Ahmedabad, April 26: The Drugs Controller General of India (DCGI) on Tuesday granted Emergency Use Authorisation (EUA) to Zydus Cadila vaccine (ZycovD) for Covid-19 as a two-dose vaccine for children above the age of 12 years, said Zydus Lifesciences Ltd, the pharmaceutical company.
With this approval, the Covid-19 vaccine will now be administered on Day 0 and Day 28. Earlier, the vaccine was approved in a three-dose regimen to be administered on Day 0, Day 28 and Day 56.
Speaking on the development, Dr Sharvil Patel, Managing Director, Zydus Lifesciences said, "The approval of a two-dose regimen for ZyCoV-D is a welcome development. This will increase the compliance with the Covid-19 vaccine and reduce the overall time required for vaccination to improve immunity against the virus. It will also help in administering the vaccine to a larger population in a shorter time which is always desirable in the midst of a pandemic."
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The two-dose regimen for ZyCoV-D was tested in 3,100 healthy volunteers more than 12 years of age. Earlier, the safety and efficacy analysis data from Phase III clinical trial of its Plasmid DNA Covid-19 vaccine ZyCoV-D (three-dose regimen) has been peer-reviewed and published in The Lancet, a reputed and well known medical journal. The results of the Phase I part of Phase I/II clinical trial (three-dose regimens) have also been published in the EClinical Medicine Journal of The Lancet.
Also read | DCGI grants EUA to Corbevax for those aged 5-12, Covaxin for 6-12 age group
Earlier, the DCGI gave restricted emergency use authorisation to Covaxin for the 6-12 age group. The Corbevax is currently being administered to children in the age group of 12-14. Covid-19 vaccinations for minors in India were started from January 3 onwards for those in the 15-18 age group with Bharat Biotech's Covaxin.
The drive later expanded on March 16 to include children aged above 12 for Corbevax.
Overall India is currently administering two COVID-19 vaccines for children above 12.
-PTC News
