Human trials of Covaxin — India’s first vaccine candidate against Covid-19 infection — will start at the All India Institute of Medical Sciences (AIIMS), Delhi, with the premier institution getting approval from the ethics committee to begin the process of enrolling participants.
A total of 100 participants will be recruited by the institute, with the trials being carried out on 375 participants in the first phase.
So far, AIIMS Patna and Post-Graduate Institute of Medical Sciences in Rohtak have begun clinical trials of the vaccine candidates.
“We are planning to start the process at Delhi by Monday and will place an advertisement in the newspaper for recruitment of healthy volunteers for the study. Since ours is an autonomous institute, we were waiting for the requisite approval from the ethics committee,” Dr Sanjay Rai, Principal Investigator Covid-19 Vaccine trial at AIIMS, told The Sunday Express.
Those between 18 and 55 years of age, with no heart, kidney, liver, or lung illness, and no uncontrolled diabetes or hypertension, will be eligible to participate in the study.
The department has launched a dedicated email ID and phone number for the project. Interested participants can register themselves by sending a message or making a call via Whatsapp to the number shared by the medical institute.
So far, 15 people have expressed interest with the department.
“We had asked them to wait since we hadn’t received permission from the ethics committee. They were told that the department will contact them once the approval is received. This was the standard answer given to all the people who had expressed their willingness to participate in the trial,” said Dr Rai.
The institute has not received the stock of the vaccine yet. In the first few days, the department plans to enroll five participants on a daily basis and will later expand it to 10-15 per day.
“We were waiting for the ethics committee approval before getting the stock of the vaccine. We will now start the process from Monday. The recruitment process might get over in the next 10-15 days,” he added.
The vaccine has been developed by the Hyderabad-based pharmaceutical company Bharat Biotech in collaboration with National Institute of Virology (NIV) and the Indian Council of Medical Research (ICMR).
The Drug Controller General of India (DCGI) earlier approved the company to initiate phase I and II human clinical trials.
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