The Central Drugs Standard Control Organisation (CDSCO), India's National Regulatory Authority, has approved Gennova Biopharmaceuticals Limited's work on the country's first mRNA-based COVID-19 vaccine for its clinical data of the phase-1 study.
"Vaccine Subject Expert Committee (SEC) reviewed the interim phase-1 data and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study. The Director General (I), CDSCO, approved the proposal submitted for the phase 2 and 3 studies by Gennova Biopharmaceuticals Limited, a Pune-based biotechnology company," the Ministry of Science and Technology said in a release on Tuesday.
Gennova's study titled "A prospective, multicentre, randomized, 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" and will be conducted in India at nearly 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," the release added.
Gennova's mRNA-based Covid-19 vaccine development programme was partly funded by the Department of Biotechnology (DBT) in June 2020. Later, the DBT further supported the programme under the Mission Covid Suraksha -- the Indian Covid-19 Vaccine Development Mission -- implemented by BIRAC.
BIRAC is a not-for-profit public sector enterprise which stands for 'Biotechnology Industry Research Assistance Council' that has been set up by the DBT. It acts as an interface agency to enhance and encourage the evolving biotechnology industry to implement strategic research and development activities for the product development needs of the country.
DBT Secretary Renu Swarup, who is also the BIRAC Chairperson, said, "It is a matter of great pride that the country's first mRNA-based vaccine is found to be safe, and the Drugs Controller General of India (DCGI) has approved Phase 2/3 trial. 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."
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."
