Home · National News · World News · Viral News · Indian Economics · Science & Technology · Money Matters · Education and Jobs. ‎Money Matters · ‎Uttarakhand News · ‎Defence News · ‎Foodies Circle Of IndiaDGCI approved for third dose of CovaxinDoonited News
Breaking News

DGCI approved for third dose of Covaxin

DGCI approved for third dose of Covaxin
Want create site? Find Free WordPress Themes and plugins.

The expert panel of India’s drug regulator, DCGI, has permitted Bharat Biotech to give the third dose of Covaxin to a few volunteers in its clinical trials of the COVID-19 vaccine, sources said. Bharat Biotech presented amendments to the subject expert committee of the Drugs Controller General of India (DCGI) in the approved Phase 2 clinical trial protocol for administration of booster dose six months after the second dose.

“The firm presented amendments in the approved Phase 2 clinical trial protocol for administration of booster dose after six months after the second dose.

After detailed deliberation, the committee recommended that the firm should conduct the booster dose study only in 6 mcg cohort and also should follow up the subjects at least for six months after the third dose,” the SEC said.

Read Also  देहरादून: 6 क्षेत्रों को कन्टेंनमेंट जोन घोषित किया

Further, Bharat Biotech was asked to present the details of the primary and secondary objectives and various assessments to be carried out in the subjects. “Accordingly, the firm (Bharat Biotech) should submit the revised clinical trial protocol for evaluation,” the SEC said in the meeting that took place on March 23.

In the meeting, Bharat Biotech presented amendments in the approved Phase 3 clinical trial protocol for unblinding of subjects on placebo and addition of another cohort in Brazil which the SEC recommended.

“After detailed deliberation, the committee recommended that the firm may unblind the participants of the age group of more than 45 years and offer to administer the vaccine free of cost as and when they become eligible for the vaccine in the national program,” the SEC said.

Read Also  COVID-19: 53,000, 251 deaths reported in last 24 hours in India

Further, the SEC recommended that the firm should submit a detailed revised clinical trial protocol for the inclusion of cohorts from Brazil along with the revised statistical calculation for assessing the efficacy of the vaccine. 

Did you find apk for android? You can find new Free Android Games and apps.

Related posts

doonited mast
%d bloggers like this:
Skip to toolbar