Bharat Biotech, which completed the Phase 2/3 trials of COVID-19 vaccine Covaxin for use in children under 18 years of age last week, has received the Subject Expert Committee’s nod for administering the drug to kids.The Hyderabad-based biotechnology company had last week submitted the data to the Central Drugs Standard Control Organisation for its verification and subsequent approval for Emergency Use Authorisation for the jab. With this, Covaxin becomes the first COVID-19 vaccine that can be administered to children in India.Meanwhile, the World Health Organisation (WHO) is yet to take a call on granting Emergency Use Listing (EUL) status for Covaxin. The global health body is likely to a final call this week.Bharat Biotech has been submitting data to WHO on a rolling basis and submitted additional info at WHO’s request on September 27. WHO experts are currently reviewing this info & if it addresses all questions raised, the WHO assessment will be finalized next week.According to the WHO, its officials and an independent group of experts are scheduled to meet this week to carry out the risk/benefit assessment before taking a final decision on whether to grant Emergency Use Listing to Covaxin. The Emergency Use Listing process – done by WHO and the Technical Advisory Group of independent experts – is centred on determining if a manufactured product is quality-assured, safe and effective.The indigenously developed Bharat Biotech’s Covaxin is one of the six vaccines that have received emergency use authorisation from India’s Drug Regulator and is being used in the nationwide anti-COVID-19 inoculation programme along with Covishield and Sputnik V.
