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Bharat Biotech has been permitted to do a booster dose study for its Covid-19 vaccine, Covaxin, by the Central Drugs Standard Control Organisation’s Subject Expert Committee (SEC) to provide better efficacy.
The Hyderabad-based vaccine manufacturer had sought amendments to the approved Phase II clinical trial protocol involving administration of a booster dose six months after the second dose.
The expert panel took up the matter at its meeting on March 23-24. “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,” said the subject experts in their recommendations.
Covaxin is a two-dose whole virion inactivated vaccine that is to be given 28 days apart, as per the current recommendations.
The vaccine maker should 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 minutes of the meeting said.
Covaxin is now being administered by the government and private hospitals. It has showed 81 per cent efficacy in interim phase III clinical trials.
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