ZyCoV-D': World's first DNA-based COVID vaccine gets approval in India

World's first DNA platform-based Covid-19 vaccine has got Emergency Use Authorization (EUA) from the drug regulatory authority on Friday.

By Newsmeter Network  Published on  21 Aug 2021 3:14 AM GMT
ZyCoV-D: Worlds first DNA-based COVID vaccine gets approval in India

Hyderabad: World's first DNA platform-based Covid-19 vaccine has got Emergency Use Authorization (EUA) from the drug regulatory authority on Friday.

Manufactured by Zydus Cadila, ` ZyCoV-D' received approval from the Drug Controller General of India (DCGI) on Friday after the Subject Expert Committee recommended its emergency authorization in a meeting convened on Thursday.

ZyCoV-D has become the sixth vaccine added to a large portfolio of Covid-19 vaccines cleared in the country after locally produced `Covishield', Bharat Biotech's `Covaxin', Russia's `Sputnik V', the US-made `Moderna', and Johnsons and Johnson's `Janssen'.

Dr. Renu Swarup, Secretary, Department of Biotechnology which partnered with the Zydus to develop the vaccine said it is a matter of great pride that India produced the world's first DNA Covid-19 vaccine.

"We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our Indigenous Vaccine Development Mission and positions India on the Global Map for Novel Vaccine Development," she added.

The 3-dose regimen vaccine can be administered to adults. It is also the first vaccine that can be administered to children aged 12 and above.

Zydus conducted clinical trials for ZyCoV-D at more than 50 centers in India, making it the largest such trial in the country. The volunteers included around 1,000 children aged 12-18, the first vaccine trial for adolescents in India.

The vaccine is delivered through a needle-free applicator called the PharmaJet to ensure painless intradermal vaccine delivery. The trials, in over 28,000 volunteers, showed primary efficacy of 66.6 percent for symptomatic RT-PCR positive cases. This vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier. Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB).

Ahmedabad based pharmaceutical firm stated that it plans to manufacture 10-12 crore doses

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