Indian firm Gennova Biopharmaceuticals 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 Government of India'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.

Gennova 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.
Read more at https://www.biospectrumasia.com/news/49/18888/indias-first-mrna-bas...