DCGI approves Cadila Healthcare's ZyCoV-D COVID vaccine for all above 12 years of age
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Cadila Healthcare (Zydus Cadila) received Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D, the world's first and India's indigenously developed DNA-based vaccine for COVID-19 to be administered in humans including children above 12 years of age and adults.
The vaccine has to be administered in three doses – the first dose, and the remaining doses after 28 and 56 days.
"This three-dose vaccine which when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from disease as well as viral clearance. The plug-and-play technology on which the plasmid DNA platform is based can be easily adapted to deal with mutations in the virus, such as those already occurring," said a release from the Ministry of Science and Technology.
Interim results from Phase-III Clinical Trials, in over 28,000 volunteers, showed primary efficacy of 66.6 percent for symptomatic RT-PCR positive cases. This has been the largest vaccine trial so far in India for COVID-19.
The vaccine was developed in partnership with the Department of Biotechnology, under the 'Mission COVID Suraksha' and implemented by BIRAC. ZyCoV-D has been supported under COVID-19 Research Consortia through National Biopharma Mission for Preclinical studies, Phase I and Phase II Clinical Trials and under the Mission COVID Suraksha for Phase III Clinical Trial.
