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Country’s first mRNA vaccine safe, DCGI gives nod for phase 2/3 clinical trials

Gennova Biopharmaceuticals Ltd., (an Emcure group of companies) is a Pune-based biotechnology company that has been working on the nation’s first mRNA-based Covid-19 vaccine.

The study will be conducted in India at approximately 10-15 sites in Phase II and 22-27 sites in Phase III.

India’s first Covid-19 mRNA vaccine was found to be safe and given the go-ahead from the Drug Controller General of India to move into the phase 2/3 clinical trials.

Gennova Biopharmaceuticals Ltd., (an Emcure group of companies) is a Pune-based biotechnology company that has been working on the nation’s first mRNA-based Covid-19 vaccine.

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).

“We had enrolled 82 participants across three trial sites (two in Pune and one in Kolhapur) in the Phase I trial that has been completed. Safety data was good enough and approval has been given for phase 2/3 trial which is expected to begin in the next two weeks,” Dr Sanjay Singh, CEO of Gennova Biopharmaceuticals Ltd told The Indian Express.

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The 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.

Gennova submitted the proposed Phase II and Phase III study — A Prospective, Multicentre, Randomized, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability, and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy subjects — which was approved by the office of the DCG(I), CDSCO.

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. “We hope to enrol 4,400 participants,” Dr Singh said.

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The vaccine development programme was partly funded by the Department of Biotechnology (DBT), Govt of India under Ind CEPI back in Jun 2020. Later on, the DBT further supported the programme under the Mission Covid Suraksha — The Indian Covid-19 Vaccine Development Mission, implemented by BIRAC.

“We are aiming to roll out the vaccine as early as possible, maybe by year-end and initially it will be for adults,” Dr Singh said. Gennova is investing in scaling up its manufacturing capacity to cater to the nation’s vaccine requirement, he added.

In a statement, Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, “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.”

First published on: 24-08-2021 at 05:51:44 pm
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