New Delhi | Jagran News Desk: In another shot in the arm for India's COVID-19 vaccination drive, the Subject Expert Committee (SEC) on COVID-19 vaccines on Tuesday has recommended the use of Bharat Biotech's Covaxin for emergency use for children aged 2 to 18 year age group with certain conditions. The recommendation has been sent to the Drugs Controller General of India (DCGI), which will take a final call on the emergency use authorisation of the vaccine.
Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of Covid vaccine Covaxin for use in children aged between 2 and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab at the beginning of this month.
In its report, Bharat Biotech has also requested for the grant of market authorisation of its Whole Virion, Inactivated coronavirus Vaccine (BBV152) in the 2 to 18 years age group for restricted use in an emergency situation. The overall geometric mean titre (GMT) for the paediatric population is comparable with GMT of the adult population in phase -3 efficacy study, the recommendations by the expert panel stated.
After detailed deliberation, the committee recommended the grant of market authorisation of the vaccine for the 2 to 18 years age group for restricted use in emergency situations subject to certain conditions. According to the conditions, the firm should continue the study as per the approved clinical trial protocol and provide updated prescribing information/package Insert (Pl), Summary of Product Characteristics (SmPC) and Factsheet.
Besides, the firm should submit safety data, including the data on AEFI and AESI, with due analysis, every 15 days for the first two months and monthly thereafter and also as per the requirement of New Drugs and Clinical Trials Rules, 2019.
Meanwhile, India's COVID-19 vaccination coverage has crossed 95 crores. The nationwide vaccination drive started in India on January 16 with the healthcare workers (HCWs) and the frontline workers getting inoculated in the first phase.
The next phase of COVID-19 vaccination commenced from March 1 for people over 60 years of age and those aged 45 and above with specified co-morbid conditions. The country launched vaccination for all people aged more than 45 years from April 1. The government then decided to expand its vaccination drive by allowing everyone above 18 to be vaccinated from May 1.
(With Agencies Inputs)
Posted By: Talibuddin Khan