The Zydus-Cadila ZyCoV-D Covid-19 vaccine has received Emergency Use Authorization (EUA) from the Drug Comptroller General of India (DCGI) on the 20th of August. It is the world’s first DNA based Covid-19 vaccine and it has been developed indigenously in India. The Zydus-Cadila vaccine can be administered in children as well and is applicable for use for ages 12 years and above.
The Government said in a press release, “Developed in partnership with the Department of Biotechnology, Government of India 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. This 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.”
It added, “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. 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 Government said that the 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 the development of the vaccine.
“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. The Indian Vaccine Mission COVID Suraksha was launched under the Atma Nirbhar Bharat package 3.0 being implemented by BIRAC, is aimed at the development of safe and efficacious COVID-19 vaccines for public health. 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,” said Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC.
Chairman of the Zydus Group, Pankaj R. Patel. stated, “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.”
The ZyCoV-D is the second indigenously developed vaccine to have received the DCGI approval. It has become the sixth vaccine to have received the approval. Earlier in August, Johnson & Johnson’s single dose vaccine was granted approval.
The other vaccines already approved in India are Covishield developed by Astra Zeneca and Oxford University, Covaxin developed by Bharat Biotech, Sputnik V developed in Russia and the vaccine developed by Moderna in the USA.