New Delhi: An expert panel of Drugs Controller General of India (DCGI) has permitted Bharat Biotech to administer a third dose of its COVID-19 vaccine Covaxin to a select group of volunteers in its clinical trials, PTI reported quoting sources.
“The firm (Bharat Biotech) presented amendments in the approved Phase 2 clinical trial protocol for administration of booster dose after six months after second dose. After detailed deliberation, the committee recommended that the firm should conduct the booster dose study only in 6 mcg cohort and also should follow up the subjects at least for six months after the third dose,” the subject expert committee (SEC) of DCGI said.
Bharat Biotech has been asked to present details of the primary and secondary objectives, and all the assessments to be carried out.
“Accordingly, the firm should submit the revised clinical trial protocol for evaluation,” the SEC said in the meeting, where Bharat Biotech presented amendments in the approved Phase 3 clinical trial protocol for unblinding of subjects on placebo and addition of another cohort in Brazil which the SEC recommended.
“After detailed deliberation, the committee recommended that the firm may unblind the participants of age group of more than 45 years and offer to administer the vaccine free of cost as and when they become eligible for the vaccine in the national programme,” the SEC said.
The SEC also recommended that the firm should submit a detailed revised clinical trial protocol for inclusion of cohorts from Brazil, along with revised statistical calculation for assessing the vaccine’s efficacy.
