The desire to help, nationalism, and a sense of wanting to be part of history are some of the reasons that drive volunteers to participate in vaccine trials. Being part of a vaccine trial for a disease as little-known and virulent as Covid-19 can be both an act of courage and a harrowing experience, especially since volunteers are given a weakened version of a pathogen. But that hasn’t stopped people from reaching out to participate. Doctors in Delhi, Chennai and Patna, where trials are ongoing, say this is the first time they have seen such an overwhelming response to participation in clinical trials.
Dr Sanjay Rai, Professor (Community Medicine), at AIIMS Delhi, says they received over 4,500 applications for Phase I. “I have never seen this kind of reaction. Of course, social media and news channels helped us reach more people, “says Dr. Rai, who is part of the team conducting the covaxin trials. They selected about 100 people for Phase I. For the Phase II too, the response was good. To date, our inbox had about 800 emails, “says Dr. Rai, regarding Phase II, for which they ultimately selected between 90 and 100 people. Among the reasons most people have come forward, Dr. Rai says, are “patriotism and the desire to get a vaccine quickly.”
These were precisely the reasons why a businessman in his 30s participated in the Phase II trials in Delhi. “I went against the wishes of my family. I understand your point of view, but I had to do it for my country, my people. How long can we live in fear? ”Asks the Delhi resident, who does not want to be identified. You are now waiting to receive the second dose.
In Chennai, Prashadh also prevailed over his family’s concerns and decided to volunteer at the SRM Institute of Science and Technology, one of more than 10 institutes across the country selected by the Indian Council for Medical Research (ICMR) for trials. of the vaccine. developed by Bharat Biotech.
Prashadh called SRM and signed in over the phone, but it was only when he got into his car on the morning of September 8 to drive from his home to the institute that the enormity of what he had signed hit him. “I had read enough about the trials and research required to create a vaccine. He was confident and excited, but also anxious. During that trip, some questions remained in my head: What if I have asymptomatic covid? What happens if I contract the virus while walking down the hospital corridor? “
At SRM, Prashadh had to fill out a form with details like his Aadhaar number, address and medical history. He received a piece of paper with the number 111075 written on it. “I was a volunteer No. 11075. I was excited. It was finally happening, “he recalls.
He was soon taken to a large empty room, where his vital signs such as blood pressure were taken. In another room, a counselor explained the entire trial process, possible side effects, and the option that he could leave at any time if he did not feel comfortable. Blood tests were done to check for the presence of antibodies followed by a covid test. “At that moment, I got worried. What if I had antibodies? “He says, with a smile. After the tests were done, they gave him 1,000 rupees just like the other eight who had come as volunteers.” We did not know about the money. We were told there was a travel allowance for each visit. They asked us to come home and wait for a call to see if we met the criteria, “he says.
The next night, he received a call from the hospital asking him to return on September 10 for the first dose of the experimental vaccine. “I was more than happy. It was like he had won a jackpot, “he says. Once again, his vital signs were checked in the hospital; they were normal. Then he was taken to a huge room with 10-15 beds and five or six volunteers. It was all men, “he says.
About 80% of volunteers in Phase I and II trials are male, says Dr. JS Kumar, a professor of general medicine at the SRM Institute, who is part of the 15-doctor team for the covaxin trials. “In any drug trial, the number of women is less. We generally accept women who have completed a family or single women who are not planning a pregnancy for the next 1.5 years. Clinical trials require regular visits and updates, which often becomes difficult for women due to housework and other commitments, “she says.
Even in the Delhi trials, the number of women is small, says AIIMS’s Dr. Rai. At AIIMS Patna, three of the 46 volunteers were women in the phase I trial of covaxin, and eight out of 50 are women in phase II, says Dr. CM Singh, who leads the trials at the hospital in the capital of Bihar.
Minutes after Prashadh inspected the room full of men, a 5-foot-tall nurse in a lab coat and two masks approached him with a small injection. “I thought to myself, ‘Is this it? Did I spend so many days thinking about this? I was expecting an army of doctors with PPE, a huge syringe in hand, “he laughs.” Before the nurse gave me the injection, I asked if it would leave a mark, “he adds.
The jab didn’t hurt or leave a mark. After an hour’s break, the volunteers were directed to the pantry and served a thali with dal, paneer mutter, roti, and rice. They were then given a log book to record any headaches, fevers, or anything unusual they felt until their next visit. “We went home,” says Prashadh, whose next dose is scheduled for October 8. You have not faced any side effects to date. “Maybe they gave me a placebo,” he laughs.
.
