Published in: The Business Standard
Date: 12 July, 2021

Emergency use approval for ZyCoV-D is likely to take a few more days, said sources

The company has sought emergency use approval of ZyCoV-D, its DNA vaccine against Covid-19 for those aged 12 years and above, from DCGI

A vaccine against the coronavirus disease (Covid-19) for children that is being developed by Gujarat-based pharmaceutical company Zydus Cadila may not be available soon as emergency approval from the country’s top drug regulator is likely to take a few more days.

On July 1, the company had sought emergency use approval of ZyCoV-D, its DNA vaccine against Covid-19 for those aged 12 years and above, from the Drugs Controller General of India (DCGI). It had presented interim results from Phase-III clinical trials in over 28,000 volunteers. The study is said to have demonstrated safety and efficacy in the interim data.

The data has shown that ZyCoV-D is safe for children in the age group of 12 to 18 years, said the company, which is planning to manufacture 100-120 million doses of the vaccine annually.

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.

The second indigenous jab after Bharat Biotech’s Covaxin, ZyCoV-D is a three-dose vaccine. According to Zydus Cadila, the three doses of ZyCoV-D are to be administered on day 0, day 28, and day 56. The company is also said to be working on a two-dose vaccine.

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 its vaccine will hit the markets by June 2021.

Once Zydus receives approval, ZyCoV-D would become the fifth anti-Covid vaccine authorised for use in India, after AstraZeneca and Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, Sputnik V that is being developed by Russia’s Gamaleya Institute and Moderna.

Source: https://www.tbsnews.net/coronavirus-chronicle/zydus-cadilas-3-dose-covid-19-vaccine-kids-may-take-more-time-approval-273598