A coronavirus disease (Covid-19) vaccine 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 main drug regulator is expected. take a few more days.
On July 1, the company requested authorization for emergency use of ZyCoV-D, its DNA vaccine against Covid-19 for people aged 12 and over, from the Drugs Controller General of India (DCGI ). He had presented interim results from phase III clinical trials involving more than 28,000 volunteers. The study would have demonstrated safety and efficacy in interim data.
The data showed that ZyCoV-D is safe for children between the ages of 12 and 18, said the company, which plans to manufacture 100 to 120 million doses of the vaccine per year.
The study was carried out “during the peak of the second wave of Covid-19 (in India), reaffirming the effectiveness of the vaccine against new mutant strains in particular 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 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.