacturing scale-up of mRNA-1273. In P-II study, the company has completed the r enrollment of younger adults (n=300) and the sentinel group of older adults (n=50)

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

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

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