AIIMS Delhi to start screening children aged 6-12 years for Covaxin trials from Tuesday

The screening of children aged 6 to 12 years for clinical trials of Bharat Biotech's Covaxin, an indigenously developed COVID vaccine, is set to begin on Tuesday, June 14. The enrollment for Covaxin clinical trials among those aged 12 to 18 years has ended, according to reports. A single dose of vaccination was administered to them. Following the recruitment of children aged 6 to 12, the All India Institute Of Medical Science (AIIMS) Delhi will undertake trials for children aged 2 to 6. The trials are being held at 525 locations. Children's clinical studies are also being conducted at AIIMS Patna, Mysore Medical College, and Research Institute in Karnataka.

AIIMS Delhi to start Covaxin trials screening in children

Prabhat Kumar Singh, Director, AIIMS, Patna informed, "We have started recruitment for children aged 6-12 years. Recruitments for clinical trials on children aged 12-18 years are over. They will be kept under observation."

The vaccine's safety, reactogenicity, and immunogenicity in children will be assessed in clinical trials. On May 12, the Drugs Controller General of India (DCGI) approved the phase 2/3 clinical study of Bharat Biotech's Covaxin in children aged two to eighteen years. The trial will be divided into three sections, each with 175 volunteers aged 12-18, 6-12, and 2-6 years. The vaccine will be administered intramuscularly in two doses on days 0 and 28 of the experiment.

About Bharat Biotech's Covaxin 

Bharat Biotech announced in March that its COVID-19 vaccine, Covaxin, had achieved interim clinical effectiveness of 81% in Phase 3 trials. The phase 3 trials, which enrolled 25,800 people, were the largest ever done in India. On January 3, the DCGI gave COVAXIN authorization for limited usage in an emergency scenario. COVAXIN is more likely to function against newer variants like the N501Y Variant (UK variant) and the recent double mutation  (Indian variant), according to Union Health Minister Dr Harsh Vardhan. The participants ranged in age from 18 to 98 years old, with 2,433 over the age of 60 and 4,500 having comorbidities.

The Centre granted a Rs 4,567.50 crore advance payment to Serum Institute of India (SII) and Bharat Biotech (BBL) in April to boost COVID-19 vaccine manufacturing. Aside from Bharat Biotech, three public sector businesses - Haffkine Biopharmaceutical Corporation Ltd, Mumbai, Indian Immunologicals Limited, Hyderabad, and Bharat Immunologicals & Biologicals Limited, Bulandshahr - have received funding to expand their manufacturing capacity. By August-September 2021, Haffkine will be producing 20 million doses per month, while the other two will be producing 10-15 million doses per month.

(with inputs from ANI)

Picture credit: PTI