New Delhi: In a major breakthrough, Zydus Cadila on Friday received approval for Emergency Use Authorization from Drugs Controller General of India (DCGI) for ZyCoV-D, world’s first and India’s indigenously developed DNA based vaccine for Coronavrius.
Making the announcement, Ministry of Science & Technology said ZyCoV-D vaccine can be administered in humans including children and adults 12 years and above.
The DCGI nod came hours after an expert panel of India's central drug authority recommended granting emergency use authorisation to Zydus Cadila's three-dose COVID-19 vaccine.
The Ahmedabad-based pharma major had on July 1 applied for emergency use authorisation (EUA) with the DCGI for the vaccine. The company said it has conducted the largest clinical trial for the vaccine in India in over 50 centres so far.
With DCGI approval, ZyCov-D became the sixth vaccine that has been approved for use in the country after Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V and the US-made Moderna and Johnson and Johnson.
Plasmid DNA-based ZyCoV-D is to be administered intradermally using a needle-free injector.
According to the company, the vaccine will not only protect adults against Coronavirus, but can also be administered to adolescents in the 12 to 18 years age group.
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Zydus Cadila had presented interim results from Phase-III clinical trials in over 28,000 volunteers. The study is said to have demonstrated safety and efficacy in the interim data.
The data has shown that ZyCoV-D is safe for children in the age group of 12 to 18 years. The pharma major is planning to manufacture 100-120 million doses of the vaccine annually.