COVID-19: Gennova Biopharma to start mRNA vaccine trials this month

COVID-19: Gennova Biopharma to start mRNA vaccine trials this month

The Pune-headquartered company had received approval in December last year to start phase 1 and 2 trials for its COVID-19 vaccine candidate.

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A mRNA vaccine carries molecular instructions through a synthetic RNA of the virus to make the protein that triggers an immune response in the body.A mRNA vaccine carries molecular instructions through a synthetic RNA of the virus to make the protein that triggers an immune response in the body.
BusinessToday.In
  • Apr 19, 2021,
  • Updated Apr 19, 2021 3:38 PM IST

India may soon get its first indigenous mRNA or messenger RNA COVID-19 vaccine as Gennova Biopharmaceuticals Ltd is looking to start the first phase of human trials for its vaccine this month.

The Pune-headquartered company, a subsidiary of Emcure Pharmaceuticals, had received approval in December last year to start phase 1 and 2 trials for its COVID-19 vaccine candidate. However, it got delayed as the Drugs Controller General of India (DGCI) asked the company to repeat the animal toxicity study which it had conducted in the US.

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"The DCGI cleared it in December, but we had originally submitted our pre-human animal toxicity studies from the work we had done in the US. mRNA is a brand-new technology and there's no commercial mRNA product in India. There were certain protocols and formalities to be followed, wherein they wanted us to repeat the animal toxicity studies in the Indian setting," Mint quoted Vikas Thapar, president of corporate development and strategy at Emcure Pharmaceuticals, as saying.

50% American adults receive at least 1 dose of COVID-19 vaccine

India may soon get its first indigenous mRNA or messenger RNA COVID-19 vaccine as Gennova Biopharmaceuticals Ltd is looking to start the first phase of human trials for its vaccine this month.

The Pune-headquartered company, a subsidiary of Emcure Pharmaceuticals, had received approval in December last year to start phase 1 and 2 trials for its COVID-19 vaccine candidate. However, it got delayed as the Drugs Controller General of India (DGCI) asked the company to repeat the animal toxicity study which it had conducted in the US.

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"The DCGI cleared it in December, but we had originally submitted our pre-human animal toxicity studies from the work we had done in the US. mRNA is a brand-new technology and there's no commercial mRNA product in India. There were certain protocols and formalities to be followed, wherein they wanted us to repeat the animal toxicity studies in the Indian setting," Mint quoted Vikas Thapar, president of corporate development and strategy at Emcure Pharmaceuticals, as saying.

50% American adults receive at least 1 dose of COVID-19 vaccine

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