Mon. Oct 18th, 2021
 
DCGI approves Cadila Healthcare's ZyCoV-D COVID vaccine for all above 12 years of age

DCGI approves Cadila Healthcare’s ZyCoV-D COVID vaccine for all above 12 years of age

Cadila Healthcare (Zydus Cadila) on August 20 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.

 

DCGI approves Cadila Healthcare’s ZyCoV-D COVID vaccine for all above 12 years of age

DCGI approves Cadila Healthcare's ZyCoV-D COVID vaccine for all above 12 years of age
DCGI approves Cadila Healthcare’s ZyCoV-D COVID vaccine for all above 12 years of age

 

 

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.

 

“This vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier. Both the Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB),” the release added.

 

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.

 

Vaccine Technology Centre (VTC) of the Zydus group, Translational Health Science and Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology (DBT), Interactive Research School for Health Affairs (IRSHA), Pune, and GCLP Lab set up under the Department of Biotechnology – National Biopharma Mission (NBM) also played a vital role in the development of the vaccine.

Subhangee Guha

Break the Newz.

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