Bharat Biotech’s COVID-19 vaccine Covaxin was on Tuesday recommended by an expert panel for phase II/III clinical trial on those aged between two to 18 years, official sources said.
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna, and Meditrina Institute of Medical Sciences, Nagpur.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Tuesday 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 said.
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.
Bharat Biotech has commenced direct supply of its COVID-19 vaccine ‘Covaxin’ to 14 states, including Delhi and Maharashtra, with effect from May 1, according to the company’s Joint Managing Director Suchitra Ella.
The Hyderabad-based firm has started supplying its COVID-19 treatment vaccine to the states based on the allocations received by the central government.
“Bharat Biotech confirms direct supplies of COVAXIN to the following state governments since 1/5/21, based on the allocations received by GoI. Requests have been received from other states, & will be processed for distribution based on the availability of stocks 24×7,” Ella tweeted.
(Disclaimer: Additional background information has been added to this PTI copy for context)
