INDIA. Mumbai: The Zydus Cadila on Friday announced that the company has received the Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D, the world’s first Plasmid DNA Vaccine for COVID-19.
ZyCoV-D is a three-dose vaccine that will be administered first on day zero, day 28th, and then on the 56th day. With this approval, India now has its first COVID-19 vaccine for adolescents in the 12-18 age group, besides the adult population. ZyCoV-D is a needle-free vaccine administered using The PharmaJet® a needle-free applicator, which ensures painless intradermal vaccine delivery, the Ahmedabad (Gujarat) based Cadila Healthcare Limited said in a statement.
This is for the first time that a technologically advanced vaccine has been successfully developed on the Plasmid DNA platform for human use. The platform because of its rapid plug-and-play technology can be easily adapted to deal with mutations in the virus, such as those already occurring. The company plans to manufacture 10-12 crore doses of ZyCoV-D annually.
Speaking on this development, Cadila Healthcare Ltd Chairman Pankaj R. Patel, said “This is a historic milestone with ZyCoV-D, a product of Indian innovation becoming the world’s first DNA vaccine being offered for human use and supporting the world’s largest immunization drive. We are particularly happy that our vaccine will contribute to this fight against COVID-19 and enable the country to vaccinate a larger population especially in the age group of 12-18 years”.
“ I would like to thank all the researchers, clinical trial investigators, volunteers, and the regulators who have supported this endeavour.” The company also plans to seek approval for the two-dose regimen of the vaccine. The main advantage of DNA vaccines is their ability to stimulate both the humoral and cellular arms of the adaptive immune system. They are a valuable form of antigen-specific immunotherapy, as they are safe, stable, and can be easily produced. Zydus acknowledges the support of the National Biopharma Mission, BIRAC, Department of Biotechnology, Govt of India, National Institute of Virology, Indian Council of Medical Research, and PharmaJet® in the development of ZyCoV-D vaccine”, Patel added.
The ZyCoV-D is a Plasmid DNA vaccine which when administered produces the spike protein of the SARS-CoV-2 virus and elicits an immune response mediated by the cellular and humoral arms of the human immune system, which play a vital role in protection from disease as well as viral clearance.
If approved, ZyCoV-D will be India’s second indigenous coronavirus vaccine after Covaxin, and the sixth vaccine to be approved in the country so far, joining the leagues of Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V, and the US-made Moderna and Johnson & Johnson’s “Janssen COVID-19 vaccine”(a single dose vaccine).
Two vaccine candidates have been tested among children in India: Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCov-D. The Covaxin trial includes 525 volunteers while ZyCov-D’s trials – as part of phase II/III clinical studies – include 1,000 volunteers in the 12-18 age group.
The SEC might also deliberate on the Russian-made single-dose vaccine, Sputnik V, called Sputnik Light. To expedite quality checks of Covid-19 vaccine batches, the Centre has approved the setting up of another lab National Institute of Animal Biotechnology in Hyderabad.