1 min read.Updated: 20 Aug 2021, 02:04 PM ISTLivemint
The Ahmedabad-based pharmaceutical firm had on 1 July applied for emergency use authorization of its ZyCoV-D three-dose Covid-19 vaccine
The Indian drug regulator's subject expert committee has 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 authorisation of the vaccine ZyCoV-D on July 1, based on an efficacy rate of 66.6% in a late-stage trial of more than 28,000 volunteers nationwide.
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
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.
The company conducted the largest clinical trial for its COVID-19 vaccine in India so far in over 50 centres. This was also the first time that any COVID-19 vaccine has been tested in the adolescent population in the 12-18 years age group in India. Around 1000 subjects were enrolled in this age group and the vaccine was found to be safe and very well tolerated. The tolerability profile was similar to that seen in the adult population. Primary efficacy of 66.6% 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% efficacy for moderate disease.
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 the 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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