Johnson & Johnson Reports EUA Submission to US FDA’s for its Single Shot COVID-19 Vaccine Candidate

February 5, 2021 Auto Bot EUA, FDA, Johnson & Johnson, regulatory, reports, Submission 0

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

Click here ­to­ read full press release/ article | Ref: J&J | Image: Yahoo Finance

The post Johnson & Johnson Reports EUA Submission to US FDA’s for its Single Shot COVID-19 Vaccine Candidate first appeared on PharmaShots.