Officials have confirmed that the preparations are underway for the initiation of phase two of the human clinical trial of ‘Covaxin’ which is Indigenous coronavirus vaccine.
“The Phase I of the trial is continuing as we are planning for the start of the Phase II trial shortly,” Dr E Venkata Rao, Principal Investigator of the trial at Institute of Medical Sciences and SUM Hospital, faculty of medical sciences, said.
The blood samples had been collected from the volunteers who received the first dosage in order to ascertain the effectiveness of the vaccine and especially in terms of the antibodies developed informed by Dr Rao. He further added that there had been no cases of side effects in the phase one human trial of the vaccine.
“Two doses of the vaccine were administered to each volunteer after they were selected through a screening process conducted over three to seven days before 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.
The Indian Council for Medical Research (ICMR) has chosen the IMS and SUM hospital for conducting the human trial of the vaccine developed by the Hyderabad based Bharat Biotech. The IMS and SUM hospital is one of the 12 medical centres in the country chosen by the ICMR for the vaccine trial.
Dr Rao further added that the blood samples of the volunteers will be collected on different days (28, 42, and 104, 194 days) in order to estimate and analyze the duration of protection in a subsequent manner. He said that there is a lot of enthusiasm among people to be a part of the phase two trial.