ZyCoV-D is a needle-free vaccine that will be administered in three doses.
The Drug Controller General of India has granted Emergency Use Authorisation (EAU) to Zydus Cadila’s COVID-19 vaccine, ZyCoV-D, which is touted to be world’s first Plasmid DNA vaccine against coronavirus. This will be administered to adolescents in the age group of 12 and 18 years, in addition to the adult population. The needle-free vaccine will be administered in three doses — on day zero, day 28th and then on the 56th day, the company said in a press statement on Friday, August 20. The needle-free vaccine will be administered using PharmaJet, a needle-free applicator, it said. When injected, the DNA-based vaccine will produce 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, said the government's Department of Biotechnology (DBT). 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 department said. Zydus Cadila plans to manufacture 10-12 crore doses of ZyCoV-D annually. The Ahmedabad-based pharmaceutical company also plans to seek approval for the two-dose regimen of the vaccine. 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 interim analysis of the vaccine showed a primary efficacy of 66.6%. The vaccine can be stored at 2-8ºC and even at temperatures of 25ºC for at least three months, the company had said. Zydus Cadila’s ZyCoV-D becomes the sixth vaccine to get the EUA in India. Serum Institute of India's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V, Moderna vaccine and Johnson and Johnson’s vaccine are the other COVID-19 vaccines in India. Zydus Cadila concluded its clinical trial for those in the age group of 12 to 18 years, the Union government had told the Supreme Court that last month. The company’s vaccine may be available to adolescents subject to statutory permissions.
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