3th April, 2021
The Subject Expert Committee (SEC) of the Indian Controller General of Medicines (DCGI) has allowed Bharat Biotech to conduct a clinical trial for the third dose of covaxin on some volunteers. Covaccine is also being used in vaccination campaigns against the coronavirus.
The SEC has approved Bharat Biotech for the second phase of clinical trials of covaxin. In this, while presenting the revised application, the company sought permission for clinical trial for booster dose. This dose will be given six months after the second dose of Covaxin.
After discussing in detail the application of Bharat Biotech, the committee said that the company should study the booster dose in the amount of six micrograms. Also, the health of the volunteer should be monitored for at least six months after giving the third dose.
In the SEC meeting held on 23 March, Bharat Biotech has also been asked to give detailed information about the objectives of the trial and various assessments to be done in the volunteer. Accordingly, the company will also have to submit a revised clinical trial protocol for evaluation.