Zydus Cadila said that it got Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) for its ZyCoV-D coronavirus vaccine on Friday. ZyCoV-D is the world’s first and India’s indigenously developed DNA-based vaccine for COVID-19 that can be administered for children above 12 years of age and adults.
The Drugs Controller General of India’s (DCGI’s) gave its green signal for the second indigenously developed vaccine and it will also help India speed up its immunization effort to stop the spread of dangerous coronavirus.
An expert panel recommended that Zydus Cadila's three-dose covid-19 vaccine has got approval for emergency use, clearing the way for formal approval by the DCGI.
"This three-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," said a release from the Ministry of Science and Technology.
"In previous adaptive Phase I/II clinical trials, this vaccine has demonstrated a strong immunogenicity, tolerance, and safety profile. An independent Data Safety Monitoring Board (DSMB) oversaw both the Phase I/II and Phase III clinical trials " the press release said.
The vaccine was developed in collaboration with the Department of Biotechnology and implemented by BIRAC as part of the "Mission COVID Suraksha". ZyCoV-D has received funding from the COVID-19 Research Consortia, the National Biopharma Mission, and the COVID Suraksha Mission for preclinical studies, Phase I and Phase II clinical trials, as well as the COVID Suraksha Mission for Phase III clinical trials.
"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, and 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," Renu Swarup, Secretary, DBT and Chairperson, BIRAC, said.