The City Headlines
Ludhiana, October 12
The Subject Experts Committee (SEC) on COVID-19 has reportedly granted emergency use approval to Covaxin for children aged 2-18.
According to the reports, Bharat Biotech’s Covaxin has completed phase 2 and phase 3 of the trial on children below 18.
The reports also suggest that the vaccine would be administered in two doses with a gap of 20 days.
Bharat Biotech, in a statement reportedly said, “This represents one of the first approvals for the coronavirus vaccines for the 2-18 age group. We sincerely thank the DCGI, Subject Experts Committee, and CDSCO for their expedited review process. We now await further approvals from the CDSCO prior to product launch and market availability of Covaxin for children.”
The emergency use of the vaccine is subject to several conditions. The reports also suggest that the developer firm would have to submit safety data along with AEFI and AESI every 15 days for the first two months.
The World Health Organization has still not given any emergency use approval to Covaxin. Bharat Biotech had reportedly submitted all the required documents by July 9. By July end, WHO’s review process had started which usually continues for six weeks.
