Patna: In a major development, Bharat Biotech has begun clinical trials of its COVID-19 vaccine on children aged 2 to 18 years at All Indian Institute of Medical Sciences (AIIMS) in Patna. The trials commenced after the Drugs Controller General of India’s (DCGI) nod for the Phase 2 and 3 clinical trials of Covaxin on children on May 11.
The trials are also slated to take place in 525 subjects at various sites, including AIIMS, Delhi, and Meditrina Institute of Medical Sciences, Nagpur.
Earlier this month, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) had deliberated upon Hyderabad-based Bharat Biotech’s application seeking 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.
“After detailed deliberation, the committee recommended for the conduct of proposed phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study,” a source had told news agency PTI.
Earlier the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol.
Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in India’s ongoing COVID-19 vaccination drive.
India started the world’s largest vaccination drive on January 16 this year in a phased manner with healthcare workers (HCWs) getting inoculated first. The vaccination of frontline workers (FLWs) started on February 2.
The next phase of Covid-19 vaccination commenced from March 1 for those over 60 years of age and for people aged 45 and above with specified co-morbid conditions. India launched vaccination for all people aged more than 45 from April 1.
The third phase of the vaccination started on May 1 for the beneficiary aged between 18-44.
