on Jul 12, 2021)The drug regulator will consider emergency use approval for Covid vaccines developed by Zydus Cadila for children above 12 this week. The regulator’s subject expert committee (SEC) will examine data submitted by Cadila, reports Sushmi Dey.
The Zydus
vaccine has been tested on adults as well as on children above 12 and if the regulatory panel is satisfied with the data and records submitted by the firm, the vaccine will be approved for emergency use soon, officials said. An approval can hasten the opening of schools although vaccine supply will remain a concern.
“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,” an official said.
If the SEC finds the phase 3 data submitted by the company satisfactory, the emergency use authorisation for the vaccine can be granted this week itself.
The official said that once approval is given, supply of the vaccine is expected to start by August-September.
ZyCov-D is a three-dose intradermal vax
The official said that once approval is given, supply of the vaccine is expected to start by August-September. If it gets the nod, ZyCov-D, a locally developed DNA vaccine candidate would be the fifth vaccine against coronavirus to get EUA in India. Currently, Covishield, Covaxin and Sputnik V are being administered under the national Covid-19 immunisation programme. Cipla has also got an EUA to import Moderna’s anti-Covid jab but it is yet to be available in the country.
ZyCoV-D is a three-dose, intradermal vaccine which is applied using the PharmaJet needle-free system. It can be stored at 2-8 degree Celsius and has shown good stability at temperatures of 25 degree Celsius for at least 3 months. While Zydus Cadila has indicated it will initially manufacture one crore doses per month and later increase production, the vaccine’s availability will be a boost to supplies as well as offer cover to children of 12-18 years, particularly in the wake of concerns about a potential third wave as children are seen to be vulnerable to the virus.
