The Central Drugs Standard Control Organisation's (CDSO) Subject Expert Committee (SEC) granted the EUA.

 

The Science and Technology Ministry statement said: "Zydus Cadila has received approval for Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D today."

 

ZyCoV-D is a first of its kind DNA vaccine that produces the spike protein of the SARS-CoV-2 to elicit an immune response. It is an intradermal vaccine that has to be applied using a 'needle-free injector', which, the manufacturer says, will help in reducing side effects.

 

Developed in partnership with the Department of Biotechnology, under 'Mission COVID Suraksha' and implemented by the BIRAC, ZyCoV-D has been supported under Covid-19 Research Consortia through National Biopharma Mission for Preclinical Studies, Phase 1 and Phase 2 Clinical Trials and under the Mission COVID Suraksha for Phase 3 Clinical Trial.

 

This 3-dose vaccine, 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.

 

The interim results from Phase 3 Clinical Trials, involving over 28,000 volunteers, showed primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases. This has been the largest trial so far in India for Covid-19 vaccines.

 

The vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase 1/2 clinical trials carried out earlier. The Phase 1/2 and Phase 3 clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB).