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Indian drug manufacturer Zydus Cadila is learnt to have submitted additional data related to immunogenicity and safety to India's drug regulator, reported news agency ANI quoting sources.

The Drug Controller General of India (DCGI) had earlier asked the Ahmedabad-based firm to return with more data on its Zycov-D.

The regulator's Subject Expert Committee (SEC) will examine the additional data and decide on granting the emergency use authorisation (EUA) based on it.

Previously, the ANI had reported that a continuous and rolling review of data was being undertaken and final approval would take a few more days.

Approval for Zydus Cadila

The Ahmedabad-based pharmaceutical firm had on 1 July applied for emergency use authorization of its ZyCoV-D three-dose Covid-19 vaccine.

The company also submitted data evaluating a two-dose regimen for the shot. The SEC is likely to compare the data and make a decision on its go-ahead.

If given approval, the ZyCoV-D would become the fifth vaccine cleared for use in the country after locally produced Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V and the US-made Moderna.

Also, it will become the world’s first DNA vaccine to get the nod in any country.

About the vaccine

ZyCoV-D is a plasmid DNA vaccine that produces the spike protein of the SARS-CoV-2 and elicits an immune response mediated by the cellular (T lymphocytes immunity) and humoral (antibody-mediated immunity) arms of the human immune system.

The vaccine has shown efficacy of 66.6% against symptomatic Covid cases and 100% for moderate disease.

It is an intradermal vaccine, applied using a ‘needle-free injector’. Zydus claims the needle-free system can lead to a significant reduction in side effects.

Zydus has claimed to have conducted the largest clinical trial for a Covid-19 vaccine in India in over 50 centres. This was also the first time that any Covid-19 vaccine had been tested in the 12-18-year age group in the country.

The vaccine is said to have shown safety and efficacy in a late-stage trial with more than 28,000 volunteers, including 1,000 subjects in the 12-18 year age group.

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