The Drugs Controller General of India (DCGI) on Tuesday approved the restricted emergency use authorisation (EUA) to Bharat Biotech’s Covaxin for children between the age of 6-12 years, sources said.
The DGCI has asked vaccine manufacturer to submit safety data including the data on adverse event with due analysis every 15 days for the first two months and monthly thereafter upto 5 months, said the source familiar with the development.
This development comes after the Subject Expert Committee (SEC) discussed recommendations for the restricted emergency use of Covaxin in children aged between 2-12 years.
ALSO READ: Bharat Biotech Upgrading Facilities as WHO Suspends Covaxin Supplies
However, the SEC, after a meeting on Thursday, had recommended restricted emergency use of Biological E’s Covid-19 vaccine, Corbevax, in children aged 5-12 years.
(This story has been sourced from a third-party syndicated feed, agencies. Raavi Media accepts no responsibility or liability for the dependability, trustworthiness, reliability, and data of the text. Raavi Media management/ythisnews.com reserves the sole right to alter, delete or remove (without notice) the content at its absolute discretion for any reason whatsoever.)