India grants approval to ZyCoV-D, first ever DNA based COVID-19 vaccine

INDIA – The world’s first DNA-plasmid vaccine, the three-dose one for Covid-19 developed by Cadila Healthcare (Zydus Cadila), has received emergency-use authorization from the Drugs Controller General of India (DCGI) for use in adolescents 12 years old and above.

It is a matter of great pride that today we have EUA for the world’s first DNA Covid-19 vaccine, ZyCoV-D, by Zydus, developed in partnership with the Department of Biotechnology and supported through Mission COVID Suraksha,” Renu Swarup, secretary, department of biotechnology, and chairperson, Biotechnology Industry Research Assistance Council, said.

This makes indigenously developed ZyCoV-D India’s first Covid-19 vaccine for this age group, and the vaccine has many firsts.

It is based on DNA-plasmid technology; then, it can be administered using a needle-free injection system; and finally, it remains stable in room temperatures for three months.

A DNA-plasmid vaccine is a relatively new approach where a piece of DNA containing the genes for the antigens is injected.

The body then learns to develop an immune response against the antigen, and when the pathogen attacks, the body is able to generate the specific antibodies against it.

DNA vaccines, Zydus has said, have been shown to stimulate sustained immune responses. This is a three-dose vaccine whose second and the third doses are 28 and 56 days, respectively, after the first.

Meanwhile, Zydus has submitted immunogenicity data from a two-dose regimen (using 3 mg doses) trial to the DCGI. The data shows “equivalent immunogenicity” with that of the three-dose regimen. Therefore, a two-dose regimen approval is also expected.

The interim results from Phase-3 clinical trials in over 28,000 volunteers showed primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases. Zydus has so far invested Rs 400-500 crore in developing ZyCoV-D. It includes setting up manufacturing plants.

Zydus has also said its vaccine works against the Delta variant as the trials carried out in more than 50 clinical sites spread across the country and during the peak of the second wave of Covid-19 have shown the vaccine’s efficacy against the new mutant strains, especially the delta variant.

Typically, in a needle-free injection system, a jet of fluid is accelerated to high speed, providing it significant penetrating power through a fine-diameter nozzle when placed against the skin.

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