Zydus vaccine gets DCGI nod for emergency use, to be given to people aged 12 years and above
Indigenously developed Zydus Cadila COVID-19 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.
With Emergency Use Authorisation (EUA), ZyCoV-D has also become the first vaccine to be administered to those in the age group of 12-18 years in the country.
Vaccines Covishield, Covaxin and Sputnik V are being given to only those above 18 years of age and unlike ZyCoV-D, which is three-dose, these are administered in two doses.
The Department of Biotechnology (DBT) said that ZyCoV-D is the world's first DNA-based vaccine against the coronavirus and 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.
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, it said.
"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," the government department said.
ZyCoV-D is a needle-free vaccine administered using PharmaJet', an applicator that ensures painless intradermal vaccine delivery, Zydus Cadila has said.
The DBT said that Interim results from Phase-III clinical trials in over 28,000 volunteers, showed primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases.
This has been the largest vaccine trial so far in India for COVID-19, it said.
The vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier. Both Phase I/II and Phase III clinical trials have been monitored by an independent data safety monitoring board, the DBT added.
Till now, there were five EUA-granted vaccines -- Serum Institute of India's Covishield, Bharat Biotech's Covaxin, Russian vaccine Sputnik V, the vaccines of Moderna, and Johnson and Johnson.
Of these, Covishield, Covaxin and Sputnik V are in use in the country. ZyCoV-D will be the sixth to be added to the vaccine basket of the country.
In a Union health ministry briefing on May 13, Member (Health), Niti Aayog, V K Paul, had estimated that there would be 216 crore vaccines doses available for people in the country between August to December.
Of these, Zydus Cadila will provide five crore doses, he had said.
Zydus Cadila in a statement said it plans to manufacture 10-12 crore doses of ZyCoV-D annually.
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, a PSU of the DBT) 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.
Vaccine Technology Centre, the vaccine research centre of the Zydus group, Translational Health Science and Technology Institute, an autonomous body of the DBT and Interactive Research School for Health Affairs, Pune, GCLP Lab set up under the National Biopharma Mission (NBM) also played a vital role in this, the department added.
DBT Secretary and BIRAC Chairperson Renu Swarup said the development is an important milestone in the country's indigenous vaccine development mission and positions India on the global map for novel vaccine development.
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 official said.
We are confident that this will be an important vaccine for both India and the world, Swarup said.
Speaking on the development, chairman Zydus Group Pankaj 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, Patel added.