Covaxin manufacturer 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.
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Clinical trials to test Covaxin vaccine's efficacy in children between two to 18 years of age will begin in 10-12 days, top officials said on Tuesday.
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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 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."
Covaxin manufacturer 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 announcement came amid reports that new variants are also affecting children.
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. Earlier in the day, Congress leader Rahul Gandhi urged the government put in place a vaccine protocol for children.
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