New Delhi:
Covaxin Phases 2 & 3 Clinical Trials for Children: Official sources said that Covaxin, the COVID-19 vaccine developed by Bharat Biotech s in collaboration with the Indian Council of Medical Research (ICMR), was on Tuesday recommended by an expert panel for phase-2 and phase-3 clinical trials on those aged between 2 and 18 years.
Sources said that 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.
Covaxin has been developed by Hyderabad-based Bharat Biotech.
New Delhi:
Bharat Biotech s COVID-19 vaccine Covaxin was on Tuesday recommended by an expert panel for phase-2 and phase-3 clinical trials 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 Organization (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.
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 Organization (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 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 recommen
: Wednesday, May 12, 2021, 8:33 AM IST
COVID-19 Vaccine in India: Bharat Biotech s Covaxin recommended for Phase II/III trials on 2 to 18 year-olds
(Photo by AFP)
While India expanded it s COVID-19 vaccination drive to include all adults at the beginning of May, children have remained excluded from both trials and the inoculation drive for the most part. That however is now set to change, with an expert panel recommending Bharat Biotech s Covaxin for phase II/III clinical trial on those aged between two to 18 years.
As per reports, 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 Organization (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 Covaxi