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Covaxin phase three trial to start next month

With the first two phases not throwing up any adverse effects, the phase three trial of Bharat Biotech’s COVID-19 vaccine, Covaxin, is likely to start next month. Phase two of the trial that would go on for about six months is ongoing, said researchers, adding that the next phase would start simultaneously.

Covaxin phase three trial to start next month


Dr Sathyajit Mohapatra, who is leading the trials at SRM Medical College and Research Centre, said the vaccine has been found to be safe in the phase one and phase two trials so far, with no major adverse effects being noticed among the participants from the State.

“Bharat Biotech and Indian Council of Medical Research (ICMR) will analyse the results and present it to Drug Controller General of India (DCGI). About 1,500-2,000 volunteers will be enrolled for phase three trial – adequate number of volunteers have come forward to take part in the trial. Across the country, about 30,000 volunteers will be enrolled,” said Dr Mohapatra.

After sharing the results of the first two phases with the DCGI, the data on the safety and immunogenicity of the vaccine so far would published in about two weeks, sources said. ICMR and Bharat Biotech would submit data from all the research sites across the country.

Dr Mohapatra added that despite attracting a sizeable number of volunteers for the trials, around 40 per cent of them had antibodies against coronavirus and could not thus be included in the trials. The trial required healthy individuals who do not have exposure to the virus. “However, we found out that about 40 per cent of the volunteers were already positive for antibodies and could not be enrolled,” he said.

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