Preparations are underway at the Institute of Medical Sciences and SUM Hospital here for the commencement of the second phase of the human clinical trial of ‘Covaxin’, India’s indigenous COVID-19 vaccine.
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“The Phase I of the trial is still continuing as we are planning for the start of the Phase II trial shortly,” Dr. E. Venkata Rao, Principal Investigator of the trial at IMS and SUM Hospital, faculty of medical sciences of the SOA Deemed to be University said. The blood samples collected from the volunteers who received the vaccine were to ascertain how effective the vaccine was in terms of the level of antibodies developed, Dr. Rao said adding that there had been ‘no side effects’ in the first phase trial.
The IMS and SUM Hospital is one of the 12 medical centres in India chosen by the Indian Council for Medical Research (ICMR) for conducting human trial of the vaccine developed by Hyderabad-based Bharat Biotech. “Two doses of the vaccine were administered to each volunteer after they were selected through a screening process conducted over a period of three to seven days prior to vaccination.
The first dose was administered on Day Zero while the blood sample was collected. The second dose was given on Day 14 and the blood sample was also collected,” Dr. Rao said. Blood samples of the volunteers will also be collected on different days (28, 42, 104, 194 day) for estimating the duration of protection subsequently, he added.