India’s first mRNA-based Covid-19 vaccine gets DCGI nod for Phase II & III trials

The trial for India’s first mRNA-based vaccine from Gennova Biopharmaceuticals was found to be safe in Phase I study. Post Drugs Controller General of India approval, Phase II and Phase III trials are to commence in early September, 2021

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New Delhi: In a significant development towards India’s vaccination efforts, the Drug Controller General of India, has approved Phase II and Phase III study protocols for HGCO19, India’s first mRNA-based COVID-19 vaccine, developed by Gennova Biopharmaceuticals Limited.
Gennova, the subsidiary of Pune based Emcure Biopharmaceuticals had 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).
Vaccine Subject Expert Committee (SEC) reviewed the interim Phase I data, and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study.
Commenting on the development, Dr. Sanjay Singh, CEO-Gennova Biopharmaceuticals said, “The approval for Phase II and III protocol for what could be country’s first mRNA platform-based COVID-19 vaccine brings us immense satisfaction and highlights the grit of scientists unified for a common cause. The global pandemic has brought into the foray R&D that is safe, reliable, accessible and quickly available. HGCO19 was developed keeping the same objectives in mind and using the exciting possibilities of mRNA technology. We are determined to protect members of our global community from the devastating impact of the novel coronavirus.”
The study will be conducted in India at approximately 10-15 sites in Phase II and 22-27 sites in Phase III. Gennova plans to use the DBT-ICMR clinical trial network sites for this study.
mRNA vaccines present various benefits as they are non-infectious, non-integrating in nature, and degraded by normal cellular mechanisms. These are highly efficacious because of their inherent capability to be translatable into the cell cytoplasm’s protein structure, and are developed at a rate faster than traditional vaccines under the cGMP conditions.
Gennova’s mRNA-based COVID-19 vaccine development program was partly funded by the Department of Biotechnology (DBT), Government of India under Ind-CEPI, way back in June 2020. Later on, the DBT further supported the program under the Mission COVID Suraksha- The Indian COVID-19 Vaccine Development Mission, implemented by BIRAC.