Zydus Cadila's needle-free Covid-19 vaccine, ZyCoV-D, gets approval in India: Report
New Delhi : Zydus Cadila had applied for emergency use authorization of its needle-free ZyCoV-D three-dose Covid-19 vaccine on July 1.
The Indian drug regulator's has reportedly approved Zydus Cadila's three-dose COVID-19 vaccine -ZyCoV-D- for emergency use authorization (EUA), Reuters reported citing CNBC-TV18.
According to the report, the committee has asked Zydus to submit additional data for the 2-dose regimen of its vaccine.
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.
With this it could become India's the fifth vaccine for use 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 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.