CEO of Gennova had said that the company’s current manufacturing capabilities can produce up to 200 million doses a year

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 necessary regulatory permissions to start the trials in the country. According to the company’s filings with clinical trial registry that ET has seen, 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 done in Israel showed.

The mRNA vaccines are considered 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 remodelled 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 enrol approximately 500 participants.

In an interview with ET in July 2020, Sanjay Singh, CEO of Gennova, had said that with the company’s current manufacturing capabilities, it can produce up to 200 million doses a year.

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.

There is a possibility that the company might seek emergency approval from the drug regulators within four months based on data from other mRNA vaccines that have shown co-relates of protection or functional immune response to the vaccine. “When Covaxin can get an approval on the basis of safety, why not an mRNA vaccine that has shown to be most safe till now,” said an official aware of the development who did not wish to be quoted.