India's First mRNA COVID-19 Vaccine Specific For Omicron Variant Could Go Into Human Trials Soon

Pune-based Gennova Biopharmaceuticals which has been developing India's first mRNA COVID-19 vaccine has submitted phase 2 data of its candidate HGCO19 and has also completed the recruitment of phase 3 data.

Drugs Controller General of India's (DCGI) Subject Expert Committee (SEC) is expected to review the data soon.

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Gennova Biopharmaceuticals has also developed the mRNA vaccine for the Omicron variant that will be tested on humans for efficacy and immunogenicity starting in February.

mRNA vaccines belong to the category of nucleic acid vaccines, which use genetic material from disease-causing virus or pathogen to trigger an immune response against it within the body.

Gennova had developed an mRNA vaccine candidate (HGCO19) in collaboration with HDT Biotech Corporation, Seattle, USA.

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In September 2021, Gennova issued a press statement and updated about the vaccines trials, "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 ("Gennova") 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 said.

If approved, Gennova will become only the third drug maker in the world and the first in India to develop an mRNA vaccine against COVID-19, the other two being Pfizer and Moderna.

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Messenger RNA vaccines ¡ª also called mRNA vaccines ¡ª are a new type of vaccine.

Unlike in the conventional method where vaccines put a weakened or inactivated germ into our bodies to trigger an immune response, mRNA vaccine teaches our cells how to make a protein¡ªor even just a piece of a protein¡ªthat triggers an immune response inside our bodies.

Other than the mRNA vaccine, which is one of the rarest globally, India had also developed the first DNA-based jab against COVID-19.

ZyCoV-D, developed by Zydus Cadila which is administered into the skin without an injection was the world's first DNA vaccine against COVID-19.

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This comes at a time when COVID-19 vaccine-makers are rushing against time to tweak their existing drug to fight against Omicron.

Pfizer Inc said last week that a redesigned COVID-19 vaccine that specifically targets the Omicron variant could be ready to launch by March.

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