India’s first homegrown messenger RNA, or mRNA vaccine, is expected to go under trials in February, official sources have said.

Data from phase 2 trials of the COVID vaccine, developed by the Pune-based Gennova Biopharmaceuticals, is expected to be reviewed by the Subject Expert Committee (SEC) of the Drugs Controller General of India (DCGI), news agency ANI reported, quoting sources.

A variant-specific version of the vaccine has also been developed to tackle the highly contagious omicron variant of the coronavirus, which is considered responsible for the recent COVID waves.

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

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.”

“Gennova had submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisation (CDSCO), the Government of India’s National Regulatory Authority (NRA). The Vaccine Subject Expert Committee (SEC) had reviewed the interim Phase I data, and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study,” it added. 

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Phase 2 of the study was conducted over 10-15 trial sites, while phase 3 will be conducted in 22-27 sites. Gennova is using the DBT-ICMR clinical trial network sites for this study, the company said.

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. 

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

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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.