Zydus Cadila's ZyCoV-D vaccine gets DCGI authorisation for emergency use
20 August 2021
Zydus Cadila has received emergency use authorisation (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D, the world’s first and indigenously developed DNA-based vaccine against the Wuhan virus, including children and adults 12 years and above.
Developed in partnership with the the Department of Biotechnology, and implemented by BIRAC, ZyCoV-D is a 3 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.
The interim results from Phase-III clinical trials of the vaccine, 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 the SARS-CoV-2. 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).
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 this success story.
“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... We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our indigenous vaccine development mission and positions India on the global map for novel vaccine development,” Dr Renu Swarup, secretary, DBT and chairperson, BIRAC, said.
The Indian Vaccine Mission Covid Suraksha, launched under the Atma Nirbhar Bharat package 3.0 and being implemented by BIRAC, is aimed at the development of safe and efficacious SARS-CoV-2 vaccines for public health.
“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. To create the world’s first DNA vaccine at such a crucial juncture and despite all the challenges, is a tribute to the Indian research scientists and their spirit of innovation. I’d like to thank the Department of Biotechnology, Government of India for their support in this mission of Atma Nirbhar Bharat and Indian Vaccine Mission Covid Suraksha,” chairman of the Zydus Group, Pankaj R Patel, said.