According to sources, the expert panel of India’s drug regulator, DCGI, has given its permission to Bharat Biotech for the trial of the third dose of Covid-19 vaccine to a few volunteers in its clinical trials of the Covid-19 vaccine
Further, Bharat Biotech was asked to present the details of the primary and secondary objectives and various assessments to be carried out in the subjects.
“The firm presented amendments in the approved Phase 2 clinical trial protocol for administration of booster dose after six months after the second dose. After detailed deliberation, the committee recommended that the firm should conduct the booster dose study only in a 6 mcg cohort and also should follow up the subjects at least for six months after the third dose,” the SEC said.
The SEC said in the meeting on March 23 that “Accordingly, the firm (Bharat Biotech) should submit the revised clinical trial protocol for evaluation”. In the meeting, 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 groups 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 program,” the SEC said.
Further, the SEC recommended that the firm should submit a detailed revised clinical trial protocol for the inclusion of cohorts from Brazil along with the revised statistical calculation for assessing the efficacy of the vaccine.