Clinical Trials On India's First mRNA Covid-19 Vaccine To Be
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The clinical trial of India’s first messenger RNA (mRNA)-based Covid vaccine is set to kick off this month after a delay of six months after Pune-based Gennova Biopharma received the necessary regulatory permissions to start the trials in the country. According to the company, it is expected to inject the first participant with the vaccine on April 19.

Currently, the two mRNA vaccines that are under use for Covid-19 are by US drug makers Pfizer and Moderna and have shown to have over 90% efficacy in preventing Covid-19 infection. The effectiveness study from the real-world setting shows that the vaccine has cut down hospitalisations and infections, studies showed.

The mRNA vaccines are considered a fourth-generation vaccine platform because unlike traditional vaccine platforms that use the dead or inactivated virus particle, the mRNA carries the molecular instructions to make the protein in the body through a synthetic RNA of the virus. The host body uses this to produce the viral protein that is recognised by the immune system, which creates antibodies, making the body ready to fight against the disease.

Therefore, these vaccine platforms are considered to be the safest. They can also be quickly remodeled to cater to the emerging variants of a pathogen. In the randomised phase-1/ 2 trial involving 620 participants, Gennova will evaluate the safety, tolerability, and immunogenicity of the vaccine in healthy adults in the age group of 18-70 years. The vaccine codenamed HGCO19 will be given in two doses 28 days apart.

In phase 1, it will study the safety of the vaccine in 120 participants and phase-2 study will enroll approximately 500 participants. It plans to create a one-billion annual dose manufacturing facility by tapping into the specialised nano-particle manufacturing capacity of its parent firm Emcure Pharma.

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