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The Drug Controller General of India (DCGI) on Thursday allowed Bharat Biotech to conduct a clinical trial of its Covid-19 vaccine covaxin on children between 2 and 18 years of age. The Hyderabad-based firm said that Bharat Biotech will test it on 525 healthy volunteers. This will be its second and third phase trial.
This decision has been taken after the Subject Expert Committee recommended permission in favor of Bharat Biotech. The government said that permission has been given after careful scrutiny.
Drugs Controller General of India (DCGI) approves Phase II / III clinical trial of COVAXIN in the age group of 2 to 18 years. Bharat Biotech to conduct trials in 525 healthy volunteers: pic.twitter.com/ibxAW97bAc: ANI (@ANI) May 13, 2021
The government said that during the trial, the vaccine would be administered via muscle in two doses at an interval of 28 days. As a rapid regulatory response, the proposal was discussed on 11.05.2021 in the Subject Expert Committee (SEC) (Covid-19).
It further stated that after detailed deliberations, the committee recommended allowing the proposed second and third phase clinical trials with certain conditions.
News Source: TimesOfIndia
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