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June 30, 2022

HDT Bio receives Emergency Use Approval for Covid-19 vaccine in India

Gemcovac became the first saRNA vaccine to obtain approval for use in humans in India.

HDT Bio has received Emergency Use Approval from Indian regulators for its Covid-19 vaccine, Gemcovac.

The vaccine leverages self-amplifying RNA (saRNA), which can replicate itself after administration and could be effective at very low doses. 

As against other existing messenger ribonucleic acid (mRNA) vaccines that need ultra-cold storage, the Gemcovac vaccine is stable at refrigerator temperatures.

With the latest approval in India, Gemcovac became the first saRNA vaccine to obtain approval for use in humans. 

At present, the vaccine is being analysed in clinical trials in the US, Brazil and South Korea.

HDT Bio CEO Steve Reed said: “Our saRNA vaccine is a game-changer. This technology can stimulate an immune response with a dose up to 20 times lower than current vaccines, which enhances safety, lowers costs, and increases production speed. 

“The combination of lower cost and higher stability will allow HDT Bio to take a truly global distribution approach.

“This milestone is the first of our many efforts to improve global health outcomes through scientific advancement.”

In July 2020, HDT Bio announced co-development efforts with Indian firm Gennova Biopharmaceuticals to commence analysis of HDT-301 in human clinical trials. 

The companies commenced dosing healthy subjects with the Covid-19 vaccine in Phase I/II trial in India, in May last year.

This January, HDT Bio dosed the first subjects in the Phase I clinical trial of its Covid-19 vaccine, HDT-301, in Brazil. 

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