The Subject Expert Committee of the Indian Drug Regulator Authority has recommended approving Zydus Cadila’s three-dose COVID-19 vaccine -ZyCoV-D- for emergency use authorization (EUA). The SEC has sent recommendations to the Drugs Controller General of India (DCGI).
The committee added that Zydus needs to submit additional data for the 2-dose regimen of its vaccine.
Cadila Healthcare Ltd, applied for authorisation of the vaccine ZyCoV-D on July 1, based on an efficacy rate of 66.6% in a late-stage trial of more than 28,000 volunteers nationwide.
This was the first time that any COVID-19 vaccine has been tested in the adolescent population in the 12-18 years age group in India. Around 1000 subjects were enrolled in this age group and the vaccine was found to be safe and very well tolerated. The tolerability profile was similar to that seen in the adult population.
If approved, Zydus Cadila’s vaccine will be the second home-grown shot to get emergency authorisation in India after Bharat Biotech’s Covaxin and would become the fifth vaccine cleared for use in the country after locally produced Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V and the US-made Moderna.
ZyCoV-D is the world’s first plasmid DNA vaccine for human use if approved.
ZyCoV-D is a plasmid DNA vaccine that produces the spike protein of the SARS-CoV-2 and elicits an immune response mediated by the cellular (T lymphocytes immunity) and humoral (antibody-mediated immunity) arms of the human immune system.
The vaccine has shown efficacy of 66.6% against symptomatic Covid cases and 100% for moderate disease. It is an intradermal vaccine, applied using a ‘needle-free injector’. Zydus claims the needle-free system can lead to a significant reduction in side effects.