Wednesday, January 19, 2022

India’s first mRNA-based COVID-19 vaccine gets DCGI nod to move into Ph-2 & Ph-3 trial

India’s first mRNA-based COVID-19 vaccine has received a nod from the Drugs Controller General of India (DCGI) to move into Phase-2 and Phase-3 trial.

Gennova Biopharmaceuticals Ltd which is the Pune-based biotechnology company is working on the mRNA-based COVID-19 vaccine- HGCO19.

It submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisation (CDSCO) which is the Government of India’s National Regulatory Authority (NRA).

Ministry of Science and Technology in a statement said that the vaccine Subject Expert Committee reviewed the interim Phase- I data and found that HGCO19 vaccine is safe, tolerable, and immunogenic.

The vaccine is being developed in partnership with Department of Biotechnology (DBT)-Biotechnology Industry Research Assistance Council (BIRAC) under Mission Covid Suraksha.

Secretary , Department of Biotechnology, Dr. Renu Swarup said that it is a matter of great pride that Nation’s first mRNA-based vaccine is found to be safe and the Drugs DCGI has approved Phase -2 and Phase-3 trial.

She said, this will be an important vaccine for both India and the world. She said, this is an important milestone in country’s Indigenous Vaccine Development Mission and positions India on the Global Map for Novel Vaccine Development.

Dr. Sanjay Singh, CEO of Gennova Biopharmaceuticals, said that after establishing the safety of mRNA-based COVID-19 vaccine in Phase- I clinical trial, the focus is to start the second and third pahse clinical trial.

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