Covaxin trials begin for children at AIIMS Patna

Earlier in the week, NITI Aayog's Member Health, Dr V.K. Paul said: "Covaxin has been approved by the Drugs Controller General of India (DCGI) for Phase 2 and 2 clinical trials in the age group of two to 18 years. I have been told that trials will...

The All India Institute of Medical Sciences (AIIMS) in Patna has begun clinical trials of Bharat Biotech's Covaxin for children aged between 2 to 18 years, Prasar Bharati has reported.

According to a TOI report, AIIMS-Patna superintendent Dr CM Singh had said they are targeting to include between 70 and 80 children in the trial phase that began with the registration of a 13-year-old Patna boy, on Friday.

Last month, NITI Aayog's Member Health, Dr V.K. Paul said: "Covaxin has been approved by the Drugs Controller General of India (DCGI) for Phase 2 and 2 clinical trials in the age group of two to 18 years. I have been told that trials will begin in the next 10-12 days."


Bharat Biotech received the DCGI approval to conduct clinical trials of Covaxin in children on May 11, following the Central Drugs Standard Control Organisation's subject expert committee's recommendation, under certain conditions.

Approval of clinical trials of vaccine efficacy among children came amid reports from the US and Canada allowing Pfizer-BioNTech for the 12-15 age groups.

The clinical trials are expected to be conducted among over 500 participants at various hospitals across the country.
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AIIMS Director, Dr Randeep Guleria had said that the need of the hour is some quick data and risk-benefit analysis of the vaccine's use in children.
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