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mRNA-Based Vaccine Gets DCGI Approval for Trials

mRNA-Based Vaccine Gets DCGI Approval for Trials

Pune-based biotechnology company Genova Biopharmaceuticals Limited, which is working on the country’s first mRNA-based Covid vaccine, has got permission for Phase 2 and 3 clinical trials. The company has completed the first phase of its vaccine trial and sent its interim results to the subject expert committee of the Central Drug Controller Standard Control Organization. The committee reviewed a data from the interim results of the first phase of the vaccine and found that the vaccine HGCO19 is safe and immunogenic. After which the second and third phase human trials have been approved.

The second phase trial of HGCO19 mRNA based Kovid 19 vaccine will be done in about 10-15 places. Whereas in the third phase, this trial will be done at 22-27 places. Genova plans to use the DBT-ICMR Clinical Trial Network sites for this study.

Genova’s mRNA-based COVID-19 vaccine development program was partly funded by the Department of Biotechnology (CEPI). Later, DBT supported the program under Mission COVID Suraksha – Indian COVID-19 Vaccine Development Mission, which was implemented by BIRAC.

On getting the approval for Phase II and III trials of the vaccine, Department of Biotechnology Secretary Dr Renu Swarup said, “It is a matter of great pride that the country’s first mRNA-based vaccine has been found to be safe and DCGI of India has completed Phase II and III.” We believe this will be an important vaccine for both India and the world. It is an important milestone in our indigenous vaccine development mission and places India on the global map of vaccine development.”

The Department of Biotechnology (DBT), under the Ministry of Science and Technology, promotes and works to improve biotechnology development in India through its development and implementation in agriculture, health care, animal science, environment and industry. . The Biotechnology Industry Research Assistance Council (BIRAC), a non-profit public sector enterprise set up by the Department of Biotechnology, Government of India, acts as an interface agency to promote and promote the growing biotechnology industry. .

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