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

 ­ Ref: PRNewswire | Image: Law.com