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Government panel allows Bharat Biotech to test Covaxin booster shot
The booster shot is proposed to be given six months after the second dose, and the subject expert committee has approved to test it the phase 2 trial stages
The Central Drugs Standard Control Organisation Subject Expert Committee (SEC) has allowed Bharat Biotech to test results for administering a third dose of its anti Coronavirus disease (Covid-19) vaccine, Covaxin, which the company feels will provide better efficacy against the viral infection.
The booster shot is proposed to be given six months after the second dose, and the subject expert committee has approved to test it the phase II trial stages.
“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,” said the subject experts in their recommendation in the 148th meeting held on March 23, 2021.
The 6mcg dose has been chosen because it showed better immune response. Covaxin is a two-dose whole virion inactivated vaccine that is to be given 28 days apart, as per the current recommendations.
“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,” said the subject experts, according to the minutes of the meeting that were made public by CDSCO.
The phase II trial tests the immune response against the drug or a vaccine, and the phase III trial is to check for efficacy of the product being tested. The initial results of phase III trials of Covaxin that were submitted to the national drugs regulator last month has shown nearly 81% efficacy against the viral disease.
Bharat Biotech has co-developed Covaxin along with the Indian Council of Medical Research (ICMR).
Covaxin is one of the two vaccines approved for restricted use in India currently. The other one being Oxford-AstraZeneca vaccine that is being locally manufactured by Serum Institue of India under the brand name Covishield.
