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Covid-19: Government Expert Panel Allows Clinical Trials for Third Dose of Covaxin | India News

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NEW DELHI: India’s drug regulator DCGI’s expert panel has allowed Bharat Biotech to administer a third dose of Covaxin to a few volunteers in its clinical trials of the Covid-19 vaccine, sources said.
Bharat Biotech submitted amendments to the Comptroller General of Drugs of India (DCGI) subject matter expert committee on the approved phase 2 clinical trial protocol for the administration of the booster dose six months after the second dose.
“The company submitted amendments to the approved phase 2 clinical trial protocol for the administration of the booster dose after six months after the second dose. After detailed deliberation, the committee recommended that the company conduct the study of booster doses only in a 6 mcg cohort and should also continue to elevate subjects for at least six months after the third dose, “the SEC said.
Additionally, Bharat Biotech was asked to present the details of the primary and secondary endpoints and the various assessments that would be performed on the subjects.
“Accordingly, the company (Bharat Biotech) should submit the revised clinical trial protocol for evaluation,” the SEC said at the March 23 meeting.
At the meeting, Bharat Biotech presented amendments to the approved phase 3 clinical trial protocol for unmasking subjects in placebo and the addition of another cohort in Brazil recommended by the SEC.
“After detailed deliberation, the committee recommended that the company be able to unmask participants in the age group over 45 and offer to administer the vaccine at no cost when they are eligible for the vaccine in the national program,” the SEC said. .
In addition, the SEC recommended that the company submit a detailed revised clinical trial protocol for the inclusion of cohorts from Brazil along with the revised statistical calculation to evaluate the efficacy of the vaccine.

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