India 12. Approved 3-dose ZyCoV-D of Zydus for children older than

New Delhi, August 20

drug regulator of india Drug Controller General of India (DCGI) On Friday, Zydus Cadila approved a three-dose COVID-19 DNA vaccine for emergency use in adults and children over the age of 12.

Developed and implemented by BIRAC in partnership with Department of Biotechnology, Government of India under ‘Mission COVID Suraksha’, NS Plasmid DNA-based ZyCoV-D is the world’s first DNA-based vaccine developed by an Indian company.

NS The Ministry of Science and Technology said in a press release that Interim results from Phase III clinical trials in over 28,000 volunteers showed an efficacy of 66.6 percent for symptomatic RT-PCR positive cases.

“This has been the largest ever vaccine trial in India for COVID-19. This vaccine has already demonstrated strong immunogenicity and tolerability and safety profile in previously conducted adaptive phase I/II clinical trials. Both Phase I/II and Phase III clinical trials have been monitored by an independent Data Security Monitoring Board (DSMB), the press release said.

The Ahmedabad-based pharma major had applied for Emergency Use Authorization (EUA) with DCGI for the vaccine on July 1.

The company said that it has conducted the largest clinical trial for the vaccine so far in more than 50 centers in India.

It has become the sixth vaccine approved for use in India after Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V and US-made Moderna and Johnson & Johnson.

The plasmid DNA-based ZyCoV-D is to be administered intraperitoneally using a needle-free injector.


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