Earlier this year, Ritabrata Mitra says his world came crashing upon him. An engineering-cum-business analytics student who had been placed in a multinational during his final year in university just before the Covid-19 outbreak, the 25-year-old spent much of the next few months fearing the inevitable. Many of his friends were telling him that the companies they had been placed in were rescinding their offers.
Mitra gave up his paying guest accommodation in Kolkata and moved back into his home in Diamond Harbour, a small city located at a little over two-hour car journey from Kolkata. The outbreak has been particularly stressful because both his parents suffer from several co-morbidities, ranging from hypertension to neurological and cardiological conditions; his father even had to postpone a surgery. Mitra spent the next few months with his parents waiting for the letter. When it arrived, he was still wracked with grief. “It was heartbreaking. It was going to be my first job,” he says. He began to apply for other jobs too, but none were hiring.
It was around this time—moved by frustration over what was going to befall him and others like him—that Mitra began to sign up as a volunteer for vaccine trials in India. He began to email vaccine manufacturers (Bharat Biotech, Zydus Cadila and Serum Institute of India), started contacting centres such as AIIMS in Delhi (which carried out early trials of Bharat Biotech’s vaccine), and began ringing WhatsApp numbers set up to enrol volunteers for early trials in Delhi. At some point, he even started messaging some of these companies on their Facebook accounts. “You can’t just wait for something good like the vaccine to happen. You have to be ready to be a part of its discovery too,” he says.
Mitra is now, he says, registered to participate for Bharat Biotech’s vaccine trials when they take place in Kolkata. But Mitra doesn’t just wish to be part of a vaccine trial.
He wants to be infected with Covid-19 too.
Although most Covid-19 vaccine candidates are working on exceptionally expedited timelines—and several unconventional methods are being used to speed up the process such as the clubbing together of Phase 1 and 2 clinical trials, or the doing away with excessive regulations around the granting of permissions—the likes of Mitra want to further shorten this timeline.
In the final Phase 3 trial, once participants are given either a shot (or more) of the vaccine candidate or the placebo, they are sent back to their normal lives to encounter the virus naturally. Some may get infected; some may not encounter it. At no point are they encouraged to increase their likelihood to encounter the virus. They aren’t told to forego their masks or social distancing rules. Doing such a thing would be considered unethical.
But to learn if a vaccine candidate works or not, it is essential that participants encounter the virus. The study’s designers work around this by enrolling a large pool of participants, especially in areas or countries which are in the midst of high infections; and also stretch this final phase over several months.
What the likes of Mitra are campaigning for is that this whole process can be shortened and fewer participants required if some volunteers (those who are young and healthy and, thus, in a less risky demography) are simply allowed to get infected with the virus after a shot of the vaccine. “It sounds dangerous, I know. But if you really calculate the risk it poses to us who are healthy and young—there’s a higher chance I can get run over by a random car tomorrow than die from the virus,” Mitra says.
Globally, some researchers have begun advocating this method, also referred to as human challenge trials. An advocacy group, 1Day Sooner, has come up, which has been both campaigning and collecting volunteers for such a method. Last month, they got several prominent researchers and thinkers (some of them Nobel laureates) from linguist Steven Pinker and philosopher Daniel Dennett to Adrian Hill, whose lab at the University of Oxford is developing one of the leading Covid-19 vaccine candidates, to sign an open letter urging the US government ‘to undertake immediate preparations for human challenge trials’.
But all this is still in the realm of theoretical debates. Human challenge trials have been used to test vaccines for diseases such as malaria and cholera, but in these cases, there are drugs that can help a participant recover in case the vaccine doesn’t work. In the case of Covid-19, no such drug exists. Hence, even if the probability of falling severely ill or dying from Covid-19 is statistically slim for the young and healthy, the possibility still remains.
While it still remains a theoretical discussion, there has been some movement in recent weeks. Government scientists in the US have begun efforts to manufacture a strain of Covid-19 that could be used in such trials. The National Institute of Allergy and Infectious Diseases in the US has announced that it has begun investigating the technical and ethical considerations of conducting such studies, ‘including efforts to manufacture a suitable Covid-19 strain, draft a clinical protocol and identify resources that would be required to conduct such studies’. Some vaccine developers like Johnson & Johnson have also announced that preparations to stock the virus for possible challenge trials are underway.
Many vaccine candidates are entering the business end of their trials. In India, the Oxford vaccine candidate has just begun its Phase 2 trials; Bharat Biotech and Zydus Cadila started Phase 1 and 2 trials, respectively, in August. Many more vaccine candidates will be trialled going ahead. Even if the scientific community and regulators are unable to rest their ethical concerns over such trials by the time many vaccine manufacturers start trialling their candidates, there could come a time, its advocates say, when this method could be used to triage the best among several leading vaccine candidates.
