AIIMS Delhi to begin screening for clinical trials of Covaxin on children from June 7

After All India Institute of Medical Sciences (AIIMS), Patna, now AIIMS Delhi will start the screening for clinical trials of Bharat Bitotec's Covaxin COVID-19 vaccine on children from Monday (June 7), as per ANI sources. The trial is planned to take place on 525 subjects at various sites, including AIIMS (Delhi), AIIMS (Patna), and Meditrina Institute of Medical Sciences, Nagpur with two doses administered in an interval of 28 days. Covaxin will be the first such vaccine in India that would cater to inoculating children.

AIIMS Delhi starts COVAXIN's Clinical Trials On Children from Monday

COVAXIN's Phase-2 Clinical Trials On Children Aged 2-18 Yrs Begin At Patna's AIIMS

Director of  AIIMS Patna Prabhat Kumar Singh said, "AIIMS Patna has started trials in the age of 12-18 years, we have started clinical trials of Covaxin after registration for this age only.'' He added," After these trials, the age group will be 6-12 years and then 2-6 years but right now we have just started with the trials in the age group of 12-18 years.'' 

On May 13, the Drugs Controller General of India (DCGI) had given nod to phase-2/3 trials on children ageing 2-18-year-olds. In a recent virtual conference, Dr Raches Ella had hinted at the commencement of pediatric trials of its COVID-19 vaccine Covaxin from June. The company is also expecting approval from the World Health Organization (WHO) for Covaxin by the end of the third or fourth quarter, further informed Dr Ella. BBL also plans on ramping up the manufacturing capacity to 700 million doses by the end of this year.

Covaxin's Journey

In March, Bharat Biotech said that its COVID-19 vaccine- Covaxin has shown an interim clinical efficacy of 81% in its Phase 3 trials. The phase 3 trials involved 25,800 subjects and is the largest ever trial conducted in India. COVAXIN has been granted permission for restricted use in an emergency situation by the DGCI on January 3. Union Health Minister Dr Harsh Vardhan explained that COVAXIN is more likely to work against newer variants like N501Y Variant (UK variant) and the recent double mutation (Indian variant). The participants enrolled were between the age of 18-98 years old including 2,433 over the age of 60 and 4,500 with comorbidities.

In April, the Centre has approved an advance payment of Rs 4,567.50 crores to Serum Institute of India (SII) & Bharat Biotech (BBL) to ramp up COVID-19 vaccine production. Apart from Bharat Biotech, three public sector companies - Haffkine Biopharmaceutical Corporation Ltd, Mumbai, Indian Immunologicals Limited, Hyderabad and Bharat Immunologicals & Biologicals Limited, Bulandshahr to have been given grants to enhance their production capacity. While Haffkine will produce 20 million doses per month within six months, the other two will produce 10-15 million doses per month by Aug-Sep 2021.

(Image Credits: PTI/RepresentationalImage)