DCGI likely to approve Zydus Cadila's vaccine for children above 12 years

Zydus Cadila will soon receive an emergency go-ahead from the Drugs Controller General of India (DCGI) for its COVID-19 vaccine for children above twelve years. Zydus's ZyCov-D vaccine has been tested on both, adults and children above the age of twelve and according to the regulatory bodies, the experts are satisfied with it. 

“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 told a leading news channel. 

Recently, Dr NK Arora, the head of the National Expert Group on Vaccine Administration had said on July 9, 2021, that the process of vaccination for children will begin from September with the Zydus vaccine for 12 to 18-year-olds. 

About Zydus Cadila's COVID-19 vaccine

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 before.