The Indian drug regulator?s subject expert committee has recommended emergency use approval for Zydus Cadila?s three-dose COVID-19 vaccine.
The committee added that Zydus needs to submit additional data for the 2-dose regimen of its vaccine.
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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. It also said the vaccine is safe for children between 12 and 18 years of age. However, its trial data is not peer-reviewed yet.
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If approved, the vaccine will be India’s second indigenous vaccine and the fifth vaccine to be authorised for use in the country. India has already approved vaccines from Moderna, AstraZeneca and partner Serum Institute of India, Bharat Biotech, and Russia’s Gamaleya Institute.
Zydus Cadila had earlier said that they can launch the vaccine within two months of receiving the approval. The pharmaceutical firm had applied for an emergency use authorisation for the three-dose DNA vaccine on July 1.
ZyCov-D, which is being developed in partnership with the Department of Biotechnology and the Indian Council of Medical Research, can be stored at 2-8 degrees Celsius and at 25 degrees Celsius for up to three months. Once approved, it will be an intra-dermal (between skin and muscles) vaccine administered through a specialised needle-free injector. The currently licensed coronavirus vaccines are administered intra-muscularly.
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