COVAXIN's phase-2 clinical trials on children aged 2-18 yrs begin at Patna's AIIMS

As India's vaccination drive picks up pace, Bharat Biotech (BBL) on Wednesday started its phase-2 trials of COVAXIN at Patna's AIIMS hospital in Bihar. The trial will 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.

Covaxin trials on children begins

On May 13, the Drugs Controller General of India (DCGI) had given nod to phase-2/3 trials on children aging 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 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.

The COVAXIN journey

In March, Bharat Biotech said that its COVID-19 vaccine - Covaxin - a Whole Virion Inactivated Corona Virus Vaccine - 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 in 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.

After Subject Expert Committee (SEC)'s nod to COVAXIN several politicians had questioned why Phase 3 trials protocol have been modified for the Bharat Biotech vaccine candidate, urging Health Minister Harshvardhan to clarify on the same. Meanwhile, Tharoor stated that the DCGI 'approval was premature and could be dangerous', opining that its use should be avoided till full trials are over. Several others have questioned the vaccines due to 'lack of trust' on Modi govt. Recently, as the vaccination drive picked up, direct supply of Covaxin to most states has commenced.

Moreover in April, 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 too 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.