New Delhi: Indian drug regulators will consider the approval of emergency use for the Covid-19 vaccine developed by Zydus Cadila for children above 12.
Regulator’s Subject Expert Committee (SEC) will check the data delivered by Cadila.
This vaccine has been tested in adults and children over 12 and if the regulatory committee with data and documents delivered, the vaccine will soon be approved for emergency use, officials said.
Approval can accelerate the opening of the school even though the vaccine supply will remain a concern.
“The initial assessment of the application submitted by the company is ongoing and we have sent it to the SEC for further consideration.
The SEC will meet in the coming week, the company’s representative will also be asked to make a presentation,” said an official.
If the SEC finds the data phase 3 sent by a satisfying company, authorization of emergency use for vaccines can be given this week itself.
The official said that after approval was given, the vaccine supply is expected to begin in August-September.
If you get a nod, Zycov-D, the DNA-developed vaccine candidate will be a fifth vaccine against Coronavirus to get EUA in India.
At present, Covishield, Covaxin and Sputnik V are being given under the Covid-19 National Immunization Program.
Cipla also has EUA to import anti-covid jab mode but not yet available in this country.
Zycov-D is a three-dose intradermal vaccine applied using a pharmajet needle-free system.
This can be stored on Celsius 2-8 degrees and has shown good stability at a temperature of 25 degrees Celsius for a minimum of 3 months.
While Zydus Cadila has indicated that it will initially produce a dose of crore per month and then increase production, the availability of vaccines will be a boost to supply and cover for children 12-18 years, especially after concern about the potential of the third wave when children are seen vulnerable to viruses.
In addition, the government can also focus on inoculation of children going forward because it will be very important to open school.
Apart from Cadila, Bharat Biotech also tested Covaxin in children.