Gennova Biopharma phase III trials of mRNA-based Covid vax to end in January

Gennova is the first Indian pharma company to develop an indigenous mRNA platform and the company has been working on this platform for the past four years.

Gennova Biopharmaceuticals, a subsidiary of Pune-based Emcure Pharmaceuticals, is nearing completion of its phase II-III trials of their mRNA-based Covid-19 vaccine. Samit Mehta, president, Emcure, said they were expecting to complete trials in January 2022. The company has applied for manufacturing and stock piling of the vaccines at risk, Mehta said.

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Gennova is the first Indian pharma company to develop an indigenous mRNA platform and the company has been working on this platform for the past four years.
The government had expected the company to launch the vaccine this month and had estimated to get 60 million doses of Gennova’s mRNA vaccine by December. There have been challenges in getting volunteers. “We had started Phase I trials right in the peak of the second wave. We needed sero negative volunteers, someone who was not exposed, which was tough to find. So it took a little bit of time. We had only two centres at that time. We have learnt from that experience and Phase III, we have 35 centres so the pace of recruitment has been faster,” Mehta said.

Gennova was also working on the freeze drying technology that enables storage of their mRNA vaccine at 2 degrees to 7 degrees Celsius. The other mRNA vaccines available globally need to be store and minus 20 degrees which is not suitable for India or emerging countries, Mehta said. The vaccines would also cost lower that the existing global vaccines, he said.

With the new Omicron variant emerging and efficacy of existing vaccines against the variant unclear, the company would be looking at the demand for booster doses. The company has started looking at this internally and the government is also pushing us to look at it, Mehta said. Global data suggests that mRNA vaccines being effective booster doses and also safe for pediatric vaccination, he said. This will follow once the basic vaccine is approved.

Once the Indian Emergency Use Authorization comes, the company would also look at a World Health Organization listing as protocol is designed such a way that WHO mandates so it could expedite the process.

Vik Thapar, president, corporate development and strategy, Emcure, said, globally opportunity for the Covid-19 vaccine still exists as many countries have only vaccinated 5-10% of their population so the market will be there for the vaccine. The focus is to get the emergency use authorisation done and that will open up the market, Thapar said. The mRNA vaccine can be tweaked to deal with new mutations and spikes like the Omicron in a short period of time compared to the other vaccines, Thapar said. Companies like ours will have a role to play even if the pandemic becomes endemic, he said. Booster dose, pediatric dose and mix and match of doses would only need a small bridging study, Thapar said.

The Drug Controller General of India had approved Phase II and Phase III study the vaccine in August. Gennova will submit the data to the DCGI and then it will be decided by the Vaccine Subject Expert Committee.

Emcure has repurposed vaccine manufacturing capacity to make the mRNA Covid-19 vaccines. It has an installed capacity to make 200 million doses that can be scaled up to one billion doses. Gennova has invested around Rs 500 crore in the project including Rs 125-crore funding from the government as seed capital and for conducting trials.