The subject expert committee (SEC) of Drugs Controller General of India (DCGI) has recommended granting emergency use approval (EUA) to Zydus Cadila’s three-dose COVID-19 vaccine for children above the age of 12.
ZyCoV-D is a first-of-its-kind DNA vaccine which produces spike protein of SARS-CoV-2 for immune response. An intradermal vaccine, it has to be applied with a needle-free injector which will help in reducing side-effects.
ZyCoV-D is the first vaccine for children above 12 in India and also the country’s second indigenous coronavirus vaccine – after Bharat Biotech’s Covaxin – to be granted emergency use authorisation.
Ahmedabad-based generic drug maker Cadila Healthcare Ltd had applied for emergency use approval of ZyCoV-D on July 1. A late-stage trial, conducted on more than 27,000 volunteers across India in over 50 trial centres had shown an efficacy of 66.6%.
ZyCoV-D has also been tested on 1,000 children above the age of 12.
Cadila Healthcare earlier said that its two-dose vaccine works as well as the three-dose regime, and has submitted data for scrutiny.
It’s the sixth vaccine to be approved in the country so far, joining the leagues of Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V and the US-made Moderna and Johnson & Johnson. Sharvil Patel, managing director, Cadila Healthcare, said that if approved the vaccine can be used to inoculate not only adults but also adolescents between the ages of 12-18.
