DGCI gives nod to Biological E to conduct phase 2/3 clinical trials

In a step ahead for the immunisation of children against coronavirus pandemic, the Drugs Controller General of India (DCGI) has granted permission to Biological E Limited to conduct phase 2/3 clinical trials of its COVID-19 vaccine on children aged between 5 and 18 years with certain conditions, sources said.

India’s drug regulator gave the green signal to Biological E Limited to conduct phase 2/3 clinical trials of its ‘Made in India’ COVID-19 vaccine after the recommendations by the Subject Expert Committee (SEC) on COVID-19.

Corbevax vaccine, developed by Biological E, is a RBD protein sub-unit vaccine. It is currently undergoing phase 2/3 clinical trials on adults.

The three-dose vaccine which when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from disease as well as viral clearance. The plug-and-play technology on which the plasmid DNA platform is based can be easily adapted to deal with mutations in the virus, such as those already occurring.

As of now, only Zydus Cadila has received Emergency Use Authorisation from the DGCI for its ZyCoV-D vaccine to be administered in the age group of 12-18 years in India. Notably, the indigenously developed Zydus Cadila’s COVID-19 vaccine is needle-free. It is the world’s first and India’s indigenously developed DNA based vaccine for COVID-19 to be administered in humans including children and adults 12 years and above.

Meanwhile, the data study of phase 2/3 clinical trials of Bharat Biotech’s Covaxin in the age group 2 to 18 years is underway and it is expected to be launched in October-November.

In July, the DCGI had granted permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years. Currently, SII is providing Covishield vaccine doses in India. Times Now