Zydus Cadila has applied for Emergency Use Authorisation (EUA) nod from the Drugs Controller General of India (DCGI) for the launch of its DNA vaccine, ZyCoV-D, for 12 years and above. The company said that its vaccine has completed the third phase of trial.
If DGCA grants approval, ZyCoV-D will join Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin and Russia’s Sputnik V vaccines to be authorized for emergency use in India.
According to the company’s claim, ZyCoV-D showed safety and efficacy during a late-stage trial . It involved more than 28,000 volunteers across the country. This included 1,000 subjects in the 12-18 year age group.
Zydus said that the study was carried out during the peak of second wave in India. It said that the drug is effective against the mutant strains especially the Delta variant which is prevalent in India. The company said it has also evaluated a two dose regimen for ZyCoV-D vaccine using a 3 mg dose per visit and the immunogenicity results had been found to be equivalent to the current three dose regimen.
“The company has applied for EUA to the office of DCGI for ZyCoV-D – its Plasmid DNA vaccine against COVID-19,” Zydus Cadila said in a statement.
Dr. Sharvil Patel, Managing Director, Cadila Healthcare, said the vaccine when approved will help not only adults but also adolescents in the 12 to 18 years age group.