Zydus Cadila was the second Indian company to receive an approval to start a vaccine trial in the country.
Amid warnings of a third wave of Covid-19 speculated to affect children the most, sources told CNN-News18 that Zydus Cadila is likely to submit an application for Emergency Authorisation Approval (EUA) within two weeks to the Drugs Controller General of India (DGCI).
If Zydus Cadila supplies five crore vaccines then it will be used for children, as well. After covering adults and 12-18 year old children in its ongoing clinical trials, Zydus Cadila plans to begin testing its COVID-19 vaccine, ZyCoV-D, with children aged 5 to 12.
Meanwhile, Covaxin trials on children will be completed in the next eight weeks.
The Brihanmumbai Municipal Corporation on Friday wrote to the Central government seeking permission to conduct trials of Bharat Biotech’s vaccine — Covaxin — on children of 12-18 ages. Speaking to CNN-News18, Additional Municipal Commissioner Suresh Kakani said, “We have conveyed our willingness to conduct trials in kids aged between 12-18. We are awaiting a nod from that agency, so that we can take it forward. We have to take permission of the ethics committee, once the nod is given.”
Zydus Cadila was the second Indian company to receive an approval to start a vaccine trial in the country.
Dubbed as ZyCoV-D, it will be first Made-in-India DNA vaccine candidate against coronavirus. The drugmaker will submit the trial results to the regulator by the end of this month. “We are still on track for May-end submission to the regulator once we see event data that we are expecting this month which will talk about the efficacy of the drug as the safety is already well-established,” Sharvil Patel, managing director (MD) of Zydus Group had told CNBC TV18 earlier.
“Then, we will file for an emergency use authorisation and post that we have to go through the formalities of approvals, testing, getting the plant audited, getting the Central Drugs Laboratory (CDL) testing done and then launch the product in the market,” Patel had said.
“We believe that by the end of this year we can make around five crore doses and looking to further scale it up, if possible, during the next six months,” he had further added.
India will have enough coronavirus vaccine doses to inoculate all citizens by December, VK Paul, the head of the national task force on COVID-19 vaccines, had said earlier. “Overall, 216 crore doses of vaccines will be manufactured in India between August and December, for India and for Indians. There should be no doubt that vaccines will be available for all as we move forward,” Paul had said.
