The Graduate Institute for Education and Medical Research (PGIMER) is one of 17 institutes across the country chosen for the Oxford-Astra Zeneca University of Astra -Covid-19 vaccine trials (Covishield), which is expected to begin until the end of August.
The institute decided to undergo trials after the Indian Comptroller General of Medicines granted approvals to the Serum Institute of India in Pune for Phases 2 and 3 of the Covishield trials.
Dr. Madhu Gupta, Principal Research Fellow of Trials and Professor of Community Medicine and School of Public Health, PGIMER, says the protocol has been finalized and that approval of the trials will be requested through the institute’s ethics committee.
“Things are moving at a very fast pace. The Ethics Committee will now review the protocol because patient protection is the most sensitive priority. You’ll see the drawbacks and benefits, and once they approve it, we’ll find a site, recruit staff, and start the test. I think until the end of this month we’re going to start recruiting Americans for six-month trials,” Dr. Gupta said.
The institute will promote healthy participants over the age of 18 who have not contracted the infection and who are not in contact with any patient who is positive for Covid-19.
“Approximately 2,000 other people will be evaluated and around 1,600 people will be selected. Among them, we hired 250 other people from PGIMER. Recruitment will take up position within the first month and will be a competitive procedure between sites. We’ll see if the participants expand the opposite coverage of the virus,” Dr. Gupta said.
Professor Jagat Ram, director of PGIMER, said: “The effects of the trials will have a great impact. We will develop our capacity, if necessary, to achieve tangible effects. A small organization will be formed to expand modalities and plan with deadlines to meet the desired expectations of the Comptroller General of India and to involve the pandemic in the most productive way we can. »
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