Johnson & Johnson Receives the US FDA’s EUA for COVID-19 Vaccine

March 1, 2021 Auto Bot EUA, FDA, Johnson & Johnson, receives, regulatory, Vaccine 0

Shots:

  • The FDA has issued a EUA for a single-shot COVID-19 vaccine to prevent COVID-19 in individuals aged ≥18yrs. The company plans to file BLA to the US FDA in 2021
  • The EUA is based on a P-III ENSEMBLE study that demonstrated 85% efficacy in preventing severe disease across all regions and protect against COVID-19 related hospitalization and death, across countries with different variants
  • The EUA follows a unanimous vote by the US FDA’s VRBPAC on Feb 26, 2020. The company plans to deliver 100M doses to the US in the H1’21

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Law.com

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