Zydus Cadila seeks DGCI nod for emergency use of its Covid-19 vaccine for 12-18 years

Indian pharmaceutical drugmaker Zydus Cadila has applied to the Drug controller General of India (DCGI) for emergency use approval of its Covid-19 vaccine for those aged between 12-18 years, news agency Reuters reported on Thursday.

The drugmaker company presented interim results from Phase-III clinical trials in over 28,000 volunteers and the study demonstrates safety and efficiency in the interim data, the agency said. Adding that it plans to manufacture up to 12 crore doses of the shot per year.

The Phase-III clinical trial data from Zydus Cadila shows that ZyCoV-D is safe for children between 12 to 18 years of age group. The second homegrown vaccine, after Bharat Biotech’s Covaxin, the Zydus’ vaccine, is a three dose vaccine. However the company is also working on two dose vaccine.

ZyCoV-D is the fifth vaccine authorised for use in India, after Moderna, AstraZeneca and partner Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, and Sputnik V developed by Russia’s Gamaleya Institute.

Although Covid-19 cases in India declined from a devastating peak in April and May, experts warn of the third wave and reiterated that widespread vaccination is one of the best defences against the pandemic.

The DCGI had granted permission for Zydus Cadila pharmaceuticals to conduct human trials for ZyCoV-D in July 2020 and the company had said that their vaccine will hit the markets in June 2021.

The study was carried out “during the peak of the second wave of Covid-19 in India, reaffirming the vaccine’s efficacy against the new mutant strains especially the Delta variant,” Zydus said in a statement.

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