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

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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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