A vaccine against the Covid-19 infection in children, being developed by Gujarat-based pharmaceutical company Zydus Cadila, may soon be available for children in the age group of 12 to 18, the central government told Delhi High Court on Friday.
“Zydus Cadila has concluded its trial for children between the age group of 12 to 18 and is subject to statutory permissions," the Centre said in an affidavit submitted in the court.
The Centre said that on May 12 the DCGI granted approval to Bharat Biotech to carry out clinical tests on volunteers, aged between 2 and 18, for Covaxin.
The pharmaceutical firm Zydus Cadila had on July 1 sought emergency use authorisation of its ZyCoV-D three-dose Covid-19 vaccine from the Drugs Controller General of India (DCGI). It submitted data evaluating a two-dose regimen for the shot. The data had results from Phase-III clinical trials in over 28,000 volunteers.
However, according to a recent report in ANI, a go ahead from the DCGI is likely to take a few more days.
If the approval is given, the ZyCoV-D will become the fifth vaccine cleared for use in the country after locally produced Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V and the US-made Moderna.
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), had 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.