Zydus Cadila has received approval for Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D on Friday.
This is the world’s first and India’s indigenously developed DNA based vaccine for Covid-19 to be administered in humans including Children and adults 12 years and above.
The Central Drugs Standard Control Organisation, in its official Twitter account, said that after evaluation of interim phase III clinical trial results in consultation with Subject Expert Committee, CDSCO has approved DNA Covid-19 vaccine (ZyCoV-D) of Cadila Healthcare for restricted use in emergency situation in India for 12 years and above.
"The vaccine has efficacy of 66.6% and it is to be stored at 2°C to 8°C. The vaccine is needle free to be administered intradermally in three doses at day 0, 28 and 56," it added.
Developed in partnership with the Department of Biotechnology, Government of India under the ‘Mission Covid Suraksha’ and implemented by Biotechnology Industry Research Assistance Council (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.
The 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.
Interim results from phase-III clinical trials, in over 28,000 volunteers, showed primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases. This has been the largest vaccine trial so far in India for Covid-19. The 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).
Vaccine Technology Centre (VTC), vaccine research centre of the Zydus group, Translational Health Science and Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology (DBT and Interactive Research School for Health Affairs (IRSHA), Pune, GCLP Lab set up under the Department of Biotechnology - National Biopharma Mission (NBM) also played a vital role in developing the vaccine.
Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said that “It is a matter of great pride that today we have the EUA for the world’s first DNA Covid-19 vaccine ZyCoV-D by Zydus developed in partnership with the Department of Biotechnology and supported through Mission Covid Suraksha."
"This is an important milestone in our Indigenous Vaccine Development Mission and positions India on the Global Map for Novel Vaccine Development," she said.
Pankaj R Patel, chairman of the Zydus Group, said, “We are extremely happy that our efforts to put out a safe, well tolerated and efficacious vaccine to fight Covid-19 has become a reality with ZyCoV-D".
The Government has recently approved emergency use of Johnson & Johnson's single-dose vaccine for Covid-19, as the fifth vaccine under the Emergency Use Authorisation (EUA) to fight the pandemic that has been affecting the normal life of over 130 crore Indians for over 18 months, now.