Gennova Biopharmaceuticals Ltd (GBL), 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 union government’s National Regulatory Authority (NRA).
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, the Union Ministry of Science & Technology said.
GBL submitted the proposed phase-II and phase-III study, ‘A Prospective, Multicentre, 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 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. The company 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), the Government of India under Ind CEPI 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.
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.”
Dr Sanjay Singh, CEO, GBL, said, “After establishing the safety of our mRNA-based Covid -19 vaccine candidate HGCO19 in the 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.