COVAXIN Is Undergoing Clinical Trials In Children

The Drugs Controller General of India (DCGI) has given permission to Bharat Biotech Ltd to conduct a Phase II/III clinical trial of Covaxin (COVID vaccine) in children aged 2 to 18.
Sheena

Updated: May 15, 2021 03:40:35 pm

15 May 2021 Current Affairs:COVAXIN's Phase II/III clinical trial in children aged 2 to 18 years has been approved by the DCGI.

Highlights:
♦ The Drugs Controller General of India (DCGI) has given permission to Bharat Biotech Ltd to conduct a Phase II/III clinical trial of Covaxin (COVID vaccine) in children aged 2 to 18.
♦ In the trial, the vaccine will be given by intramuscular injection twice on day 0 and day 28.
♦ A total of 525 healthy volunteers will participate in the trial. 
♦ The proposal was debated by the Subject Expert Committee (SEC) (COVID-19) in May 2021 as a fast regulatory response. Following extensive deliberation, the Committee recommended that permission be granted to perform the planned Phase II/III clinical trial under certain conditions.
 
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