Covid-19: Biological E gets DCGI approval to conduct phase 2, 3 vaccine trials on children

The Drugs Controller General of India has granted approval to vaccine maker Biological E to conduct phase two and phase three clinical trials of its Covid-19 vaccine candidate Corbevax, the Union Ministry of Science and Technology announced on Friday.

The DCGI has allowed the trial to be conducted on children above 5 years of age. The trial will assess whether the vaccine is safe and produces an immune response. It will also examine the adverse effects of the vaccine, and the extent to which the participants can tolerate them.

The Hyderabad-based company has also received approval to conduct phase three trials in adults. The approval came after a subject expert committee reviewed data from the phase 1 and phase 2 clinical trials.

Corbevax is an RBD protein sub-unit vaccine that was developed with the support of the Union government’s Department of Biotechnology and public sector unit Biotechnology Industry Research Assistance Council.

“We are grateful to BIRAC [Biotechnology Industry Research Assistance Council] for their support and we are enthused that these approvals would help support our subsequent filings with WHO [World Health Organization] as well,” Biological E Managing Director Mahima Datla said.

On Thursday, NITI Aayog member VK Paul told ANI that Biological E was likely to launch Corbevax in India in October.

Last month, the…

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