NEW DELHI (The CONNECT) The Vaccine Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) found that the nation’s first mRNA-based COVID-19 vaccine is safe, tolerable, and immunogenic among the participants of the trials.
mRNA vaccines are a new type of vaccine to protect against infectious diseases. To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies. Not mRNA vaccines. Instead, they teach our cells how to make a protein—or even just a piece of a protein—that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies, according to CDC of the US.
Gennova Biopharmaceuticals Ltd., the Pune-based biotechnology company, working on the vaccine, submitted the interim clinical data of the Phase I study to CDSCO, the Government of India’s National Regulatory Authority (NRA).
Dr. Renu Swarup, Secretary, DBT and Chairperson, Biotechnology Industry Research Assistance Council (BIRAC), said that “It is a matter of great pride that Nation’s first mRNA-based vaccine is found to be safe and the Drugs Controller General of India DCG(I) has approved Phase II/III trial. We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our Indigenous Vaccine Development Mission and positions India on the Global Map for Novel Vaccine Development.”
Dr. Sanjay Singh, CEO of Gennova Biopharmaceuticals Ltd., said that “After establishing the safety of our mRNA-based COVID-19 vaccine candidate HGCO19 in Phase I clinical trial, Gennova’s focus is to start Phase II/III pivotal clinical trial. In parallel, Gennova is investing in scaling up its manufacturing capacity to cater to the nation’s vaccine requirement.