“The firm 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 SEC said.
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.
“Accordingly, firm (Bharat Biotech) should submit the revised clinical trial protocol for evaluation,” the SEC said in the meeting that took place on March 23.
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 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 program,” the SEC said.
Further, the SEC recommended that the firm should submit a detailed revised clinical trial protocol for inclusion of cohorts from Brazil along with the revised statistical calculation for assessing the efficacy of the vaccine.