New Delhi: The Drugs Controller General of India (DCGI) is likely to give emergency use approval to Zydus Cadila for its COVID-19 vaccine for children above 12 years. According to reports, the ZyCov-D is likely to receive an emergency nod from DCGI in the next few days.
ZyCov-D vaccine has been tested on adults as well as children above 12 years of age and the regulatory body experts are satisfied with the results, the officials said.
“The preliminary assessment of the application submitted by the company is going on and we have sent it to the SEC for further consideration. The SEC will be meeting in the coming week, representatives of the company will be also asked to make presentations,” an official said.
Earlier, the head of the National Expert Group on Vaccine Administration, Dr NK Arora on July 9, 2021 had said that the vaccination for children will start by September with the Zydus vaccine for 12 to 18-year-olds. Dr NK Arora had also added that the emergency use authorisation for the vaccine is likely to come within weeks.
Dr NK Arora in an interview had said, “Covaxin phase 3 trials have started and by the end of September, I think we should be there (begin vaccination). I think sometime in the third quarter or by early January-February we should be able to give it to 2 to 18-year-olds. But trial data for Zydus Cadila for 12 to 18-year-olds will be available even before that.”
Zydus Cadila’s COVID-19 vaccine, ZyCov-D, is a three-dose, intradermal vaccine which is applied using the PharmaJet needle-free system. ZyCoV-D exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier. Both the Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board, the experts had said