India’s First mRNA Vaccine: DCGI Approves Phase 2/3 Clinical Trials

Gennova Biopharmaceuticals Ltd., (an Emcure group of companies), a Pune-based biotechnology company that has been working on the nation’s first mRNA-based COVID-19 vaccine, The Indian Express (TIE) reported.

The firm 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).

In a statement, Dr Renu Swarup, Secretary, DBT and Chairperson, Biotechnology Industry Research Assistance Council (BIRAC) was quoted as saying, “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 has approved Phase 2/3 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.”