Covaxin Phase II/III Clinical Trial For 2-18 Age Group Cleared By DCGI
Mumbai: The Drugs Controller General of India (DCGI) has approved Phase II/III clinical trial of Covaxin in the age group 2 to 18 years. Bharat Biotech will conduct the trials on 525 healthy volunteers, the Hyderabad-based firm said.
The decision comes after the recommendation of permission in favour of Bharat Biotech by the Subject Expert Committee. Permission is given after “careful scrutiny”, the government said.
The government said that during the trial, the vaccine would be vaccinated through the muscle in two doses at intervals of 28 days. The test will be conducted at AIIMS Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences, Nagpur.
“As a swift regulatory response, the proposal was deliberately given to the Subject Expert Committee (SEC) (COVID-19) on 11.05.2021. After detailed deliberations, the committee proposed the Phase II / III clinical It was recommended to allow for certain conditions for testing., “It said.
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Bharat Biotech, which developed Covaxin in collaboration with the Indian Council of Medical Research, submitted a proposal for tests conducted on children earlier this year. The proposal was considered at a subject expert committee meeting in February as Bharat Biotech was asked to submit a revised clinical trial protocol.
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