India's first mRNA-based COVID-19 vaccine candidate HGCO19 by Gennova Biopharmaceuticals Ltd has been granted approval for Phase 2/3 clinical trials, the Department of Biotechnology (DBT) said on 24 August.

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The Pune-based biotechnology company had submitted the interim clinical data of the vaccine's Phase 1 study to the Central Drugs Standard Control Organisation (CDSCO), it said. The Vaccine Subject Expert Committee (SEC) reviewed the interim Phase 1 data and found that the HGCO19 vaccine was safe, tolerable, and immunogenic in the participants of the study.

"Gennova submitted the proposed phase 2 and phase 3 study entitled 'A prospective, multicentre, randomised, active-controlled, observer-blind, phase 2 study seamlessly followed by a phase 3 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 DCG(I), CDSCO," the DBT said. The study will be conducted in the country at approximately 10-15 sites in Phase 2 and 22-27 sites in Phase 3. Gennova plans to use the DBT-ICMR clinical trial network sites for this study, it said. 

Later on, the DBT further supported the programme under 'Mission COVID Suraksha The Indian COVID-19 Vaccine Development Mission', implemented by BIRAC. Renu Swarup, Secretary of DBT and Chairperson of Biotechnology Industrial Research Assistance Council (BIRAC), said this is an important milestone in the country's indigenous vaccine development mission, and it positions India on the global map for novel vaccine development.

Sanjay Singh, CEO of Gennova Biopharmaceuticals Ltd, said, "After establishing the safety of our mRNA-based COVID-19 vaccine candidate HGCO19 in Phase 1 clinical trial, Gennova's focus is to start Phase 2/3 pivotal clinical trial. "In parallel, Gennova is investing in scaling up its manufacturing capacity to cater to the nation's vaccine requirement," he said.