Written byShubham Sharma
The institute on Friday administered a 30-year-old healthy resident from Delhi with the first dose of the shot and is now moving to enroll and test more volunteers.
Here are the details.
"He was screened two days ago and all his health vital parameters were normal. He does not have any co-morbid conditions or any pre-existing illness," said Dr. Sanjay Rai, who works in AIIMS's Community Medicine Department and is the principal investigator of the human trial.
Following the administration, the volunteer tolerated the vaccine well with no problems at all.
"Post-vaccination, the subject was in close observation for two hours," Dr. Rai said, noting that "there was no sudden side-effect observed [but] the subject will be monitored for a week" through telephone calls.
He has been asked to follow his routine and note down health condition changes, if any.
Now, AIIMS plans to continue the study by enrolling and vaccinating more human volunteers with COVAXIN.
"Screening for 22 subjects is ongoing and only about a third of them were found to have normal parameters. More volunteers will be vaccinated tomorrow once their health screening reports come," Dr. Rai said, adding that more than 3,500 people have registered to take part in the trial.
AIIMS Delhi is one of the 12 Indian sites chosen by Indian Council for Medical Research (ICMR) for Phase 1/2 human trials of COVAXIN.
In the ongoing Phase 1, as many as 375 participants have to be enrolled, of which 100 can be from AIIMS, while the second phase will have 750 volunteers.
The goal of the study is to establish the safety and efficacy of the candidate vaccine.
The experimental vaccine, developed by Hyderabad-based Bharat Biotech, has to clear Phase 1, 2, and the final and the largest Phase 3 of human trials to be ready for approval and public use.
ICMR had previously said it aims to make the shot available by August 15, but Bharat Biotech's founder Dr. Krishna Ella believes it is too early to announce a launch date.
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