September 30, 2022

DCGI grants EUA to ZycovD COVID-19 vaccine for two-dose regimen for children above 12

NEW DELHI: Zydus Lifesciences Ltd., a discovery driven global lifesciences company announced that its novel COVID-19 vaccine, ZyCoV-D has received Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) as a two dose vaccine.

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 for the vaccine and reduce the overall time required for vaccination to improve immunity against the virus. It will also help in administering the vaccine in 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 3100 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 the
Phase I/II clinical trial (three dose regimen) has also been published in the EClinical Medicine Journal of The Lancet.

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