New Delhi: Bharat Biotech’s Covaxin has been given a nod by an expert panel for phase-2 and 3 clinical trials on children between the age of two and 18 years, media reports said quoting news agencies.
The coronavirus vaccine is currently being used for those above 18 years of age. Covaxin has now been recommended to go through another clinical trial that will take place at various institutes across India. The trials will be done on 525 subjects at Delhi’s AIIMS and Meditrina Institute of Medical Sciences, Nagpur among others.
Bharat Biotech has been seeking permission to conduct phase II/III clinical trials to evaluate the safety of Covaxin jabs in children aged 2 to 18 years. It finally received a recommendation from the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Tuesday, ANI reported.
The committee said that after detailed deliberation the members have recommended conducting the proposed clinical trial for the firm to submit the interim safety data along with the Data and Safety Monitoring Board (DSMB) recommendations to the CDSCO before proceeding to phase III part of the study
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