Clinical trials of Covaxin commenced on children in AIIMS Patna

Clinical trials of Covaxin commenced on children in AIIMS Patna

Covaxin has been developed by Bharat Biotech and has been administered in adults in the ongoing vaccination drive in India. 
 
covaxin

The clinical trials began after the nod of DCGI. 

The trials are also to be conducted in AIIMS Delhi and Meditrina Institute of Medical Sciences Nagpur for the 2-18 year old. children

Clinical trials of Covaxin have been commenced in AIIMS Patna in children in the 2-18 yr age group. The trials began after the nod of the Drug Controller General of India (DCGI).

The trials will also be conducted in AIIMS, Delhi and Meditrina Institute of Medical Sciences, Nagpur in 525 subjects at various sites.

In the month of May Subject Expert Committee had intensely discussed upon Hyderabad-based Bharat Biotech’s application seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.

After detailed deliberation, the committee recommended for the conduct of proposed phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study.

(inputs from india.com)

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