Covaxin | Bharat Biotech
Bharat Biotech to start Covaxin trials in 2-18 age grp in next 10-12 days: Niti Aayog member
New Delhi/IBNS: Bharat Biotech will launch the phase II and III clinical trials for Covaxin in children between the ages of 2 to 18 years in the next 10-12 days, Dr VK Paul, member (health) of Niti Aayog, said on Tuesday.
"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," Paul said during a press conference, reported Hindustan Times.
On May 11, Drugs Controller General of India's (DCGI) gave its nod to conduct clinical trials in children.
DGCI gave the permission based on the recommendations by the subject expert committee (SEC) of the Central Drugs Standard Control Organisation’s (CDSCO), which signalled the trial subject to certain conditions, the report said.
In February last, Bharat Biotech had approached the DGCI seeking permission for conducting clinical trials in children in the 5-18 age group.
However, the central drug regulator had rejected the proposal and asked the firm to come up with data showing the vaccine's efficacy in adults first.
The US and Canada have already approved the Pfizer-BioNTech shots for ages 12-15 and started vaccinating them from May 14.
Canada,too, had approved the Pfizer jabs for this age group on May 5.
Meanwhile, the European Medical Agency is also measuring the efficacy of the use of Pfizer vaccines in beneficiaries below 18 years of age.
The clinical trials in India are expected to be conducted in 525 participants at multiple hospitals, the HT report said.
AIIMS chief Dr Randeep Guleria had stated the need for quick data and risk-benefit analysis of the Covid-19 vaccine in children.
Experts across the world have been appealing to the governments across the world to vaccinate children for the schools to reopen safely.
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