India approves Zydus' DNA-based three-dose Covid vaccine for emergency use

Adolescents in the age group of 12-18 years can take the shot in India

Indigenously developed Zydus Cadila Covid vaccine ZyCoV-D has received approval for Emergency Use Authorisation from the Drug Controller General of India and it will be administered to people 12 years and above, the Department of Biotechnology said on Friday.

This is the world's first DNA-based vaccine against the coronavirus, and this three-dose vaccine 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 the disease as well as viral clearance, it said.

The government's Department of Biotechnology (DBT) also said that 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.
 

"Zydus Cadila has received approval for Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D today i.e. 20/08/2021, the world's first and India's indigenously developed DNA-based vaccine for COVID-19 to be administered in humans including children and adults 12 years and above," it said.

The vaccine has been developed in partnership with the DBT under Mission COVID Suraksha, the department said.

"It has been implemented by the BIRAC (Biotechnology Industry Research Assistance Council) and ZyCoV-D has been supported under the 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,” the DBT said.

The company said it plans to manufacture 100 million to 120 million doses of ZyCoV-D annually and has started to stockpile the vaccine. The company also plans to seek approval for two-dose regimen of vaccine.

The generic drugmaker, listed as Cadila Healthcare Ltd, applied for the authorization of ZyCoV-D on July 1, based on an efficacy rate of 66.6% in a late-stage trial of over 28,000 volunteers nationwide.

The drugmaker said in July its COVID-19 vaccine was effective against the new coronavirus mutants, especially the Delta variant, and that the shot is administered using a needle-free applicator as opposed to traditional syringes.

Speaking on the development, Chairman of the Zydus Group, Pankaj R. Patel said: “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. I’d like to thank the Department of Biotechnology, Government of India for their support in this mission of Atma Nirbhar Bharat and Indian Vaccine Mission COVID Suraksha.”