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Gennova gets DCGI nod for Phase 2, 3 trials of its mRNA COVID vaccine

By - Ruchika Sharma
Published On 2021-08-25 06:58 GMT   |   Update On 2021-08-25 13:13 GMT

New Delhi: India's first mRNA-based Covid-19 vaccine candidate HGCO19 by Gennova Biopharmaceuticals Ltd has been granted approval for phase 2/3 clinical trials, the department of biotechnology (DBT) said on Tuesday. The Pune-based biotechnology company had submitted the interim clinical data of the vaccine's phase 1 study to the central drugs standard control organisation, it said.The...

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New Delhi: India's first mRNA-based Covid-19 vaccine candidate HGCO19 by Gennova Biopharmaceuticals Ltd has been granted approval for phase 2/3 clinical trials, the department of biotechnology (DBT) said on Tuesday.

The Pune-based biotechnology company had submitted the interim clinical data of the vaccine's phase 1 study to the central drugs standard control organisation, it said.

The vaccine subject expert committee reviewed the interim phase 1 data and found that the HGCO19 vaccine was safe, tolerable, and immunogenic in the participants of the study.
"Gennova submitted the proposed phase 2 and phase 3 study entitled 'A prospective, multicentre, randomised, active-controlled, observer-blind, phase 2 study seamlessly followed by a phase 3 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 DCGI, CDSCO," the DBT said.
The study will be conducted at approximately 10-15 sites in phase 2 and 22-27 sites in phase 3. Gennova plans to use the DBT-ICMR clinical trial network sites for this study, it said.
Gennova's mRNA-based Covid-19 vaccine development programme was partly funded by the DBT.
Read also: Pfizer COVID vaccine Comirnaty gets full USFDA approval




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Article Source : PTI

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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