India’s drug regulator DGCI has approved Gujarat-based Zydus Cadila’s three-dose COVID-19 vaccine for emergency use authorisation for in adults and children aged 12 years and above, bringing in the sixth vaccine authorised for use in the country.
Zydus Cadila’s vaccine, developed in partnership with the Department of Biotechnology, is the second home-grown shot to get emergency authorisation in India after Bharat Biotech’s Covaxin.
With the central drug regulator clearing the vaccine, Zydus Cadila’s ZyCoV-D is set to become the first Covid vaccine candidate developed on a plasmid DNA platform to be commercially introduced anywhere in the world.
The vaccine has been tested on 1,000 children above the age of 12 and had demonstrated a primary efficacy of 66.66 per cent in phase 3 clinical trials. It was the first Covid-19 vaccine in India to be tested in the adolescent population — those in the 12-18-year age group.
ZyCoV-D is the world’s first Covid-19 vaccine built on a DNA platform to be granted emergency use authorisation. Unlike mRNA vaccines, DNA-based vaccines do not require ultra-cold storage systems and are said to be more cost-effective.
So far, there are three vaccines that are being used in India’s immunisation drive — SII’s Covishield, Bharat Biotech’s Covaxin and Russia’s Sputnik V. Top government sources said the Zydus DNA COVID-19 vaccine is likely to arrive in the market by October.