Bharat Biotech’s Covaxin allowed to test booster shot
New Delhi, Apr 02: Bharat Biotech has been allowed to test the Covaxin booster shot by the Central Drugs Standard Control Organisation Subject Expert Committee.
Administering a third dose of the vaccine against coronavirus would provide better efficacy against the infection, the company feels.
The booster shot is to be given six months after the second dose. The subject expert committee has approved to test it when the phase 2 trials begin. The subject experts said in its recommendation in the 148th meeting held on March 23 that the firm presented amendments in the approved Phase II clinical trial protocol for administration of booster dose after 6 months after second dose. After detailed deliberation, the committee recommended that the firm should conduct the booster dose study only in 6mcg cohort and also should follow up the subjects at least for 6 months after the third dose.
"Further, the firm 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 subject experts also said.