DCGI grants EUA to ZycovD COVID vaccine for two-dose regimen for children above 12
Apr 26, 2022
By Shalini Bhardwaj
Ahmedabad (Gujarat) [India], 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 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 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."
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.
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.
