Covaxin received nod from experts for emergency use for kids aged 2 years and above. The central drug regulator’s expert panel has recommended use of Covaxin, a Covid-19 vaccine manufactured by India’s Hyderabad based Bharat Biotech Company with certain conditions and criterion.
Expert committee on Covid-19 recommended granting marketing authorisation as the Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below aged 18 years in September and submitted the data to experts for further recommendations.
However, the final approval of EUA (Emergency Use Authorisation) from the drug regulator and expert will take some more days as the data submitted by the company will be reviewed and evaluated for final conclusion and immunization program to start for children.
Along with Covaxin, ZyCov-D (three-dosed needle free vaccine) manufactured by Zydus Cadila drugmaker company based in Ahmedabad India has received nod from experts for paediatric population above 12 years of age. In addition, Pune based vaccine manufacturing company Serum Institute of India has started phase 2 and phase 3 trials for Covovax for children aged between 7 to 11 years.
Subject Expert Committee has prescribed conditions and recommendation to Bharat Biotech which comprise of continuation of clinical trials by the company for further review. The company has also been asked to submit data on package insert, characteristics of product, summary and information of and further updates prescribing information.
The Firm will have to submit adverse event data and risk management plan every 15 days for few months as per the recommendations of drug regulator and SEC.