why I support the world’s first COVID vaccine challenge trial

Two months ago I received an email from a colleague inviting me to join a global campaign to support a form of vaccine research that would involve deliberately infecting volunteers with COVID-19. This may seem like a strange idea. Some people have expressed concern about this research. Some even think it would violate the Hippocratic Oath for a physician to expose research participants to harm in this way.

But as a physician, ethicist, and researcher, I strongly support COVID-19 challenge trials. I responded immediately and joined more than 150 scholars in an open letter advocating preparation for these essays. This week, there are reports that the first of these trials will begin in London in 2021. Special research facilities are being developed, and several thousand young people in the UK have already volunteered to be part of the trial.

An ethical imperative

The basic argument in favor of challenge trials is remarkably simple. The pandemic has caused massive damage, both directly and indirectly. To date, it has caused more than 30 million documented infections and nearly a million deaths. It has caused the worst economic recession since the Great Depression.

Developing an effective vaccine is our best hope of escaping the pandemic and returning to something like a normal life. Also, the sooner we develop a vaccine, the better. If we can identify and make a vaccine available even a month earlier, it would potentially save tens of thousands of lives.

Challenge tests have been used in vaccine development for many years. Standard phase 3 vaccine research studies administer the vaccine (or a placebo) to thousands of people and wait for some of them to develop the infection naturally. This can take months or years. By comparison, challenge studies involve a relatively small number of volunteers who are exposed to both the vaccine and the virus. In a short time, it can become clear whether the vaccine is good or not.

Challenge studies are not the only form of research needed, but there is real hope that they can help. They can be particularly important in determining which of the many vaccines in development is the best.

Risk balancing

The reason COVID-19 provocation studies are controversial is because they carry significant risk. Unlike other diseases that have been studied in this way, such as malaria, cholera, and influenza, there is no definitive treatment for COVID-19. There is a risk that volunteers will become seriously ill or even die as a result of their participation in the trial.

But the planned challenge studies are designed to keep that risk as low as possible. They would involve healthy young adults who have the lowest risk of serious complications from COVID-19. They would be closely monitored in a dedicated research facility with access to the best available treatment if they did become ill.

In addition, we have to balance those risks with damages if we do not conduct impeachment trials. If a vaccine is delayed or we end up using one that is less effective, it will result in serious illness and the death of many more people.

Volunteers

It may be easy for me to support the study. I would not be eligible to participate. The exact criteria are not yet available, but the London study is likely to restrict it to healthy young adults.

But I have an 18 year old son who could join. Would I be willing to have my own child participate in a COVID-19 challenge test?

I would worry, like any parent. He would probably lose sleep. I’d like to read the fine print and talk to him to make sure he clearly understands what it entails and the risks. Informed consent will be at the center of any challenge study, and everyone who participates should enter with their eyes wide open.

But although I would worry about the risks, they are, in essence, the same risks that he faces, that we all face, every time we leave our home. Despite efforts to contain the spread, many of us will still be exposed to the coronavirus this winter.

And, if you were still willing to volunteer for a challenge study, if you wanted to join the more than 37,000 volunteers around the world who have signed up to participate in challenge trials, you would be immensely proud. Those volunteers are doing something very similar to those who volunteer for the military in wartime or sign up for humanitarian relief jobs in difficult and dangerous parts of the world. They recognize the seriousness and urgency of the need and how they could make a material difference. They deserve our admiration, our support and our thanks.