ZyCoV-D, a three-dose Covid-19 vaccine developed by Cadila Healthcare (Zydus Cadila), got Emergency Use Authorisation from the Drug Controller General of India (DCGI) on Friday and will be administered to persons aged 12 and above.
On Friday, India’s Drug Controller General granted emergency permission to the ZyCoV-D, a COVID-19 vaccine developed by Zydus Cadilla company, making it the first vaccination in India that may be administered to adults as well as children aged 12 and above. It’s also the world’s only DNA-based vaccine that can be administered without a needle, reducing the possibility of adverse effects.
In July, interim data from Phase-III Clinical Trials in over 28,000 volunteers revealed a primary efficacy of 66.6 percent 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 Department of Biotechnology said in a statement on Friday.
The vaccine was developed in collaboration with the Department of Biotechnology as part of the ‘Mission COVID Suraksha.’ Once given, the three-dose vaccine produces the spike protein of the SARS-CoV-2 virus and stimulates an immune response.
“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 DBT noted.
In prior remarks, the firm stated that it plans to produce 100-120 million doses every year, with a goal of producing half a million by the end of the year.
“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,” Pankaj Patel, Chairman, Zydus Group said in a statement.
This is the 5th vaccine to be licenced for use in India, following Covishield, Covaxin, Sputnik V, and Moderna. Despite approximately 570 million doses provided since January, Covishield and Covaxin remain the mainstays of India’s immunisation programme, with the former accounting for roughly 90 percent of doses administered so far. A third of individuals have received at least one dose, and 10 percent have received two doses.