The Drugs Controller General of India (DCGI) has permitted Bharat Biotech to give a third dose of Covaxin to a few volunteers in its clinical trials of the Covid-19 vaccine, sources said.
Bharat Biotech presented amendments to the subject expert committee of the DCGI in the approved Phase 2 clinical trials protocol for administration of booster dose six months after second dose.
The SEC said after a 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.
Further the Bharat Biotech was asked to present the details of the primary and secondary objectives and various assessments to be carried out in the subjects.
