India’s first mRNAbased vaccine moves into Phase II/III trial

Pune-based Gennova Biopharmaceuticals, working on the nation’s first mRNA-based COVID-19 vaccine, recently submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisation (CDSCO), the Government of India’s National Regulatory Authority (NRA). 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 has submitted the proposed Phase

II and Phase III study entitled “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. Gennova plans to use the DBT-ICMR clinical trial network sites for this study.