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Bharat Biotech Initiates P-III Study for Covaxin Against COVID-19

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Bharat Biotech Initiates P-III Study for Covaxin Against COVID-19

Shots:

  • Following the successful completion of the interim analysis from the P-I & P-II clinical trials of Covaxin- the company has received the DCGI approval to conduct a P-III study of its COVID-19 vaccine
  • The study will assess Covaxin (6mcg- IM at an interval of 28days) vs PBO in ~26-000 volunteers in a ratio (1:1) aged ≥18yrs. in over 25 centers across India and is being conducted in partnership with ICMR. It is the largest clinical trial conducted for a COVID-19 vaccine in India
  • Bharat Biotech plans to launch Covaxin by June’2021- unless the government decides to give the vaccine a EUA before that- based on data from earlier phases of clinical trial

Source 1- Source 2 ­ Ref: Bharat Biotech- NDTV | Image: MediCircle

Click here to­ read the full press release 

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