Emergency approval for Zydus Cadila's Covid-19 vaccine may take a few more days with the Ahmedabad-based pharma company set to submit additional data related to immunogenicity and safety of its Zycov-D vaccine to the Drugs Controller General of India (DCGI) this week, according to sources.
The drug regulator had asked Zydus Cadila to come back with more data on its Zycov-D, the sources informed ANI.
The regulator's SEC will examine the additional data that will be submitted by the pharma company this week. If the data is found to be satisfactory, then the final approval from DCGI may be granted in August, sources added.
Previously, the sources had toldthat a continuous and rolling review of data was being undertaken and final approval would take a few more days.
The Ahmedabad-based pharma firm had on July 1, requested emergency use approval for ZyCoV-D, its three-dose COVID shot - the world's first Plasmid DNA vaccine. If approved it will be the country's second indigenous vaccine after Bharat Biotech's Covaxin.
Earlier, the Delhi High Court said that if COVID-19 vaccines are administered to children without proper research then it may be a disaster while objecting to the submission of the petitioner seeking research on vaccines for children in a time-bound manner.
A division bench of Chief Justice D N Patel and Justice Jyoti Singh said, "It would be a disaster if vaccines are administered on children without proper research."
The Centre in an affidavit told the Delhi High Court that pharmaceutical major Zydus Cadila's COVID-19 vaccine may be available in the near future for children in the age group of 12 to 18 years.
Zydus Cadila has concluded its trial for children between the age group of 12 to 18 and is subject to statutory permissions, the Centre added.
( With inputs from ANI )
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