A vaccine against the coronavirus disease (Covid-19) for children being developed by Gujarat-based drug 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.
Zyvox-D is a three-dose vaccine
- During the peak of the second wave of COVID-19 (in India), the study was conducted confirming the vaccine’s efficacy against new mutant strains, especially the delta variant,” Zydus Cadila 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 Cadila receives approval, ZyCoV-D would become the fifth anti-Covid vaccine authorized 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.
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