Zydus Cadila seeks DCGI nod for emergency use of its DNA vaccine for 12+ age

Zydus Cadila has planned to annually manufacture 100-120 million doses of ZyCoV-D, its DNA-based Covid-19 vaccine.


Gujarat-based pharmaceutical company Zydus Cadila has applied to the Drugs Controller General of India (DCGI), India's top drug regulator, seeking emergency use approval of ZyCoV-D, its DNA vaccine against coronavirus disease (Covid-19) for those aged 12 years and above, news agencies reported on Thursday. The company presented interim results from Phase-III clinical trials in over 28,000 volunteers, Reuters said, adding that the study demonstrates safety and efficacy in the interim data.

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The DCGI had granted Cadila Healthcare Limited permission to conduct human trials for ZyCoV-D back in July last year, when the company had said that its vaccine will hit the markets by June 2021. Earlier, the pharmaceutical company was in the news for being one of the several Indian firms which received licensing agreements from Gilead Sciences to produce the anti-viral drug remdesivir.

The Phase-III clinical trial data from Zydus Cadila shows that Zycov-D is safe for children in the age group of 12 to 18 years. The company has planned to manufacture 100-120 million doses of Covid-19 vaccines annually.

source -ht

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