New Delhi: Gujarat-based pharmaceutical company Zydus Cadila’s Covid-19 vaccine for kids, ZyCoV-D, is likely to get emergency use approval from India’s drug regulator Drugs Controller General of India (DCGI) within a few days, said sources. The ZyCoV-D vaccine developed for children above 12 years is a three-dose, intradermal vaccine, and is needle-free, also leading to a significant reduction in any kind of side effects. Interim analysis has shown it to be 66.6 per cent effective for symptomatic RT-PCR positive cases.Also Read - Tamil Nadu Lockdown Update: Govt Extends Restrictions Till August 9, Check What’s Allowed, What’s Not
Speaking to news agency ANI about its emergency use approval, sources said, “Subject Expert Committee (SEC) is expected to meet this week and will review the data. However, final approval for EUA will be given only after a few meetings.” The sources further informed that the DCGI’s SEC will examine data submitted by Zydus Cadila for children above 12 years. But if data found to be satisfied then final approval from DCGI may be granted in few days. Also Read - Maharashtra Lockdown: Rajesh Tope Makes BIG Announcement; Restrictions on Saturdays To Be Lifted | Other Details Inside
Officials further said that if the approval is given, the supply of the vaccine is expected to begin by August-September. Speaking to TOI, an official said, “The preliminary assessment of the application submitted by the company is going on and we have sent it to the SEC for further consideration. The SEC will be meeting in the coming week, representatives of the company will be also asked to make presentations.” Also Read - Mumbai Local Train Latest Update: Maharashtra Govt's Decision on Allowing Unrestricted Travel for Fully Vaccinated Citizens to be Announced Soon
ZyCoV-D is the world’s first Plasmid DNA vaccine, which carries the genetic code for that part of a virus that triggers the immune system of the body. According to sources, the continuous and rolling review of data is ongoing and even if SEC meeting takes place this week then final approval will take few more days.
Earlier, on Friday, Dr VK Paul, Member (Health) of the NITI Aayog said that a decision on the approval of Zydus Cadila’s COVID-19 vaccine is expected soon, adding that the data and evaluation would determine the outcome.