Indian pharmaceutical firm Zydus Cadila has sought the drug regulator’s nod for rolling out its COVID-19 vaccine for those of the age of 12 and above, reported news agency ANI. The company has applied the Emergency Use Authorisation (EUA) seeking approval from the Drugs Controller General of India‘s (DCGI) for ZyCoV-D – its Plasmid DNA vaccine against COVID-19.

Also read: Zydus Cadila requests human trial approval from DGCI for antibody cocktail

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.  

The vaccine has completed the third phase of the trial. In a first, Zydus Cadila tested its vaccine in the adolescent population in the 12-18 years age group. Around 1,000 subjects were involved in the test that was conducted at 50 centres in India, the company said in statement, as per media reports.

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. 

“No moderate case of COVID-19 disease was observed in the vaccine arm post administration of the third dose suggesting 100% efficacy for moderate disease,” Zydus Cadila’s statement read. There were no cases of extreme COVID-19 or deaths in the vaccine arm post the administration of the second vaccine dose. 

Also read: India gets 4th COVID vaccine. Know all about Moderna’s jab

Meanwhile, the company has also tested a two-dose regimen of its vaccine using a 3 mg dose per visit. Its immunogenicity 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.