DCGI approves India’s maiden mRNA vaccine against COVID-19

Gennova Biopharma announced that its mRNA vaccine – Gemovac-19 – against COVID-19 has received the Emergency Use Authorisation (EUA) from the office of the Drugs Controller General of India (DCGI).

Gemovac-19 is the first mRNA vaccine developed in India and only third mRNA vaccine to be approved for COVID-19 in the world. These vaccines are highly efficacious because of their inherent capacity of being translated into the protein structure inside the cell cytoplasm. mRNA vaccines are considered safe as mRNA is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms. Notably, this technology provides flexibility to quickly tweak the vaccine for any existing or emerging variants of the virus and this technology platform will empower India to be pandemic-ready.

Gennova’s Gemovac-19 has reached the primary end point of the phase-III clinical trial. The clinical data was evaluated by the Central Drugs Standard Control Organisation (CDSCO). The vaccine was found to be safe, well-tolerated and immunogenic.