Shots:

• The EUA submission is based on P-III ENSEMBLE trial assessing the safety and efficacy of the COVID-19 vaccine in protecting adults aged ≥18yrs. against both mod. and sev. COVID-19 disease with assessment of efficacy as of day 14 and as of day 28 as co-1EPs
• The study demonstrated that single-dose vaccine met all 1EPs & 2EPs. The company has initiated rolling submissions with several health agencies outside the US- and will submit a cMAA with the EMA in the coming weeks
• The company intends to distribute vaccine to the US government imminently- following the authorization- and expects to supply 100M doses to the US in the H1’21

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