“People are very correct to say this is unethical,” says Shahrukh Ahmed, a 26-year-old working as an accountant for an NGO in Kolkata. “But we have to remember, this is an unprecedented situation. We have to rethink what is ethical and unethical during a pandemic such as this. The benefits that will come with such a trial will far outweigh the risk the virus will bring to someone like me.”
Ahmed, like Mitra, wants to volunteer for a human challenge trial. Although he didn’t directly suffer from the pandemic—in fact, Ahmed looked forward to the lockdown to bring about what he calls self-improvement, learning to brush up his writing skills and using online tools such Microsoft PowerPoint—the pandemic began to weigh him down. Two relatives in his extended family passed away from Covid-19. He began to engage in the relief work his NGO carried out in Kolkata and nearby areas and to see firsthand how difficult the situation had become for some. “We might have gone to our village [in Murshidabad] during this period. But we couldn’t do that too. Even Eid just went and came,” he says. “It just became so intense that I really wanted to do something, something like this trial.”
The pandemic has affected everyone. But to many youths in India, this has been an especially bitter experience. They have found themselves mostly indoors, watching older relatives suffer severely or succumb to the disease, while a cloud of uncertainty has settled over their career prospects. The 1Day Sooner campaign has so far attracted nearly 36,000 volunteers ready to infect themselves for trials from 160 countries. Many of these are young Indians in distant towns and cities whose job prospects now appear shaky and who have seen relatives succumb to the virus. Many of them, already helping out in relief work and blood donation camps, appear to be driven by a need to do more, to set aside personal security for a greater good.
Akash Saggam is a 28-year-old biochemist from Pune who believes India, with its own vaccine candidates, could shine in this outbreak. He hopes he can be a participant in a human challenge trial around one of the Indian vaccines. “That is my dream right now,” he says.
The son of a salesman in a large store, who spent much of his early life in a house around 100 sq m with three other family members, things have been looking up for his family for a few years now. He is part of a research team in collaboration with a leading vaccine manufacturer studying the potential benefits of integrative medicine, such as ayurvedic products, as a vaccine adjuvant. His brother works in a large app-based company and the family now lives in a large three-storey house in Pune.
Because he now works at the lab set up in the vaccine manufacturing company, every day he is assailed by at least five or more queries about the Covid-19 vaccine in development. “People always ask you on WhatsApp, Facebook or even in person, even friends I’m not in touch with anymore. It gets annoying,” he says. “Because none of them really care about the science. They won’t really enrol to become volunteers. But they will want the vaccine.”
Although these volunteers might be putting themselves at risk, Mitra reasons, there is also much to be gained. “You are getting access to a possible vaccine much earlier. And whatever happens, even if the vaccine doesn’t work, you will get the best healthcare facilities and you will be monitored by top doctors and scientists. If you get Covid-19 outside this—and it’s very possible given how quickly it is spreading—you will mostly be on your own.”
But for all the assuredness of their convictions, like all good Indian youths, the biggest stumbling block often comes at home, in front of their mothers. Mitra took a while to convince his parents. Ahmed has still not told his. A few years ago when he tried to register himself as an organ donor, his parents scuttled it. This time, he says, he will bring them around to the idea slowly.
Even Gopal Bhattacharyya from Dhanbad, who at 55 years of age is an anomaly in this group of volunteers, had difficulty getting the go-ahead at home. “My wife, after some persuasion, agreed. But my mother [84 years old] has been most reluctant,” Bhattacharyya said. They finally agreed on the condition that Bhattacharyya’s son—who also wanted to become a volunteer—didn’t sign up. “They couldn’t allow both male members of the family to be at risk. What if something happened?” he says.
Bhattacharyya, a popular figure in the city who organises blood donation camps, scoffs at the notion that only youths should volunteer since they fall in a less risky demography. “I have seen in my camps 20-year-old boys shaking at the sight of a needle. Blood donation camps or vaccine trials, for volunteers what you need is courage,” he says.
Bhattacharyya is a peculiar character. All through the lockdown, he says, he was out in the streets carrying out relief work, or, when it was possible, organising blood donation camps. “It got really bad because in Dhanbad, blood banks were having difficulty sourcing blood. So I used to go to homes and get people to come. We had to take precautions in these camps, like maintaining social distancing norms, changing used items like bedsheets constantly,” he says. During the lockdown, Bhattacharyya arranged five such camps, collecting over 200 units of blood. Since then, he has been organising such camps every other weekend.
Around three weeks back, a close friend of his who had contracted the virus passed away. “I was with him all through the time, getting hospitalised, taking care of him in the hospital. I checked myself, but I was negative… The point I’m trying to make is that we can catch the virus anytime, either from my friend or in one of these camps. But you can’t let it come in the way of your life or helping someone,” he says.
A few weeks ago, Mitra finally heard back from a company he had applied for a job. He was being recruited, although at a much diminished pay. “I’m quite happy about it,” he says. “It makes you feel that however gloomy things become, eventually one can find a way through.”
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