Covid vaccine trial in Odisha to begin early next week
BHUBANESWAR: Human trials of the indigenously developed Covid-19 vaccine (BBV152 Covid Vaccine) will begin in IMS and SUM Hospital here early next week. Trials have already started in some of the other designated centres in the country.
“We will inaugurate the preventive and therapeutic vaccine trial centre in the hospital on Monday. All the arrangements are in place. The actual trial will start within a day or two of the inauguration of the centre,” said E Venkat Rao, professor of community medicine and principal investigator of the trial at SUM.
The hospital will display the contact details of the centre on its website, so that prospective volunteers can contact it. The trial centre will record the details of those who volunteer to be part of the trial and get in touch them for further requirements, he said.
After screening, the hospital will select suitable volunteers — healthy adults with no co-morbidities — after physical and laboratory examination based on the ICMR protocol. Once the subjects fulfil the inclusion and exclusion criteria, the trial centre will counsel them about the potential risks and obtain their consent before going ahead with the trial.
The hospital will then work out suitable dates and times for the vaccination, Rao said. Those getting the vaccine will have to stay in the trial centre for around two hours for observation to rule out any possible complications. “Some volunteers have already contacted the institute but we can’t disclose their numbers and other details at this stage,” Rao said.
The selected volunteers will get the vaccine in two doses with a 14-days gap in between. While some people will get the BBV152 Covid Vaccine or the test vaccine, others will get a control vaccine (an existing vaccine) as part of the experiment.
This is the first indigenous vaccine developed by India and is derived from a strain of the SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune. The ICMR and Bharat Biotech are jointly working on the preclinical and clinical development of this vaccine.
The SUM, a 1,600-bed teaching hospital, is among 13 medical institutes in the country, and the only one from Odisha, identified by the ICMR to take up the clinical trial.
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