Thursday, 28 October 2021

The zyCov-D vaccine gets approval in India for emergency use

The zyCov-D vaccine gets approval in India for emergency use

The Indian drug regulator committee expert has also recommended approving Zydus Cadila's three-dose COVID-19 vaccine -ZyCoV-D- for emergency use authorization (EUA), Reuters reported citing CNBC-TV18.

The committee added that Zydus needs to submit additional data for the 2-dose regimen of its vaccine, CNBC-TV18 said

The generic drugmaker, listed as Cadila Healthcare Ltd, applied for the authorization of the vaccine ZyCoV-D on 1 July, based on an efficacy rate of 66.6% in a late-stage trial of more than 28,000 volunteers nationwide.

ZyCoV-D will become the fifth corona vaccine cleared for use in the country after locally produced Covishield, US-made Moderna, Russia's Sputnik V, and Bharat Biotech's Covaxin. Moreover, it will become the world's first DNA vaccine to get a nod in any country.

The Ahmedabad-based pharmaceutical company applied on 1 July for emergency use approval of the three-dose Covid-19 vaccine ZyCoV-D.

The company also submitted a figure estimate of a two-dose procedure of the shot. The SEC is likely to compare the data and make a decision on its go-ahead.

The zyCov D vaccine gets approval in India for emergency use 1getty image

Read More: Johnson & Johnson single dose Covid vaccine approved in India

The company has run the largest clinical trial for the COVID-19 vaccine in India in over 50 centers. The first time any COVID-19 vaccine was a trial in the adolescent population in India's 12-18 years age group. Around 1000 subjects were enrolling in the age group, and a vaccine was safe and very well tolerated. The excellent profile was similar to that seen in the adult population. Primary efficacy of 66.6% has been achieving for symptomatic RT-PCR positive cases in the interim analysis. At the same time, no moderate case of COVID-19 disease
was detected in the vaccine arm post command of the third dose, suggesting 100% efficacy for mild disease.

ZyCoV-D vaccine

ZyCoV-D is a plasmid DNA vaccine that produces the spike protein of the SARS-CoV-2. It 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.

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