Moderna to Seek the FDA and EMA's EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study
Shots:
- The P-III COVE study demonstrated 94.1% efficacy against COVID-19 and 100% efficacy against severe COVID-19. The vaccine was well tolerated with no serious safety concerns identified to date
- Moderna plans to submit an EUA to the FDA & an application for CMA with the EMA and to progress with the rolling reviews- which have already been initiated with international regulatory agencies
- The FDA has told Company to expect VRBPAC meeting for mRNA-1273 on Dec 17- 2020. The Company will submit data from the P-III COVE study to a peer-reviewed publication
Ref: Moderna | Image: Moderna
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