The Drug Controller General of India (DCGI) has approved the Phase 2 and 3 clinical trials of India’s first Covid-19 mRNA vaccine proposed to be developed by Pune-based pharma major Gennova Biopharmaceuticals Ltd.
Presently, a few pharmaceutical firms worldwide, including Moderna Inc and Pfizer Inc, are using mRNA technology in its coronavirus shot.
These vaccines do not use a live virus to generate an immune response but prompt the human body to make a protein that triggers one.
The Gennova, in collaboration with HDT Bio Corp, Seattle, US, has worked together to develop an mRNA vaccine since the first report of the SARS-CoV-2 genome was published. The interim clinical data of the Phase 1 study was submitted to the DCGI. The Vaccine Subject Expert Committee (SEC) reviewed the data, and found HGCO19 to be safe, tolerable, and immunogenic in the participants of the study, said the company in a statement.
The company submitted the proposed Phase 2 and 3 study 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 DCGI.
The Phase 1 study data has been evaluated and Phase 2 will commence soon. The phase 2/3 study will be conducted in India at 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.
The vaccine development programme was partly funded by the Department of Biotechnology (DBT) under Ind CEPI back in June 2020. Later on, the DBT further supported the programme under the Mission Covid Suraksha. mRNA vaccines carry the molecular information to make the protein in the host using the synthetic RNA of the virus.