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Covid-19 Vaccine Trials Rely on Volunteers. Their Contribution Is Essential.

One volunteer weighs in on her decision to join the world's most urgent vaccine race.

News

Covid-19

A scientist working at the Oxford Vaccine Group's laboratory facility at the Churchill Hospital in Oxford June 24, 2020, as part of the effort to develop a Covid-19 vaccine. (Photo by Steve Parsons/AFP)

Deblina Chakrabarty, a media professional in London, isn’t worried about being a carrier of the Covid-19 virus. As a volunteer in a major vaccine trial, she gets tested every week.

The vaccine, which the University of Oxford is currently developing in partnership with the pharmaceutical company AstraZeneca, is currently a frontrunner in the worldwide race. Reuters reported that the company plans to produce 3 billion doses.

When pandemic-led closures were announced in the UK in mid-March, Chakrabarty, a vice president for the MGM Worldwide Television Group, was on a work trip to Dubai. She managed to fly back safely, but found home very different from the place she’d briefly left.

“Our lives changed overnight. We were at home with nowhere to go, looking out at deserted streets. It felt a bit apocalyptic and like most people, I felt helpless,” said Chakrabarty. “I kept wondering what I could do to be part of any solution that would help people get back to normalcy, good health, and livelihood.”

She initially donated to her local food bank and volunteered her time at a nearby hospital, helping distribute food that was suddenly being donated in large amounts by restaurants for the National Health Service.

Unlike many people, Chakrabarty said, “I wasn’t paralyzed by fear. I went right up to the wards with Covid-19 patients to drop off food at the door. We weren’t given masks or gloves because the PPE was reserved for medical professional working inside the wards.”

But it didn’t feel like enough. Chakrabarty wanted to contribute to an effort that felt more meaningful and went further.

Then she saw a call for trial volunteers on the app Nextdoor.

Coming across the volunteer recruitment link set a spontaneous ball rolling for Chakrabarty. “I wanted to find a way to put my lack of fear to good use, and voila, the vaccine trial came along,” she said. “Given its pedigree of being developed by Oxford and as a public-private partnership, it does feel like a contribution to science and humanity.”

Dr Jonathan Kimmelman, a professor of biomedical ethics at McGill University, concurred.

He pointed out that non-human, or animal models, are not especially predictive of how human beings will respond to a drug or vaccine. “Most of our hypotheses regarding drugs and vaccines turn out to be wrong,” he said. Drugs and vaccines tend to be too ineffective, or not safe enough, for general use.

“Human volunteer trials are therefore critical for evaluating safety and efficacy before we disseminate a vaccine or drug to clinical practice.”

But vaccine research isn’t without its ethical issues.

“Vaccine research raises special concerns, because vaccines are used on healthy people to prevent them from getting sick rather than on sick people to make them well,” said Dr. Amar Jesani, senior bioethicist and editor of the Indian Journal of Medical Ethics.

“The trial protocol must be scientifically sound and available in the public domain. There must be arrangements to take care of participants who fall sick during the trial. If the vaccine is proven safe and effective, it must be available to all who need it at a reasonable rate.”

Transparency and trust are key, as a report published by the Lancet makes clear. “The success of COVID-19 vaccines hinges on community trust in vaccine sciences, which requires comprehensive and transparent evaluation of risk and honest communication of potential harms.”

And Chakrabarty had her reservations.

“I spoke with friends who have scientific training and background and those who work in pharma,” she said. “They were very supportive because they know how crucial participation is to the success of drug and vaccine trials, especially of minority populations.”

Those same friends also helped her understand the sound science behind the trial, she said. “The protocol of the vaccine was an established adenovirus vector from the MERS vaccine trial. It wasn’t funky, unknown science.”

Today, Chakrabarty is one of about 10,000 volunteers in the trial’s second phase. Since the trial is blind, she doesn’t know whether she’s one of the volunteers who’s actually received the vaccine.

But both groups, whether they receive the actual vaccine or the control drug, are equally valuable to the trial. As Dr. Kimmelman said, “Done properly…clinical trials are not merely ethical. They provide a public service.”

Chakrabarty has interwoven this public service into her daily routine. She believes it is her duty to be outside her house to a reasonable extent.

“Assuming that I’ve been given the vaccine dose, I am a waste in the study if I’m not exposed to people. Unless I’m out and about, possibly coming in touch with asymptomatic people, how can we figure out whether I developed antibodies or had a mild response to the virus?” she said.

As she awaits her second blood test in September, Chakrabarty is hopeful. “We used to know time as AD or BC and now it seems to have become…After Vaccine,” she said. “I’m happy to be a part of the 10,000 people that take humanity to [that point].”

Kinjal Dagli-Shah is a Toronto-based journalist with more than 15 years of experience working in newsrooms in India, the United States, and Canada.

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