New Delhi: Drug regulator Drug Controller General of India (DGCI) has approved Bharat Biotech for the third dose of Covaxin to some volunteers in the clinical trial of Covid-19 Vaccine.
An expert committee of the drug regulator has given the approval to the vaccine maker, quoting sources. Bharat Biotech introduced amendments to the Phase II Clinical Trial Protocol approved by the Subject Expert Committee of DCGI. Under this, the company introduced an amendment for the administration of a booster dose six months after the second dose.
Subject Expert Committee, after considering this proposal in detail, approved the testing of Busser Dose in only 6 MCG Cohort of the company. Apart from this, the committee has also said that after this third dose, which takes six months after the second dose, the company should keep an eye on it for at least six months.
In this case, the committee had asked the company to present details and various assessments of primary and secondary objects which are to be taken. The committee said in a meeting held on 23 March on this issue that Bharat Biotech will have to submit a revised clinical trial protocol so that it can be evaluated. At the meeting, vaccine maker Bharat Biotech introduced a modification to the Phase III Clinical Approved Phase III Clinical Trial Protocol to open (unblind) the subjects on the placebo and include the second Brazilian cohort.
