Human trials for India’s first homegrown mRNA COVID-19 vaccine have been completed and the makers are in the process of submitting the data to the drug regulator, according to a report. 

The vaccine candidate is being developed by Pune-based company Gennova Biopharmaceuticals. Dr Sanjay Singh, CEO of the firm, told The Indian Express, “Phase II and III trials have been completed. We have submitted and presented Phase II data and are in the process of submission of Phase III trial data that was conducted among 4,000 participants.”

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The vaccine candidate, known as HGC019, has been created in collaboration with the US-based HDT Biotech Corporation.

COVID-19 Task Force head and Niti Aayog member Dr V K Paul had said on February 10 that the vaccine was ‘currently under final clinical trials’.

“We need the mRNA platform because it is a new platform. It has been shown that the vaccine developed on this platform for Corona has been effective worldwide. Having an India vaccine and vaccine platform available is an asset today in the wake of Covid and Omicron,” he had said during a press conference.

The Drug Controller General of India (DCGI) had approved Phase 2 and Phase 3 trials for the vaccine in August last year. 

Gennova had posted an update about the vaccine in September 2021, which read, “The Drug Controller General of India, had approved Phase II and Phase III study protocols for HGCO19, India’s first mRNA-based COVID-19 vaccine, developed by Gennova Biopharmaceuticals Limited back in August.”

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The company also plans to begin phase II trials for the vaccine among the paediatric population. Currently, India does not offer COVID-19 vaccines to those under the age of 15. However, the subject expert committee of the DCGI has now recommended granting restricted emergency use authorisation to Corbevax for the 12-18 age group, subject to conditions, news agency PTI reported citing sources. The drug regulator is expected to take up the matter in the coming days. 

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Messenger RNA technology is a revolutionary way to develop vaccines. These candidates belong to the category of nucleic acid vaccines and use genetic material from the virus to trigger an immune response. They do not contain any live components of the virus, unlike several other vaccine types. 

The COVID-19 pandemic is the first time that these have been authorised for use among humans. 

Satish Mehta, founder and CEO of Emcure Pharmaceuticals (under which Gennova is a subsidiary), told The Indian Express in an interview, “While mRNA is undoubtedly the best vaccine that we have, Pfizer and Moderna are supplying to the regulated markets. I think the rest of the world (emerging markets) would be happy to take mRNA and we see them as a market for us.”

“While Moderna and Pfizer are required to be kept at very low temperatures. The vaccine that we have developed is stable between 2 and 8 degrees and that makes the job lot easier,” he added.