All you need to know about ZyCoV-D, India's 1st COVID vaccine for children above 12 years

In a breaking development, on August 20, the Drugs Controller General of India (DCGI) approved the Zydus Cadila COVID vaccine for children aged above 12 as ZyCoV-D for Emergency Use Authorisation (EUA). It becomes the world’s first and India’s indigenously developed DNA-based vaccine administered in humans including children and adults aged 12 years and above.

‘Mission COVID Suraksha’ 

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.

Clinical trials results

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).

Dr Renu Swarup, Secretary, DBT 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. 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”

The Indian Vaccine Mission COVID Suraksha was launched under the Atma Nirbhar Bharat package 3.0 being implemented by Biotechnology Industry Research Assistance Council (BIRAC), is aimed at the development of safe and efficacious COVID-19 vaccines for public health. 

About DBT

The Department of Biotechnology (DBT), under the Ministry of Science and Technology, promotes and improves biotechnology development in India through its development and implementation in agriculture, healthcare, animal sciences, the environment, and industry.

About BIRAC

A not-for-profit Public Sector Enterprise, Biotechnology Industry Research Assistance Council (BIRAC) has been set up by the Department of Biotechnology (DBT), Government of India, which acts as an interface agency to enhance and encourage the evolving biotechnology industry to implement strategic research and development activities in regards to the product development needs of the nation.