An expert panel on Tuesday recommended Bharat Biotech’s COVID-19 vaccine Covaxin for phase II/III clinical trials on children aged two to eighteen years, according to official sources. The trial will include 525 subjects and will take place at various locations, including AIIMS in Delhi, AIIMS in Patna, and Meditrina Institute of Medical Sciences in Nagpur.
The Central Drugs Standard Control Organization’s (CDSCO) Subject Expert Committee (SEC) on COVID-19 met on Tuesday to discuss Hyderabad-based Bharat Biotech’s application for permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity, and immunogenicity of Covaxin jabs in children aged 2 to 18 years.
Previously, the proposal was discussed at the SEC meeting on February 24, and the company was asked to submit a revised clinical trial protocol. Covaxin, which was developed indigenously by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is currently being administered to people over the age of 18 as part of a nationwide vaccination campaign against COVID-19.
Amid the apprehension of an ominous third wave, the DGCI’s approval for the next phase of the trial will bolster India’s fight against the pandemic. Battling shortage of Covid-19 vaccines across the country, the govt panel recommended that the gap between the two jab of Covishield, which was earlier six to eight weeks. The panel has urged Covid recovered patients to defer vaccination for 6 months.