The Subject Expert Committee(SEC) of drug regulator recommended for granting emergency use authorisation to Covaxin manufactured by Bharat Biotech for children between ages 2 – 18.
The SEC submitted its recommendation to the Drugs Controller General of India(DCCI) for final approval.
The nod for emergency use comes attached with four conditions :
1) Biotech will continue the study as per Whole Vrion, Inactivated Corona Virus Vaccine the approved clinical trial protocol
2) The firm should provide updated Prescribig Information/Package Insert(PI), Summary of Product Characterstics(SmPC) and Factsheet
3) The firm should submit safe data, including the data on AEFI and AESI, with due analysis, every 15 days for the first two months and monthly thereafter.
4) The firm should submit risk management plan as per requirement of New Drugs & Clinical Trials Rules 2019.
