Bharat Biotech gets nod to conduct phase II/III trials for 2-18 yr olds

India's drug regulator has accepted the recommendation of the Subject Expert Committee and given a nod to Hyderabad-based Bharat Biotech to conduct phase II/III clinical trial of COVID-19 vaccine Covaxin for children aged 2-18 years. The trails will begin in the next 10-12 days.

By Newsmeter Network  Published on  18 May 2021 4:09 PM GMT
Bharat Biotech gets nod to conduct phase II/III trials for 2-18 yr olds

Hyderabad: India's drug regulator has accepted the recommendation of the Subject Expert Committee and given a nod to Hyderabad-based Bharat Biotech to conduct phase II/III clinical trial of COVID-19 vaccine Covaxin for children aged 2-18 years. The trails will begin in the next 10-12 days.

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

The proposal was deliberated during a meeting of the Subject Expert Committee (SEC) on 11 May, the health ministry said last week. On 13 May, India had given clearance to conduct trials for the 2-18 age group.

"COVAXIN has been approved by the Drugs Controller General of India (DCGI) for phase II/III clinical trials in the age group of 2 to 18 years. I have been told that trials will begin in the next 10-12 days," said Dr. V.K Paul, a member of the NITI Aayog.

The trial will involve 525 subjects at various sites. They will receive two shots of the vaccine 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.

Most nations are yet to approve any vaccine for children. Last week, the US authorized Pfizer and BioNTech's COVID-19 vaccine for use in children aged between 12 and 15 years. Canada has also approved the use of the Pfizer-BioNTech vaccine in children aged 12 years and up.

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 beneficiaries who are 45 years or older.


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