Drugs Controller General of India (DCGI) will consider granting emergency use approval for Zydus Cadila's COVID-19 vaccine-ZyCov-D for children above 12. This vaccine has been tested on children above 12 as well as adults.
The Subject Expert Committee (SEC) will examine the data submitted by the pharma major. If the committee finds the phase-3 trial data and documents submitted by Cadila satisfactory, emergency use approval will be granted for the vaccine this week itself.
"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 The Times of India.
ZyCov-D has already shown strong immunogenicity and tolerability and safety profile in phase 1 and phase 2 trials. Once approved, the vaccine supply is likely to begin in August-September and ZyCov-D will be the fifth vaccine against coronavirus to get approved in India.
Zydus Cadila's jab is a three-dose, intradermal vaccine which is administered using the PharmaJet needle-free system. It does not need very low storage temperatures and can be stored at 2-8 degree Celsius. This, in turn, will lead to glitch-free transportation and storage and reduce any chances of vaccine wastage.
Edited by Mehak Agarwal