Zydus Cadila seeks emergency use authorization for its Covid-19 vaccine ZyCoV-D in India
Zydus Cadila has applied for Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) to launch its DNA vaccine, ZyCoV-D, for 12 years and above. The company said that its vaccine has completed Phase III trials.
If DGCA approves, ZyCoV-D will join Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin and Russia’s Sputnik V vaccines to authorize for emergency use in India.
According to the company’s claim, ZyCoV-D showed safety and efficacy during late-stage trials. It involved more than 28,000 volunteers from across the country. It included 1,000 subjects in the age group of 12-18 years.
Zydus said the study was done during the peak of the second wave in India. It said the drug is effective against mutant strains, especially the delta variant which is prevalent in India. The company said it has also evaluated a two-dose regimen for the ZyCoV-D vaccine, using a dose of 3 mg per visit and found immunogenicity results comparable to the current three-dose regimen.
“The company has applied for an EUA at DCGI’s office for ZyCoV-D – its plasmid DNA vaccine against COVID-19,” Zydus Cadila said in a statement.
Dr. Sharvil Patel, Managing Director, Cadila Healthcare, said that when the vaccine is approved, not only adults but also adolescents in the age group of 12 to 18 years will be helped.
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