On 20 August 2021,  the Drug Controller General of India  granted emergency use authorization (EUA) to ZyCoV-D (World’s 1st SARS-CoV-2 DNA-based vaccine) for use in humans, including children and adults twelve years and older. With the aim for effective, safe, and well-tolerated coronavirus vaccines for public health, it was made in partnership with Department of Biotechnology under ‘COVID Suraksha’ and enforced by Biotechnology Industry Research Assistance Council (BIRAC).

This indigenously developed three-dose vaccine has been favored under COVID-19 Research Consortia through National Biopharma Mission for the preclinical studies, phase 1 and phase 2 trials and under the mission COVID Suraksha for phase 3 trial. Injection of this vaccine generates the spike protein of the COVID-19 virus and triggers an immune response. This plays a pivotal role in the elimination of SARS-CoV-2 and defence from the disease. The plasmid DNA platform is based on plug-and-play technology and can be readily adapted for dealing with the mutations already occurring in the virus.

The interim findings from phase-3 trials in about 28,000 volunteers illustrated a primary efficacy of 66.6% for symptomatic RT-PCR positive cases. So far, this has been the largest clinical trial for the coronavirus vaccine in India. ZyCoV-D had already shown strong immunogenicity, safety and tolerability in the adaptive phase 1/2 trials conducted previously. The Data Safety Monitoring Board has monitored both phase 1/2 and phase 3 trials. In this success story, the vaccine research centre has also played an essential role. It is indeed a crucial achievement and positions India on the global map for production of novel vaccines in the fight against COVID-19 pandemic.