NEW DELHI, Aug. 24 (Xinhua) -- The Indian drug regulator, the Drugs Controller General of India (DCGI), on Tuesday granted approval for phase II and III clinical trials of the country's first mRNA COVID-19 vaccine candidate -- HGCO19, officials said.
The vaccine is being developed by Gennova Biopharmaceuticals in partnership with the department of biotechnology and Biotechnology Industry Research Assistance Council (BIRAC) under the mission COVID-19 suraksha (protection).
"Gennova Biopharmaceuticals Limited, the Pune-based biotechnology company, working on the nation's first mRNA-based COVID-19 vaccine, submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisation (CDSCO) ...," the federal ministry of science and technology said in a statement.
The Vaccine Subject Expert Committee reviewed the interim Phase I data and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study, it added.
"Gennova submitted the proposed Phase II and Phase III study entitled -- A Prospective, Multicenter, Randomized, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability, and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy subjects, which was approved by the office of the DCGI, CDSCO," the ministry said.
The officials said the study will be conducted in India at approximately 10-15 sites in phase II and 22-27 sites in Phase III.
Gennova plans to use the DBT-ICMR clinical trial network sites for this study, the ministry said.
"It is a matter of great pride that the nation's first mRNA-based vaccine is found to be safe and the DCGI has approved Phase II, III trial," Renu Swarup, secretary of the department of biotechnology, said.
"We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our indigenous vaccine development mission and positions India on the Global Map for novel vaccine development," Swarup noted.