India's expert panel recommends Covaxin trials on 2-18 year-olds
With 525 participants, the trial is expected to take place at various sites, including AIIMS Delhi
India's expert panel of Central Drugs Standard Control Organization(CDSCO) has recommended Bharat Biotech’s COVID-19 vaccine, Covaxin for second and third phase trials in children aged between two to eighteen years of age.
With 525 participants, the trial is expected to take place at various sites, including AIIMS Delhi, AIIMS Patna, and Meditrina Institute of Medical Sciences, Nagpur.
On Tuesday, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization deliberated on an application submitted by Hyderabad-based Bharat Biotech. The application sought permission to conduct Phase 2 and 3 trials in children aged 2 to 18 years.
The clinical trials will evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children.
"After detailed deliberation, the committee recommended for 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 told PTI.
The proposal was earlier contemplated over in an SEC meeting on February 24 wherein the firm was asked to submit a revised clinical trial protocol.
Covaxin is an indigenously developed vaccination by Bharat Biotech developed in collaboration with the Indian Council of Medical Research (ICMR), the vaccine is already in use for adults in India's ongoing COVID-19 vaccination drive.
(With inputs from agencies)