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 DCGI granted emergency use authorisation to ZyCov-D, a three-dose coronavirus vaccine developed by pharmaceutical company Zydus Cadila. This is the first Covid-19 vaccine in India that can be administered to children above 12 years of age.
The other vaccines that have received emergency use approval in India are Bharat Biotech’s Covaxin, Serum Institute of India’s Covishield, Russia-made Sputnik V and shots developed by United States-based Moderna and Johnson & Johnson.
The cumulative vaccine doses administered to beneficiaries in the country till Friday has crossed 67 crore, the health ministry said in a statement. Over 74 lakh doses were administered in the last 24 hours, it added.
India has now inoculated more than half of its adult population with at least one dose of the vaccine, while 16% have received both the doses, the government has said.