Expert Panel Recommends Covaxin For Next Phase Of Trials For 2-18 Age Group: Report

Covaxin trials for children: Covaxin, developed by Hyderabad-based Bharat Biotech, has been given a nod by an expert panel for phase-2 and phase-3 clinical trials on those aged between two to 18 years, official sources said on Tuesday. On May 12, India reported 3,48,42 lakh new cases, 4,205 deaths in the last 24 hours.

The coronavirus vaccine is currently being used for those above 18 years of age in India amidst the ongoing COVID-19 vaccination drive. Covaxin has now been recommended to go through another clinical trial that will take place at various institutes across India. The trials will be done on 525 subjects at Delhi's AIIMS and Meditrina Institute of Medical Sciences, Nagpur among others.

Bharat Biotech has been seeking permission to conduct phase II/III clinical trials to evaluate the safety of Covaxin jabs in children aged 2 to 18 years for some time now. It finally received a recommendation from the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Tuesday.

The committee said that after detailed deliberation the members have recommended conducting the proposed clinical trial for the firm to submit the interim safety data along with the Data and Safety Monitoring Board (DSMB) recommendations to the CDSCO before proceeding to phase III part of the study, reported ANI.

Subject Expert Committee (SEC) gives nod to Bharat Biotech's Covaxin for phase 2 and 3 human clinical trials on 2 to 18-year-olds: Sources#COVID19 pic.twitter.com/0FD1y3IGYh

— ANI (@ANI) May 12, 2021

Earlier, United States’ top pandemic expert Dr Anthony Fauci had confirmed that Covaxin, India’s home-grown coronavirus vaccine, has been found to neutralise the B.1.617 variant or ”double mutant” of the deadly virus, first detected in India, in October last year. The White House chief medical adviser also stressed that the most recent data shows that it has the efficacy to fight the new variant of the virus, hence the vaccination could be a “very important antidote” for India's COVID-19 second wave crisis.

India has so far given more than 100 million doses of two approved vaccines – Covishield and Covaxin.