Zydus Cadila’s Covid-19 vaccine developed for children above 12 years is likely to get emergency use approval from drug regulator Drugs Controller General of India (DCGI) in the next few days, sources have said. The vaccine has been tested on adults as well as children above 12 years of age and if the regulatory committee is satisfied with the data, it may be given approval for emergency use, officials said.
The regulator’s subject expert committee (SEC) will examine data submitted by Cadila. Officials said that if the approval is given, supply of the vaccine is expected to start by August-September. “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 Times of India.
Earlier Dr NK Arora, Chairperson of the Covid-19 Working Group of the National Technical Advisory Group on Immunization (NTAGI), reportedly said that the Zydus Cadila’s vaccine for the age group of 12-18 years is expected to be available by September end. In an interview to NDTV, Dr Arora had said that Zydus Cadila’s data for 12-18 year-olds will be available by next month or early September and that we will certainly be able to give it.
In an interview to Moneycontrol, Dr Sharvil Patel, Managing Director of Zydus Group said the company will start supplying the vaccine on receiving approvals from the regulators. “We will manufacture one crore doses per month initially and will ramp the production in the coming months,” he said.
If the vaccine gets nod, ZyCov-D would be the fifth vaccine against Coronavirus to get Emergency Use Authorisation in India.
ZyCov-D is a three-dose, intradermal vaccine which is applied using the PharmaJet needle-free system, the report added. It can be stored at 2-8 degree Celsius but has shown good stability at temperatures of 25 degree Celsius for at least 3 months. Apart from Cadila, Bharat Biotech is also testing Covaxin on children.