Biological E gets DCGI approval to conduct phase 2/3 trials on children

New Delhi, September 03: Indigenous COVID-19 vaccine maker Biological E has received Drugs Controller General of India (DCGI) approval to conduct phase two and three clinical trials of its COVID-19 vaccine Corbevax on children aged five to eighteen years with certain conditions.

 

The ministry of science and technology gave the information and released an official statement about the same.The trial will be conducted in ten locations. The permission has been given to Biological E after the recommendation from the Subject Expert Committee.

 

The ministry said that the DBT and BIRAC have supported Corbevax, which is an RBD protein subunit vaccine, from the preclinical stage to Phase 3 clinical studies.

 

 

The Biological E’s vaccine candidate has also received financial support assistance under COVID-19 Research Consortia through National Biopharma Mission, BIRAC. "In addition to receiving financial assistance under Mission COVID Suraksha, this vaccine candidate has also obtained financial support under COVID-19 Research Consortia through National Biopharma Mission, BIRAC," the official release read.

 

Meanwhile, Zydus Cadila's needle-free COVID-19 vaccine ZyCoV-D has already received emergency use authorization (EUA) to inoculate children in the age group of 12-18. It is expected to be administered from the first week of October. The trials of Bharat Biotech's Covaxin COVID-19 vaccine for phases 2 & 3 for children are underway, and its result is expected in September.

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