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Covaxin's Clinical Trials On Children Aged Between 2 To 18 Begins At AIIMS Patna
Bharat Biotech’s COVAXIN, India’s first indigenous vaccine against coronavirus. (Swarajya Magazine)
Covaxin trials on children aged between two and 18 years have begun at All India Institute of Medical Sciences (AIIMS) Patna, Times of India has reported.
The registration for the same was opened last week.
The development comes days after India's apex drugs regulator granted permission for conducting the phase II/III clinical trials on children on 11 May, following the Central Drugs Standard Control Organisation's subject expert committee's recommendation, under certain conditions.
Addressing the Union Health Ministry press conference, 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 3 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."
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. 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.
The Ahmedabad-based Zydus Cadila has also found its Covid-19 vaccine safe for children in clinical trials.
“We have not seen anything to worry about when it comes to safety for the whole trial and for children also. Our trial is already approved for children between 12-18 years. We will have the data very soon and then we will also apply for its use in younger age groups. So far, on the safety front we have not seen any concern with administering these doses,” company’s managing director Sharvil Patel had said.
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