12th May, 2021
Bharat Biotech will soon begin the second and third phase clinical trials of its anti-corona vaccine covaxin on children aged two to 18 years. The committee of experts constituted on Corona gave its recommendation for starting the trial on Tuesday. Official sources have given this information.
The trial will be conducted at 525 volunteers at various centers in the country, including AIIMS in Delhi and Patna and the Meditrina Institute of Medical Sciences in Nagpur.
Hyderabad-based Bharat Biotech sought permission to assess the safety and immunity of covaxin on children aged two to 18 years. The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO), set up on Corona, on Tuesday recommended Bharat Biotech's application for a trial after extensive deliberations.
The SEC, while recommending the second and third phase trials, has also stipulated that Bharat Biotech will provide the interim data of Phase II security to CDSCO before starting the Phase III clinical trial.
It is worth noting 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, covaxin is also being used along with the covishield being made by the Serum Institute in vaccination campaigns.