“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 interim Phase I data was examined by the Vaccine Subject Expert Committee, and concluded that HGCO19 was safe, acceptable, and immunogenic in the study’s participants.
According to the ministry, “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”.
According to the authorities, the research would be performed in India at about 10-15 sites in phase II and 22-27 sites in phase III. According to the ministry, for this investigation, Gennova intends to employ the DBT-ICMR clinical trial network sites. According to Renu Swarup, secretary of the department of biotechnology, “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”. She expressed confidence and hope in the new vaccine. She added, “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”.
