Zydus-Cadila 3-dose COVID-19 vaccine gets EUA for children above 12 years

Zydus-Cadila three-dose COVID-19 vaccine has been given the green light for emergency use authorization for use in children above 12 years and adult. This is the first vaccine to be administered to the adolescent population in children. The ZyCoV-D is will also be the first COVID vaccine developed on a plasmid DNA platform to be commercially introduced anywhere in the world.

The Ahmedabad-based generic drug maker had applied for EUA for its vaccine ZyCoV-D on July 1, based on an efficacy rate of 66.6% in a late-stage conducted on more than 27,000 volunteers nationwide, in over 50 trial centres. It has also been tested on 1,000 children above the age of 12. Zydus-Cadila had earlier said that the two-dose regime works as well as the three-dose regime, and has submitted relevant data on this for further scrutiny. When the DNA plasmid is injected into the human cell, it enters the nucleus and reproduces spike proteins; in response the human body generates antibodies.

Unlike other COVID vaccines, ZyCoV-D is a first of its kind DNA vaccine that produces the spike protein of the SARS-CoV-2 to elicit an immune response. It is an intradermal vaccine that has to be applied using a “needle-free injection”, which the manufacturer says will help in reducing side effects. The vaccine, jointly developed in partnership with the Department of Biotechnology, had demonstrated a primary efficacy of 66.6% in phase 3 clinical trials. Moreover, it was the first COVID-19 vaccine in India to be tested in the adolescent population, those in the 12-18 year age group.

Government sources said the ZyCoV-D is likely to arrive in India in the market by October. In July, the pharma company had said it plans to manufacture 10-12 crore doses annually. Zydus-Cadila claims its technology is ideally suited for tackling COVID-19 as it can be easily adapted to deal with mutations in the virus, such as those already occurring.

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India is already using three vaccines – Covishield, Covaxin and Russian Sputnik V. It should be noted that Moderna’s mRNA vaccine and the single-dose vaccine developed by Johnson & Johnson have also received EUA, but they are not being used in the national vaccination drive.