Covaxin's Phase II & III clinical trials for 2-18 year old to begin in 10-12 days

Hyderabad-based Bharat Biotech's COVID-19 vaccine, Covaxin's Phase II/III clinical trials for the age group of 2 to 18 years will begin in 10 to 12 days. Dr VK Paul, Member, NITI Aayog, on Tuesday said, "I have been told that trials will begin in the next 10-12 days," during a press briefing on COVID-19.

The national regulator Drugs Controller General of India (DCGI) had last week given its nod to Bharat Biotech in this matter. The trial will be conducted on 525 healthy volunteers.

As a rapid regulatory response, the proposal was deliberated in the Subject Expert Committee (SEC) on May 11. The committee after detailed deliberation recommended for the grant of permission to conduct Phase II/III clinical trial, subject to certain conditions.

This would be the first time in the country when a COVID-19 vaccine will be tested on children. The clinical trials will involve two COVID vaccine shots injected on day 0 and day 28 and will take place at several sites -- AIIMS, Delhi; AIIMS, Patna; and Meditrina Institute of Medical Sciences, Nagpur.

Apart from Bharat Biotech's Covaxin, Serum Institute's Covishield and Russia's Sputnik V are also being used to vaccinate people in India. However, Sputnik V is being administered only to the beneficiaries who are 45 years or older.

Reports also suggest that the Russian Direct Investment Fund (RDIF) - Russia's sovereign wealth fund that financed Sputnik V - will soon launch its single-dose COVID vaccine Sputnik Light in India. "We hope for the introduction of Sputnik V Light in India soon," Kirill Dmitriev, CEO, RDIF, had said last week.

Meanwhile, India has reported a significant decline in daily COVID-19 cases in the past 24 hours at 2,63,533. The death toll rose to its highest at 4,329, as per MoHFW data. As many as 4,22,436 patients recovered from the disease in the past one day, the data further shows. The daily new COVID-19 cases went below 3 lakhs after 26 days on Monday.

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