India’s 1st homegrown mRNA vax to be tested amid Omicron spike

Pune-based Genova Biopharmaceuticals has submitted Phase 2 data for mRNA vaccine and has also completed recruitment of Phase 3 data. Official sources said the Subject Expert Committee (SEC) of the Drug Controller General of India (DCGI) is likely to review the data soon.

Earlier in the month of September 2021, Genova issued a press statement and updated about the vaccine trials, “The Drug Controller General of India has approved the Phase II and Phase III study protocols for HGCO19, which is India’s first clinical trial.” The first is an mRNA-based COVID-19 vaccine, developed by Genova Biopharmaceuticals Ltd (“Genova”) back in August.” Genova submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisation (CDSCO), the National Regulatory Authority (NRA) of the Government of India. The Vaccine Subject Expert Committee (SEC) approved the Interim Phase I study. The data was reviewed, and found that HGCO19 was safe, tolerable and immunogenic in study participants,” it said.

The company also mentioned the number of trial sites, “The study in India is being conducted at approximately 10-15 sites in Phase II and 22-27 sites in Phase III. Genova DBT-ICMR Clinical Trials Network for this study.” using the sites. mRNA vaccines belong to the class of nucleic acid vaccines, which use genetic material from disease-causing viruses or pathogens to trigger an immune response against it within the body.