New Delhi: India’s top drug regulator and Subject Expert Committee (SEC), Central Drugs Standard Control Organisation has allowed Bharat Biotech to run a third dose of its Covid-19 vaccine, Covaxin, on clinical trial, which the company feels will provide better efficacy against the viral infection.
The approval comes as a result of the Hyderabad-based vaccine maker’s proposal to use an additional booster dose, in order to test the ability of Covaxin to prompt an immune response that could last a few years.
The booster shot is proposed to be given six months after the second dose, and the expert panel has approved to test it in the phase II trial stages to some of the volunteers in its ongoing clinical trials of the Covid vaccine.
“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.
As per current recommendations, 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.
“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, based on the discussion during the meet that were made public by CDSCO.
To note, phase II trial tests the immune response against the drug or a vaccine, while 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 showed nearly 81% efficacy against the viral disease.
Bharat Biotech has co-developed Covaxin along with the Indian Council of Medical Research (ICMR). Covaxin is being one of the two vaccines approved for restricted use in India currently, the other one is Oxford-AstraZeneca vaccine that is being locally manufactured by Serum Institue of India under the brand name ‘Covishield’.