The Subject Expert Committee has also stipulated that India will provide interim data of Phase 2 safety to CDSCO before commencing Phase 3 clinical trials, recommending Phase 2 and Phase 3 trials.
Bharat Biotech will soon begin the second and third phase clinical trial of its anti-corona vaccine covaxin on children aged two to 18 years. The committee of experts constituted on Corona gave its recommendation for the trial to begin on Tuesday. Official sources have given this information. The trial test will be operated by 525 volunteers at different centres in the country, including AIIMS in Delhi and Patna and the Meditrina Institute of Medical Sciences in Nagpur.
Hyderabad-based Bharat Biotech sought a request to assess the safety and immunity of covaxin on children aged 2 to 18 years. Subject Expert Committee (SEC) of the Central Drug Standards Control Organization (CDSCO) on Tuesday after extensive discussion on the application of Bharat Biotech, it was recommended for trial.
The Subject Expert Committee has also stipulated that India will provide interim data of Phase II safety to CDSCO before commencing Phase III clinical trials, recommending Phase II and Phase III trials.
It is noted that Bharat Biotech has developed covaxin in collaboration with Indian Council of Medical Research (ICMR). The company is also producing and marketing it. In India, covishield as well as covaxin are being used in the vaccination campaign by the Serum Institute in vaccination campaigns.
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