Zydus likely to get approval for COVID vaccine for 12-15 age group this week

Indian pharma giant Zydus Cadila, which applied for emergency use of its COVID vaccine for children above 12 years on July 1, is likely to get the nod from India’s drug regulator Drugs Controller General of India (DCGI) this week, according to a report by The Times Of India.

Zydus has informed the regulator that the vaccine has been tested on adults as well as children above 12 years of age. The data will be examined by regulator’s subject expert committee (SEC) and officials said that if the approval is given, supply of the vaccine is expected to start by August-September. “The SEC will be meeting in the coming week, representatives of the company will be also asked to make presentations,” an official told TOI.

Also Read| Medical bodies, world leaders divided on COVID vaccine booster shots

If approved, this will be the world’s first DNA vaccine against coronavirus and the fifth to be available in India, after AstraZeneca’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V and USA’s Moderna.

DNA-Plasmid-based ZyCoV-D is a three-dose vaccine and is to be administered intradermally. It needs a storage temperature of 2-4°C, thus is easy to transport in India.   

Zydus has tested its vaccine on around 1,000 subjects in the age group of 12-18 and the trials were conducted at 50 centres in India, the company said in statement.

Also read: A Pfizer/Moderna booster after a J&J shot? Here is what experts say

In the trial, the vaccine was found to be “safe and very well tolerated.” “The tolerability profile was similar to that seen in the adult population,” the company said.

The shot showed primary efficacy of 66.6% in symptomatic RT-PCR positive cases in the interim analysis. 

Meanwhile, the company has also tested a two-dose regimen of its vaccine using a 3 mg dose per visit and it was found to be equivalent to the three-dose regimen. This means that the full course duration of vaccination might be reduced while maintaining the high safety profile of the vaccine.