DCGI nod to Phase II/III clinical trial of Bharat Biotech’s Covaxin among 2-18 yr olds


The Phase 2-3 clinical trials of Covid-19 vaccine, Covaxin, which has been approved by the Drugs Controller General of India (DCGI), for in the age group of 2 to 18 years, will begin in the coming 10 to 12 days, Dr VK Paul, Member, NITI Aayog said.

“I have been told that trials will begin in the next 10-12 days,” Dr VK Paul said on Tuesday during a press briefing on Covid-19.

This is the first time in India that a Covid-19 vaccine will be tested on children.

The clinical trials involve two Covid-19 vaccine shots injected on day 0 and day 28.

The trials will take place at several sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.

India’s drug regulator has accepted the recommendation of the Subject Expert Committee (SEC) and given a nod to the Hyderabad-based Bharat Biotech to conduct Phase II/III clinical trial of Covid-19 vaccine Covaxin in the age group 2 to 18 years.

Covaxin maker Bharat Biotech had proposed to carry out a Phase-II/III clinical trial of Covaxin in the age group of 2 to 18 years. The trial will be conducted in 525 healthy volunteers.

Apart from Covaxin, vaccine maker Serum Institute’s Covishield is being used to vaccinate people in the country. Meanwhile, Russia’s Covid-19 vaccine Sputnik V is also available at Apollo Hospital at Hyderabad’s Jubilee Hills and is being administered only to the beneficiaries who are 45 years or older.

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