Govt’s expert panel allows clinical trials for third dose of Covaxin3Photo© timesofindia.indiatimes.com

Govt’s expert panel allows clinical trials for third dose of Covaxin

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The expert panel of India's drug regulator, 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 Drugs Controller General of India (DCGI) in the approved Phase 2 clinical trial protocol for administration of booster dose six months after second dose.

"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.