Covaxin approved for Phase 2 & 3 Trials on 2-18 year-olds
Covaxin gets approval for phase 2/3 trials on 2-18 year-olds
TNI Bureau: Hyderabad-based Bharat Biotech has been granted permission to conduct the phase 2 and phase 3 clinical trials of its COVID-19 vaccine ‘Covaxin’ on children between the 2 to age 18.
The trials will be conducted in 525 subjectes at various testing sites, including AIIMS (New Delhi), AIIMS (Patna) and Meditrina Institue of Medical Sciences (Nagpur), Maharashtra.
According to available sources, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) took this decision after the Bharat Biotech sought permission to conduct phase 2 and 3 clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.
Earlier, the Bharat Biotech was asked to submit a revised clinical trial protocol after the SEC held a meeting on February 24 to discuss the proposal.
It is worth noting that ‘Covaxin’ is India’s first indigenous COVID-19 vaccine and developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (IMCR). It is now being used in adults above 18 years of age in the ongoing nationwide vaccination drive against COVID-19.