ZyCoV-D is a plasmid DNA intradermal vaccine that can be stored at 2-8ºC, with stability at 25ºC for at least three months
Zydus seeks DCGI authorisation for ZyCoV-D. (Credit: cromaconceptovisual from Pixabay.)
Zydus Cadila has filed an application with the Drug Controller General of India (DCGI) seeking Emergency Use Authorisation (EUA) for its three-dose Covid-19 vaccine, ZyCoV-D.
ZyCoV-D is a plasmid DNA vaccine that produces the spike protein of the SARS-CoV-2 virus and triggers an immune response to protect from Covid-19 disease.
The three-dose, intradermal vaccine is administered using The PharmaJet needle-free system, ensuring painless intradermal vaccine delivery.
It can be stored at 2-8ºC, with stability at 25ºC for at least three months, facilitating easy transportation and storage and preventing any vaccine wastage.
Zydus said that the plasmid DNA platform offers ease of manufacturing with minimal biosafety requirements (BSL-1) and its ZyCoV-D has no problems linked to vector-based immunity.
Cadila Healthcare managing director Sharvil Patel said: “This breakthrough marks a key milestone in scientific innovation and advancement in technology.
“As the first-ever plasmid DNA vaccine for human use, ZyCoV-D has proven its safety and efficacy profile in our fight against Covid-19. The vaccine when approved will help not only adults but also adolescents in the 12 to 18 years age group.
“This has been possible because of the collective support of the Government, the regulators, the volunteers who had faith in the process.”
The company has conducted a large-scale clinical trial of its Covid-19 vaccine in nearly 1,000 adolescents, aged between 12 and 18 years, in more than 50 centres across India.
It was the first study to evaluate any Covid-19 vaccine in this age group, said the company.
In the study, the vaccine was well-tolerated, showed safety tolerability similar to that observed in the adult population, with no severe cases or deaths due to Covid-19.
Zydus said that its ZyCoV-D vaccine had already shown superior immunogenicity, tolerability and safety profile in the previous Phase1/2 clinical trials.
In a separate development, Zydus has also evaluated a two-dose regimen of ZyCoV-D vaccine using a 3mg dose, which showed immunogenicity similar to the three-dose regimen.
National Biopharma Mission, BIRAC, Department of Biotechnology, Govt of India, National Institute of Virology, Indian Council of Medical Research and PharmaJet supported the development of ZyCoV-D vaccine.