Drugs Controller General of India allows clinical trials for third dose of Covaxin

Bharat Biotech presented amendments to the DCGI in the approved Phase 2 clinical trial protocol

Bharat Biotech, the homegrown vaccine developer, has got permission from the expert panel of India’s drug regulator to conduct clinical trials for a third booster dose of Covaxin on a few of its volunteers.

The expert panel of the Drug Controller General of India (DCGI) gave its nod for the booster dose to be administered on volunteers, six months after the 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) said.

The vaccine maker was also asked to present the details of the primary and secondary objectives and various assessments to be carried out in the subjects.

“Accordingly, the firm should submit the revised clinical trial protocol for evaluation,” the committee said.

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At the vaccine maker’s request, the committee recommended that the firm may unblind the participants of the 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

Bharat Biotech had presented amendments in the approved Phase 3 clinical trial protocol for unblinding of subjects on placebo and addition of another cohort in Brazil.

The committee also asked Bharat Biotech to 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.

Read more: Brazil regulator says Bharat Biotech's Covaxin does not meet factory standards

Sputnik delayed

Meanwhile, the SEC has sought additional data and information from Dr Reddy’s Laboratories (DRL), which has sought emergency use authorisation for the Russian-made Sputnik V vaccine.

The committee asked DRL to present data pertaining to all immunogenicity parameters, unblinded data of serious adverse events and RT-PCR positive cases, along with causality analysis reported till the date for further examination.