Gennova Biopharmaceuticals’ mRNA-based COVID-19 vaccine has submitted the interim clinical data of the phase-I study to the Central Drugs Standard Control Organisation (CDSCO).
The Vaccine Subject Expert Committee (SEC) reviewed the interim phase-I data and found that HGCO19 was safe, tolerable and immunogenic in the participants of the study.
Gennova submitted the proposed phase-II and phase-III study entitled, “A prospective, multi-centre, randomised, 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 DCG(I), CDSCO.
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.
Gennova’s mRNA-based COVID-19 vaccine development programme was partly funded by the Department of Biotechnology (DBT), under Ind CEPI, way back in Jun 2020. Later on, the DBT further supported the programme under the Mission COVID Suraksha-The Indian COVID-19 Vaccine Development Mission, implemented by BIRAC.
Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC, said, “It is a matter of great pride that nation’s first mRNA-based vaccine is found to be safe and the Drugs Controller General of India DCG(I) has approved phase-II/III 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.”
Adding to it, Dr Sanjay Singh, CEO, Gennova Biopharmaceuticals, said, “After establishing the safety of our mRNA-based COVID-19 vaccine candidate HGCO19 in phase-I clinical trial, Gennova’s focus is to start phase-II/III pivotal clinical trial. In parallel, Gennova is investing in scaling up its manufacturing capacity to cater to the nation’s vaccine requirement.