COVAXIN receives a yes to conduct Phase 2/3 clinical trials on children: NITI Aayog

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

Dr-VK-Paul-Member-of-NITI-Aayog covid-vaccine bharat-biotech

Dr VK Paul, Member, NITI Aayog said that the Drugs Controller General of India (DCGI) has approved the Phase 2-3 clinical trials of Covid vaccine - COVAXIN on children aged 2 to 18 years. The trials are expected to commence in the coming 10 to 12 days.

"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 will be the first time in India that a Covid-19 vaccine will be tested on children. In the trials, two shots of the Covid vaccine injection will be given on day 0 and day 28.  The trial will be carried on 525 healthy volunteers.

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 permitted the Hyderabad-based Bharat Biotech to carry out Phase II/III clinical trials of Covaxin in the age group 2 to 18 years.

Also Read: Ludhiana: COVID rural awareness drive launched

Apart from Covaxin, Serum Institute's Covishield is another vaccine being used to inoculate people in the country. Meanwhile, Russia's Covid-19 vaccine Sputnik V has arrived in India and is also available at Apollo Hospital at Hyderabad. 

Those beneficiaries who are 45 years or older are being administered with the Sputnik V vaccine. 

Reports propose that RDIF will soon start its single-dose vaccine Sputnik V Light in India. 

"We hope for the introduction of Sputnik V Light in India soon," RDIF CEO Kirill Dmitriev had said.

Also Read: Kejriwal announces a series of financial welfare schemes for children orphaned by Covid 2nd wave

The Union Health Ministry earlier Monday said that more than 23,000 adverse events have been reported following Covishield and Covaxin vaccination shots and of these among 700 cases were reported to be serious.

 

 

 



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