Covaxin: Behind the scenes of the Covid-19 vaccine trials5 min read . Updated: 22 Sep 2020, 06:50 PM IST
- A desire to help, nationalism and a sense of wanting to be part of history are among the reasons driving volunteers to participate in vaccine trials
- About 80% of volunteers in the Phase I and II trials are men, says Dr. J.S. Kumar, professor of general medicine at SRM Institute, who’s part of the 15-doctor team for covaxin trials
New Delhi: The moment Kumara Prashadh saw a post by a Chennai doctor on Twitter in August, requesting people to volunteer for the phase II clinical trials of covaxin, he knew he had to participate. Like much of the world, the IT employee was closely following news about the race to develop a vaccine for the novel coronavirus. Since covaxin was India’s indigenous covid-19 vaccine, Prashadh considered it his duty as a citizen, but he’d also read about a shortage of volunteers in the UK for vaccine trials. “I didn’t want that to happen in my country. I hope my country wins this race," he says.
A desire to help, nationalism and a sense of wanting to be part of history are among the reasons driving 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 fearlessness as well as a nerve-wracking experience, especially since volunteers are given a weakened version of a pathogen. But that hasn’t stopped people from coming forward 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 had never seen this kind of reaction. Of course, social media and news channels helped us reach more people," says Dr Rai, who’s part of the team conducting covaxin trials. They selected around 100 people for Phase I. For Phase II as well, the response was good. “Within a day, our inbox had about 800 emails," Dr Rai says, regarding Phase II, for which they finally selected 90-100 people. Among the reasons most people have come forward, says Dr Rai, are “patriotism and the desire to quickly have a vaccine."
These were precisely the reasons why a 30-something businessman participated in the Phase II Delhi trials. “I went against my family’s wishes. I understand their 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 wish to be named. He’s now waiting to get the second dose.
In Chennai, Prashadh also prevailed over the concerns of his family and decided to volunteer at SRM Institute of Science and Technology, one of the 10-plus institutes across the country selected by the Indian Council of Medical Research (ICMR) for trials of the vaccine developed by Bharat Biotech.
Prashadh called SRM and registered on the phone, but it’s only when he got into his car on the morning of 8 September to drive from his house to the institute that the enormity of what he’d signed up for struck him. “I had read enough about trials and the research that goes into creating a vaccine. I was confident and excited, but also anxious. During that drive, a few questions kept going in my head: What if I have asymptomatic covid? What if I contract the virus while walking in the hospital corridor?"
At SRM, Prashadh had to fill a form with details like his Aadhaar number, address and medical history. He got a scrap of paper with No. 111075 scribbled on it. “I was volunteer No. 11075. I was thrilled. It was finally happening," he recalls.
Soon he was taken to a big empty room, where his vitals like blood pressure were taken. In another room, a counsellor explained the whole process of the trial, the potential side effects and the option that he could walk out at any point if he wasn’t comfortable. Blood tests were done to check for presence of antibodies followed by a covid test. “At that point, I got worried. What if I had antibodies?" he says, with a chuckle. After the tests were done, he was given Rs1,000 as were the other eight who had come to volunteer. “We didn’t know about the money. We were told it was a travel allowance for each visit. We were asked to return home and wait for a call to hear whether we fit the criteria," he says.
The next evening, he got a call from the hospital, asking him to return on 10 September for the first dose of the experimental vaccine. “I was beyond happy. It was as if I had hit some jackpot," he says. Once again, his vitals were checked at the hospital; they were normal. Then he was taken to a huge room with 10-15 beds and five-six volunteers. “They were all men," he says.
About 80% of volunteers in the Phase I and II trials are men, says Dr. J.S. Kumar, professor of general medicine at SRM Institute, who’s part of the 15-doctor team for covaxin trials. “In any drug trial, the number of women is less. We generally take women who have completed a family or unmarried women who are not planning pregnancy for the next 1.5 years. Clinical trials require regular visits and updates, which often become difficult for women because of household work and other commitments," he says.
Even at the Delhi trials, the number of women is few, says Dr. Rai of AIIMS. At AIIMS Patna, three out of 46 volunteers were female in the Phase I trial of covaxin, and eight out of 50 are women in Phase II, says Dr. C.M. Singh, who’s leading the trials at the hospital in Bihar’s capital city.
Minutes after Prashadh surveyed the room full of men, a 5ft-something nurse in a lab coat and two masks approached him with a small injection. “I thought to myself, ‘Is this is it? I spent so many days thinking about this?’ I expected an army of doctors in PPEs, a huge syringe in hand," he laughs. “Before the nurse gave me the injection, I asked if I would leave a mark," he adds.
The jab neither hurt nor left a mark. After an hour of rest, the volunteers were directed to the pantry and served a thali with dal, paneer mutter, roti and rice. Then they were given a log book to jot down any headaches, fever or anything unusual they felt until their next visit. “We left for home," says Prashadh, whose next dose is due on 8 October. He hasn’t faced any side-effects till date. “Maybe they gave me a placebo," he laughs.