New Delhi: In a major breakthrough, India’s first mRNA-based COVID vaccine candidate HGCO19 by Gennova Biopharmaceuticals Ltd has been granted approval for Phase 2/3 clinical trails. This was informed by the Department of Biotechnology (DBT) on Tuesday. As per reports, 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 (CDSCO).Also Read - Delhi Unlock Guidelines: Marriage Parties Allowed With 100 People | What’s Allowed, What’s Not
The Department of Biotechnology further said that the Vaccine Subject Expert Committee (SEC) reviewed the interim Phase 1 data and found that the HGCO19 vaccine was safe, tolerable, and immunogenic in the participants of the study. Also Read - WHO's Approval For Bharat Biotech's Covaxin Likely This Week: Sources
“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 DCG(I), CDSCO,” the DBT said. Also Read - Ganesh Pandal in Hyderabad Promotes COVID-19 Vaccination
The department also stated that the study will be conducted in the country 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.
It must be noted that the Gennova’s mRNA-based COVID-19 vaccine development programme was partly funded by the DBT under Ind CEPI in June 2020.
Later on, the DBT further supported the programme under ‘Mission COVID Suraksha The Indian COVID-19 Vaccine Development Mission’, implemented by BIRAC.
Last week, India also granted approval for emergency use for domestically developed COVID-19 shots made by Zydus Cadila.
As per updates, the clinical trials of Gennova’s vaccine candidate began in December last year and are partly funded by the biotechnology department of India’s Ministry of Science and Technology.