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Zydus Cadila Vaccine Gets DCGI Nod for Emergency Use

Zydus Cadila Vaccine Gets DCGI Nod for Emergency Use

In a major breakthrough, Zydus Cadila 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.

ZyCoV-D is a three-dose, intradermal vaccine, which is applied using a needle-free system, Tropis, which can also lead to a significant reduction in any kind of side effects.

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.

The tolerability profile was similar to that seen in the adult population. Primary efficacy of 66.6 per cent has been attained for symptomatic RT-PCR positive cases in the interim analysis.

Whereas, no moderate case of Covid-19 disease was observed in the vaccine arm post administration of the third dose suggesting 100 per cent efficacy for moderate disease.

ZyCoV-D had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier. Both the Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB).

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.

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