The Drugs Controller General of India (DCGI) has given a go-ahead to the Phase 2/3 trials of India’s first mRNA-based COVID vaccine, HGCO19.
The vaccine has been deemed to be safe by the Vaccine Subject Expert Committee (SEC), which had reviewed the interim Phase I trial data. The committee found the vaccine to be safe, tolerable and immunogenic in the participants of the study.
HGCO19: India’s first mRNA-based vaccine
•The mRNA-based vaccine has been developed in partnership with Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC).
•Gennova Biopharmaceuticals Ltd., which is a Pune-based biotechnology company, had submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisation (CDSCO) and the Centre’s National Regulatory Authority (NRA).
•The Vaccine Subject Expert Committee had then reviewed the interim Phase I data and found HGCO19 to be safe, tolerable and immunogenic among the participants of the study.
DCGI nod for Phase 2/3 trials
Gennova had also submitted the proposed Phase II/ Phase III study titled “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.”
The study was also approved by the office of the DCGI, CDSCO. The study will be conducted at approximately 10-15 sites in India under Phase II trials and 22-27 sites in Phase III trials.
The Pune-based company plans to use the DBT-ICMR clinical trial network sites for this study.
Gennova’s mRNA-based COVID-19 vaccine development program has been partly funded by the Department of Biotechnology (DBT) way back in Jun 2020.
The Department of Biotechnology further supported the program under the Mission COVID Suraksha- The Indian COVID-19 Vaccine Development Mission, which was implemented by BIRAC.
HGCO19 is expected to be an important vaccine for both India and the world. The vaccine’s development is an important milestone in India’s Indigenous Vaccine Development Mission and positions India on the global map for novel vaccine development.