All India Institute of Medical Sciences (AIIMS) Delhi to start recruitment for clinical trials from June 15 onwards for the children who are in the age group of 6-12 years, news agency ANI has reported.
The report further said that the clinical trial of children of 2-6 age group will start after that.
AIIMS Delhi has completed the clinical trial for a single dose of Covaxin for the 12-18 age group, it said.
AIIMS Delhi to start recruitment for clinical trials tomorrow onwards on 6-12 age group children and 2-6 age group after that. Trial for 6-12 age group to start from tomorrow. Recruitment & clinical trial for single-dose COVAXIN for 12-18 age group is over.— ANI (@ANI) June 14, 2021
The screening of children for trial of Covaxin, India's first indigenously developed COVID-19 vaccine among those aged between 2 and 18 had started at AIIMS Delhi on June 7.
As per an Indian Express report, the Centre is targeting to cover 80 percent of the 130 million people falling in the 12-18 age group as part of the COVID-19 vaccination drive for children. Thus, the government would need to procure around 210 million shots of a two-dose COVID-19 vaccine.
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While Pfizer-BioNTech’s jab has been approved in the European Union for use in the 12-15 age bracket, the news report suggests that Covaxin, the COVID-19 vaccine developed by Bharat Biotech, would be used in India for this purpose.
The Drugs Controller General of India (DCGI) had granted permission to Bharat Biotech for conducting trials of its COVID-19 vaccine on children. The DCGI's approval came after a recommendation by a Subject Expert Committee (SEC) on May 12.
Recently, AIIMS Patna too started a similar trial for Bharat Biotech's coronavirus vaccine on children aged between 12 and 18.
The trial will take place in 525 subjects at various sites, including AIIMS Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences, Nagpur.
Meanwhile, a plea has been moved in the Delhi High Court seeking a stay on phase II/III clinical trials of Covaxin on the 2-18 age group.
The application was moved in a petition filed in May for setting aside the permission granted by the DCGI to Bharat Biotech for conducting trials of its vaccine on children.
The petitioner, Sanjeev Kumar, had raised an apprehension that the children who would be part of the trial could suffer adverse health or mental effects due to the testing of the vaccine on them.
He has claimed in his application that while the issue was pending before the high court with notices issued to the Centre and Bharat Biotech, the trials have commenced from June.
Kumar has contended that on July 15, the next date of hearing of the petition, the government and the company would say that the trials have commenced and thus, the plea challenging the permission granted by DCGI would become infructuous.
Meanwhile, Centre plans to vaccinate all adults by the end of this year.
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