Bhubaneswar: The third phase of the human of the indigenous COVID-19 vaccine COVAXIN, will commence at a private hospital here soon, an official said Monday. The search for a suitable vaccine for COVID-19 has almost reached the final stage. This information was shared by Dr E Venkata Rao, Principal Investigator in the COVAXIN human trial and Professor in the department of Community Medicine at the Institute of Medical Sciences and SUM Hospital here said on Sunday.
IMS and SUM Hospital is among the 21 medical institutes selected across India by the Indian Council for Medical Research (ICMR) where the third phase trial would be conducted.
The indigenous vaccine is being developed by ICMR and Bharat Biotech. The vaccine has received the approval of the Central Drugs Standard Control Organisation (CDSCO) for initiating the third phase trial.
Also read: Human clinical trial of COVID-19 vaccine ‘Covaxin’ begins at Bhubaneswar hospital
The first and second phase of the trials has been completed with demonstrable safety profile and immunogenicity, Dr Rao said. Now the large-scale efficacy trial involving thousands of volunteers has been planned now, Dr Rao said.
He informed that during this phase the age limit and eligibility/ screening criteria would be relaxed. Several volunteers who are otherwise apparently healthy would be recruited for the trial.
Like the previous phases, half of the volunteers would receive placebo. The remaining half would be administered COVAXIN in this phase. Even healthcare workers would be recruited for the trial. The volunteers would be followed up over a considerable period of time to look at the efficacy of the vaccine in preventing the development of the Corona disease, Dr Rao informed.
Dr Rao also said there had been a huge response and enthusiasm among people. They have come forward to offer themselves to be volunteers for the trial. He said persons above 18 years will be taken for the human trial.
The interested volunteers for the project could enroll themselves for the trial by registering online at www.ptctu.soa.ac under the section register for clinical trials, informed Dr Rao.
