The Covaxin trials will take place in 525 subjects at various sites
New Delhi:
The Phase II/III clinical trials of Covaxin, indigenous COVID-19 vaccine, in the 2-18-year-olds will begin in the next 10-12 days, senior NITI Aayog member VK Paul announced Tuesday.
The proposal was deliberated in Subject Expert Committee (SEC) (COVID-19) on May 11, the Health Ministry said last week. On May 13, India gave clearance for the trials in 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 VK Paul, Member-Health, NITI Aayog.
The trial will take place in 525 subjects at various sites.
Covaxin, along with Covishield, is being used in adults in India’s ongoing COVID-19 vaccination drive.
Most nations are yet to approve any vaccine for the use of children. Last week, the US authorised Pfizer and BioNTech’s COVID-19 vaccine for use in children aged between 12 years and 15 years. Canada has also approved the use of the Pfizer-BioNTech vaccine in children aged 12 years and up.
Earlier today, Delhi Chief Minister Arvind Kejriwal flagged a new Covid variant detected in Singapore, which he said, is proving dangerous for children. Arguing that it can “come as a third wave” in India, he appealed to the centre to take immediate measures.
“The new form of Corona that came to Singapore is being said to be extremely dangerous for children, in India it may come as a third wave. My appeal to the central government: 1. Air services with Singapore to be cancelled with immediate effect 2. Priority on vaccine options should be worked out for children too,” he said in a Hindi tweet.