The global race to find a Covid-19 vaccine took a leap forward with Pfizer and BioNTech claiming theirs 90% effective. Sophie Rose, a 22-year-old Stanford University graduate and co-founder of 1 Day Sooner - an organisation recruiting volunteers for potential human challenge trials - talks ethics and risks behind the work for a vaccine
What exactly is a human challenge trial, and how could it help develop a coronavirus vaccine?
Participants are given the coronavirus vaccine (and some are given a placebo) and then they are directly exposed to the coronavirus. Knowing 100% of participants have been exposed makes it easier to judge the vaccine’s effectiveness. In normal vaccine trials, the volunteers go about their regular lives and may or may not encounter the virus in the wild. We analyse to see if they get sick less often than those who received the placebo. If this is true, it means the vaccine is effective.
Why is a human challenge trial better than a regular vaccine trial?
HCT means you are not waiting for six months to a year and a half. We don’t have that kind of time to lose. Not only are people dying but there is also an economic and wellbeing toll to consider.
Talk us through the conception of 1 Day Sooner…
I read a paper published in the Journal of Infectious Diseases and it proposed the idea of using challenge trials for Covid-19. I really wanted to leverage my existing skill set in order to do something useful and HCT interested me. I decided to join forces with a couple of other people in my professional network and make the group a reality.
Who thought of the name?
One of our co-founders, Josh Morrison, threw it around and it really resonated with the rest of the team. The idea being that even bringing a vaccine to the global community one day sooner has the potential to save thousands of lives.
Globally, there has now been over 1.26 million deaths. What’s the next stage for 1 Day Sooner?
We are continuing to recruit volunteers and lay the groundwork so if ethicists, researchers and other relevant stakeholders decides these trials are the best option, we are ready to start them as soon as possible. We hope that recruiting enough willing people will help convince policymakers that a HCT is a viable option towards accelerating the development of a vaccine against the coronavirus.
Is it ethical infecting people with a disease that could kill them?
There are still important ethical and scientific conversations ongoing about whether these trials are the best option to finding a coronavirus vaccine. A recent document published by the World Health Organization (WHO) states: “well designed challenge studies might thus not only accelerate COVID-19 vaccine development (7–9), but also make it more likely that the vaccines ultimately deployed are more effective.”
But our current view is yes, there are risks to individuals, but we perceive those risks to be reasonable. Research from the US and China shows one in 3,000 people aged 20-29 die from Covid-19: this means the HCT trial risk is equal to donating a kidney, which is something we freely allow people to do. Undertaking HCTs could be justified on the basis of the potentially enormous social benefit they might achieve. Plus, there would be a robust, informed consent process.
Who are the volunteers taking part?
Researchers and trial designers would select participants carefully – as of right now, that would look like people who are young and with no underlying health conditions.
You had more than 29,000 people from 102 countries volunteering. Did this surprise you?
Yes and no. One of the things that has impressed me over the past few months has been people across the world have come together and shown collective action. Firstly in the face of Covid-19 and now in the face of racial injustice, following the death of George Floyd. It’s been inspiring to see.
Why do think people signed up?
There are many varied reasons, but largely people believe the level of risk to themselves is acceptable given the larger benefit to society. Interestingly, I’ve been told by medical students that they want to be involved because they have a good understanding of what these trials entail and they are frustrated as they are not able to help alleviate the burden of Covid-19 through practicing medicine – because they are not far along enough in their education. Volunteering is a way for them to contribute and potentially accelerate finding a coronavirus vaccine.
Do you know anyone affected by Covid-19?
I do, sadly. A couple of close people in my life have lost loved ones due to Covid, which has been really hard to see. I think it’s been difficult for everyone, especially because you can’t come together with your loved ones. I do worry about my grandparents, who are high risk and living in Australia.
How do your family feel about you living so far away from them, and doing the work that you do?
I grew up on the east coast of Australia in Brisbane and moved out when I was 17 to study Human Biology at Stanford University in California. So, for the past five years, my family have become fairly used to having me at arm’s length. But we are very close and talk frequently, and they are very supportive of the work that I do. Last December I moved to the University of Oxford, to do some research, so I’m currently the furthest away from home I’ve ever been.
Judging from your qualifications, it seems fair to say you’ve been interested in pandemics before they became the talk of the planet…
Selfishly, I sometimes feel quite lucky that I am living through something I am so passionate about working on – an unexpected positive to an otherwise awful situation. It’s an unexpected opportunity. Being prepared for a pandemic is something scientists have been talking about for a long time and I’m hoping this situation helps to inform health policy so we are in a better position for next time.
For more information on the work of 1 Day Sooner see 1daysooner.org