Zydus Cadila's COVID-19 vaccine nod a global first in plasmid DNA jabs

With the Emergency Use Authorisation (EUA) approval for Zydus Cadila's ZyCoV-D, India now not only has got its first coronavirus vaccine for the adolescents in the 12-18 age group, but also the world's first plasmid DNA vaccine for COVID-19.

This will be a three-dose vaccine that will be administered first on day zero, day 28th and then on the 56th day. The vaccine will be administered needle-free using 'PharmaJet', a needle-free applicator, which ensures painless intradermal vaccine delivery.

The company plans to manufacture 10-12 crore doses of ZyCoV-D annually.

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Zydus Cadila says 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. 

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. 

When administered, it 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.

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"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," said Pankaj R. Patel, Chairman, Cadila Healthcare.

Zydus acknowledges the support of 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.

Facts about the vaccine 

• ZyCoV-D is an intradermal vaccine, which will be administered in three doses.
• It will be applied using The PharmaJet needle-free system, Tropis, which can also lead to a significant reduction in any kind of side effects.
• ZyCoV-D is stored at 2-8 degrees Celsius but has shown good stability at temperatures of 25 degrees Celsius for at least three months. The thermostability of the vaccine will help in easy transportation and storage of the vaccine and reduce any cold chain breakdown challenges leading to vaccine wastage.
• The plasmid DNA platform provides ease of manufacturing with minimal biosafety requirements (BSL-1).
• Also being a Plasmid DNA vaccine, ZyCoV-D doesn't have any problem associated with vector-based immunity.
• The Plasmid DNA platform also allows generating new constructs quickly to deal with mutations in the virus, such as those already occurring.
• The results of the Phase I part of the Phase I/II clinical trial have already been published in the EClinical Medicine Journal of Lancet.