Bharat Biotech gets nod for Covaxin trials on 2-18 age group: Report

India’s indigenous COVID-19 vaccine, developed by Hyderabad-based Bharat Biotech, has been given the nod to conduct phase II and III on 2 to 18-year-olds. The Subject Expert Committee (SEC) of Central Drugs Standards Control Organisation (CDSCO) has approved the clinical trial of Covaxin, PTI reported quoting sources. 

Also read: COVID-19 vaccine, Covaxin, 81% effective in phase 3 trials: Bharat Biotech

The trials will be conducted in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur, according to the news agency.

Bharat Biotech’s proposal for clinical trials on 2 to 18-year-olds was discussed during the SEC meeting on February 24. The expert panel had then asked the firm to submit a revised clinical trial protocol.

Covaxin is currently being administered in India’s mass vaccination drive against COVID-19. It has been developed by Bharat Biotech, in collaboration with the Indian Council of Medical Research.

Also read: A comparison of Covishield and Covaxin: COVID-19 vaccines approved by India

The other vaccine currently being administered in India is the one developed by AstraZeneca/University of Oxford.