The committee after detailed deliberation recommended for grant of permission to conduct the proposed Phase II-III clinical trial to certain conditions.
(Image: Twitter@SerumInstIndia and PTI)
The Drugs Controller General of India (DCGI) has now given permission to conduct the Phase II-III clinical trial of Covaxin to two-to-18-years-old age group.
The Union Health Ministry stated that the trial will be conducted on 525 healthy volunteers. The vaccine will be given by intramuscular route in two doses at day 0 and day 28.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Tuesday deliberated upon Hyderabad-based Bharat Biotech’s application seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity, and immunogenicity of Covaxin jabs in children aged 2 to 18 years.
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The committee after detailed deliberation recommended for grant of permission to conduct the proposed Phase II-III clinical trial to certain conditions.
The vaccine has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). Currently, the vaccine is being used in adults in India’s ongoing COVID-19 vaccination drive.
India recorded 3,62,727 new coronavirus cases in the last 24 hours taking the overall caseload to 2,37,03,665, according to data from the Union Health Ministry.
The country’s active COVID-19 cases stand at 37,10,525.
With 4,120 deaths in the last 24 hours, the total death toll stands at 2,58,317.
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