DCGI finds first mRNA vaccine safe, gives nods for Phase 2/3 trials

New Delhi, Aug 27 (IANS) The Drug Controller General of India has approved the Phase 2 and 3 clinical trials of India's first Covid-19 mRNA vaccine.

Pune-based pharma major Gennova Biopharmaceuticals Ltd is developing the nation's first mRNA-based Covid-19 vaccine. It is among a few pharmaceutical firms worldwide, including Moderna Inc and Pfizer Inc, to use 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.

"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 Central Drugs Standard Control Organisation (CDSCO), the Government of India's National Regulatory Authority (NRA). 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.

Gennova submitted the proposed Phase 2 and 3 study titled 'A Prospective, Multicentre, Randomised, 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 DCGI, CDSCO.

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. The host body produces the viral protein that is recognised by the immune system, thereby enabling the body to fight against the disease. mRNA vaccines are considered safe as mRNA is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms. They are highly efficacious because of their inherent capability of being translated into proteins in the cell.