India’s indigenous, and the world’s first, DNA based COVID-19 vaccine has received Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI).

The vaccine named ZyCoV-D, developed by Zydus Cadila, can be administered to children and adults aged 12 years and above. The vaccine has been developed in association with the Department of Biotechnology (DB), and the Indian government under Mission COVID Suraksha and has been implemented by BIRAC. The Zydus Cadila vaccine received support for preclinical studies and Phase I and II clinical trials under the COVID-19 research consortia through National Biopharma Mission and for phase III clinical trial under Mission COVID Suraksha.

This three-dose vaccine produces the spike protein of the SARS-CoV-2 virus and evokes an immune response, contributing to protection from the disease and viral clearance. The plasmid DNA platform is based on the plug-and-play technology, which can be modified to tackle mutations in the virus.

Interim results from phase-III clinical trials, conducted in more than 28,000 participants, revealed that the vaccine has a primary efficacy of 66.6% for symptomatic RT-PCR positive cases. The vaccine had shown strong immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials conducted earlier. 

Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, “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 DBT and supported through Mission COVID Suraksha…”

Dr Renu stated that the aim of the Indian Vaccine Mission COVID Suraksha is to develop safe and efficacious COVID-19 vaccines. Dr Renu further stated that this vaccine is going to be an important vaccine for both India and the world. 

Pankaj R Patel, Chairman, Zydus Group, was happy that their efforts to bring out a safe, well tolerated and efficacious vaccine became a reality with ZyCoV-D. 

Source: ET Healthworld