Phase 3 Trials For Covaxin Reaches Final Stage As Investigators At NIMS Give Booster Dose To Participating Volunteers

The phase 3 clinical trials for Covaxin, the COVID-19 vaccine being developed by the Hyderabad-based Bharat Biotech, have almost reached to the concluding stage, as the investigators of the vaccine at Nizam’s Institute of Medical Sciences (NIMS) have injected booster dose to as many as 100 volunteers out of 1,300 volunteers who had been administered with the first dose during the first week of December this month.According to Prabhakar Reddy, Principal Investigator of clinical trials at NIMS, with the success of first and second phase clinical trials, recently the Drug Controller General of India has given its nod for carrying forward the third phase clinical trials. As part of which the NIMS authorities had administered first dose to 1,300 volunteers after which a second dose is being given to 100 volunteers after a wait of 28 days after the first dose.“Based on the report of first and second phase clinical trials submitted to the DCGI, we have got approval from the highest drug control body in the country to carry on the 3rd phase clinical trials for Covaxin. Initially, we administered first dose to 1,300 subjects who had volunteered for the 3rd phase clinical trials and now after 28 days, we have given a booster dose to about 100 subjects. The results have been positive and very soon we will conclude completing the 3rd phase clinical trials,” informed the principal investigator.Overall, at NIMS as many as 1,400 volunteers have already undergone clinical trials in phase 1, phase 2 and phase 3. So far, the reports of all these volunteers have shown remarkable results and very soon with the investigators are expected to conclude phase 3 clinical trials for safety, efficacy and its effectiveness in inhibiting the COVID-19 disease on a large scale.In fact, the phase 1 human clinical trials started on July 20 this year, during which 50 volunteers were given 3 ml of Covaxin, after two weeks of study for safety, another 6 ml booster dose of the vaccine was administered in the second level to 34 subjects. During the two weeks of study on the patients’ condition, the investigators found that all the subjects were safe and stable.After which another 16 subjects were given 6ml booster dose after two more weeks of study of the first batch. During first phase 1, all volunteers are safe and stable, after all tests are conducted and satisfied with the health parameters of the subjects.The second phase clinical trials were taken up during the first week of October this year. As part of which 100-300 volunteers were administered first dose and booster dose and detailed clinical and medical tests were conducted on the subjects. “During second phase clinical trials we could successfully achieve the expected results as the volunteers who received the vaccine showed adequate antibodies presence and improved their immunity power tremendously to fight the virus. Now, during our 3rd phase clinical trials, all the subjects who have been given initial and booster disease are undergoing intense medical tests and are under regular observation. Very soon we are hoping to conclude the clinical trials as all the volunteers undergoing the clinical trials have shown remarkable results as expected,” said a member of special investigating team at NIMS

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