In the fight against the corona pandemic in the country, now children can get good news in the coming days. An expert committee on Tuesday recommended a trial for the second / third phase of Bharat Biotech’s Covid-19 vaccine Covaxin for ages 2-18.
The decision has come just a day after the Subject Expert Committee of the Drugs Controller General of India recommended that the vaccine be given approval for further trials on children.
Official sources gave this information. He told that this trial will be done at various places including AIIMS in Delhi and Patna and the Meditrina Medical Science Institute in Nagpur.
The Covid-19 Subject Expert Committee of the Central Drugs Standard Control Organization (CDSCO) on Tuesday discussed the application made by Bharat Biotech to increase the safety and immunity of its covaxine vaccine in 2-to-18-year-old children.
Bharat Biotech had proposed to carry out a Phase-II/III clinical trial of Covaxin in the age group of 2 to 18 years. Notably, the trial will be conducted in 525 healthy volunteers.
According to reports, In the trial the vaccine will be given by intramuscular route in two doses at day 0 and day 28. As a rapid regulatory response, the proposal was deliberated in the SEC on May 11. The committee after detailed deliberation recommended for the grant of permission to conduct a proposed Phase II/III clinical trial to certain conditions.
The Covid Subject Expert Committee of the Central Pharmaceutical Standards Control Organization considered the application in which India Biotech was allowed to allow the second / third phase of testing for children between the age of 2 years to 18 years. .
Bharat Biotech has started the work of delivering covid vaccine in various states of the country in full swing. Information about this company has been shared by tweeting itself.
“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 said.
