India’s first indigenous mRNA vaccine Gemcovac-19 likely to be available soon

Gennova Biopharmaceuticals, a subsidiary of Emcure Pharmaceuticals, announced that its mRNA – Gemcovac-19 – against Covid-19 received the Emergency Use Authorization (EUA) from the office of the Drugs Controller General of India (DCGI).

Gemcovac-19 is the very first mRNA developed in India and only third mRNA to be approved for COVID-19 in the world.

Gennova Biopharmaceuticals Ltd aims to produce around 4 – 5 million doses per month and this capacity can be quickly doubled.

Apart from India, Gennova aims to provide access to low-and middle-income countries around the world to the vaccine to blunt the spread of pandemic.

Also Read: Covid vaccines prevented 20 million deaths in first year of rollout: Study

“These vaccines are highly efficacious because of their inherent capacity of being translated into the protein structure inside the cell cytoplasm,” the company said in its statement .

mRNA vaccines are considered safe as mRNA is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms, Gennova claimed.

Further, this technology provides flexibility to quickly tweak the vaccine for any existing or emerging variants of the virus.

“Gennova’s Gemcovac-19 has reached the primary end-point of the Phase III clinical trial. The clinical data was evaluated by the Central Drugs Standard Control Organisation (CDSCO). The vaccine was found to be safe, well-tolerated and immunogenic,” Gennova said.

Last week, the expert panel advising the Central Drugs Standards Control Organisation (CDSCO) green-signalled Gennova Biopharma’s mRNA vaccine candidate for Covid-19.

Gennova’s vaccine has an edge over its international peers as it does not require sub-zero temperatures like Pfizer-BioNTech and Moderna’s vaccines.

NK Arora, head, Covid-19 working group, NTAGI, had earlier told Business Standard that the company would consider the indigenous mRNA vaccine for inclusion in India’s ongoing national programme for Covid-19 vaccination.

The vaccine, however, is embroiled in controversies. US firm HDT Bio Corp has filed a lawsuit in a Seattle federal court against Gennova’s parent company Emcure Pharmaceuticals. HDT has accused Emcure of ‘stealing’ and misappropriation of HDT’s billion dollar trade secrets and sought $950 million in damages. The US firm has alleged that Emcure ‘willfully and maliciously’ violated the Defend Trade Secrets Act and Washington’s laws against trade secret theft.

Legal experts feel that the reliefs requested by HDT are primarily monetary in nature and not aimed at inducing any form of injunctions.

The lawsuit in a Seattle court by a US-based start-up may not immediately impact the launch of Pune-based Gennova Biopharmaceuticals’ mRNA vaccine once the vaccine receives the Indian regulator’s nod, feel legal experts. The long term prospects of the vaccine may depend on how the case progresses

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