Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study

December 1, 2020 Auto Bot EUA, Moderna, mRNA, regulatory, Severe, Us FDA, Vaccine 0

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

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

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