AIIMS Director Randeep Guleria said that in Phase 1, 375 samples will be tested for safety and dose range adjustment.
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The All India Institutes of Medical Sciences (AIIMS) on Monday asserted that the human clinical trial of coronavirus COVID-19 vaccine will be conducted in three phases and on 1125 people, out of the 1800+ volunteers, who registered on the AIIMS website.
AIIMS Ethics Committee on July 18, gave its approval for conducting the human clinical trial of the indigenously developed COVID-19 vaccine candidate Covaxin.
The country`s top drug regulator had recently given a green signal for human clinical trials for COVID-19 vaccine candidate Covaxin, which has been developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV).
AIIMS Director Randeep Guleria on Monday said that in Phase 1, 375 samples will be tested for safety and dose range adjustment. The trial will be done on healthy people aged 18-55 years who have no co-morbidity.
In the second phase, 750 people will be studied between the age group of 12-65 years. The third phase will be the largest group of volunteers. It will be to see how much immunity people have received finally. Speaking on the dosage, Guleria said that two-dose and three formulations are being tried. A dose of three micrograms will be done followed by six micrograms.
The monitoring of the side effects will be done for two hours in the hospital and then up to 28 days in the first phase. A follow up will be done regularly for up to three months. The volunteers will be tested for kidney function and other basic tests before registration. A COVID-19 test will also be done first and they should be healthy.
He added that once the vaccine is out, priority will be given to high-risk groups and health care workers. The director quoted a Singapore study where it was found that people who did not have COVID-19 already have some amount of immunity against the coronavirus.
“So it is assumed that in Southeast Asia, we have certain immunity against the virus. Which means we may have had some amount of coronavirus exposure in the past. That’s why we have better immunity than the western world,” he said.
On community transmission, the AIIMS director said that it is only at the local level. “No community transmission has started at the national level. Local hotspots need to be controlled. Several states don’t have many cases so we can’t say there is community transmission.”
News Credit Zee News