The COVID-19 vaccine developed by Zydus Cadila for kids above 12 years is reportedly set to attain emergency use approval from the Drugs Controller General of India (DCGI) over the upcoming days.
The vaccine has been tested on both adults as well as children above the age of 12 years. If the regulators are satisfied with the data, they might approve the vaccine for emergency use, as apparently stated by officials.
The Subject Expert Committee (SEC) of the regulators will evaluate the data submitted by Zydus. The officials apparently stated that if the vaccine receives approval, its supply is expected to commence by August-September.
The official supposedly commented that the application submitted by the company is being assessed and has been sent to the SEC for further evaluations. Over the coming week, the SEC will have a meeting and company representatives will be asked to present the proposal.
Earlier, the Chairperson of National Technical Advisory Group on Immunization (NTAGI)’s COVID-19 Working Group, Dr. N.K. Arora, apparently stated that Zydus’s COVID-19 vaccine for kids aged 12 to 18 years is predicted to be available by the end of September. Dr. Arora also supposedly mentioned that by next month or September, the company’s data for 12 to 18-year-olds will certainly be available.
The Managing Director of Zydus Group, Dr. Sharvil Patel, reportedly commented that the company will commence the supply of the vaccine once it receives approval from the regulators. Dr. Patel further added that Zydus Cadila will initially produce around one crore doses per month and will increase the manufacturing over the coming months.
If the vaccine receives approval from the regulatory committee, ZyCov-D will be the fifth COVID-19 vaccine to obtain the Emergency Use Authorization (EUA) in India.
ZyCov-D is an intradermal, three-dose vaccine that is administered using the PharmaJet needle-free system. Apart from Zydus Cadila, Bharat Biotech is also testing its vaccine, Covaxin, on children.