Bharat Biotech's Covaxin booster dose gets nod for trial, to be administered after second shot

The Subject Expert Committee (SEC)'s approval for the trial allows Bharat Biotech to administer an additional booster dose to volunteers to test Covaxin's ability to prompt an immune response that may last a few years.

A Drugs Controller General of India (DCGI) expert committee has allowed Bharat Biotech to administer a third dose of its Covaxin COVID-19 vaccine to some volunteers in its ongoing clinical trials.

The Subject Expert Committee (SEC)'s approval would allow the biotechnology company to administer an additional booster dose to volunteers to test the ability of Covaxin to prompt an immune response that could last a few years, the report suggested.

The expert panel recommended that the booster dose study be conducted in phase-2 clinical trial participants who received two shots of Covaxin containing 6mcg of the deactivated SARS-CoV-2 virus.

As part of the trail, the third dose is to be given six months after the participants receive their second shot – which had already been administered to them between September and October 2020.

According to reports, Bharat Biotech is required to present details of the primary and secondary objectives and assessments to be carried out on the subjects, and submit a revised clinical trial protocol for evaluation.

Participants from phase-2 would not be further divided into two groups. One of the groups would be given the third booster shot. Both groups would be studied to check how long Covaxin's protection stays.

The trial is also likely to help the company understand whether the third dose helps build stronger Memory T Cells in the body.