The third phase of the human trial of the indigenous vaccine against COVID-19, COVAXIN, will commence at a personal hospital here soon, a politician said.
The look for an appropriate vaccine for COVID-19 has almost come to the ultimate stage, Dr E Venkata Rao, PI within the COVAXIN human trial and Professor within 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 the country by the Indian Council for Medical Research (ICMR) where the third phase trial would be conducted.
The indigenous vaccine, being developed by ICMR and Bharat Biotech has received the approval of the Central Drugs Standard Control Organisation (CDSCO) for initiating the third phase trial.
After completion of the primary and second phase of the trial with demonstrable safety profile and immunogenicity, the large-scale efficacy trial involving thousands of volunteers has been planned now, Dr Rao said.
Dr Rao, who is that the head of the Preventive and Therapeutic clinical test Unit (PTCTU), said during this phase the regulation and eligibility/ screening criteria would be relaxed and a number of other volunteers who are otherwise apparently healthy would be recruited for the trial.
Like the previous phases, half the volunteers would receive placebo and therefore the remaining half would be administered COVAXIN during this phase. Even health care workers would be recruited for the trial. The volunteers would be followed up over a substantial period of your time to seem at the efficacy of the vaccine in preventing the event of the Corona disease, he said.
