Drugs Controller General of India (DCGI) on Friday approved Zydus Cadila's Covid vaccine ZyCoV-D for Emergency Use Authorisation (EUA).
Previously, India's central drug authority's expert panel sent recommendations for the vaccine's EUA to the Drugs Controller General of India (DCGI) for final approval.
Drugs Controller General of India (DCGI) on Friday approved Zydus Cadila's Covid vaccine ZyCoV-D for Emergency Use Authorisation (EUA).
Earlier on Friday, India's central drug authority's expert panel recommended granting Zydus Cadila's three-dose COVID-19 vaccine ZyCoV-D the Emergency Use Authorisation (EUA), sources said.
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 application given by Zydus Cadila on Thursday was deliberated by the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO). They also recommended granting emergency use authorisation to its three-dose coronavirus vaccine.
The Ahmedabad-based pharma major had on July 1 applied for emergency use authorisation (EUA) with the DCGI for the vaccine.
The company said it has conducted the largest clinical trial for the vaccine in India in over 50 centres so far.
If approved, ZyCoV-D will be the world's first DNA vaccine against the novel coronavirus infection, developed by an Indian company and become the sixth vaccine which has been approved for use in the country after Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V and the US-made Moderna and Johnson and Johnson.
Plasmid DNA-based ZyCoV-D is to be administered intradermally using a needle-free injector.
Sharvil Patel, managing director, Cadila Healthcare had said that the vaccine, when approved, would help not only adults but also adolescents in the 12 to 18 years age group.
(With PTI Inputs)