PD Editorial: Brave volunteers test coronavirus vaccines

Absent national testing, contact tracing and quarantine that the Trump administration seems disinclined or incapable of pursuing, a safe, effective vaccine is the only way to truly put the COVID-19 pandemic behind us.

As Bill Gates wrote in a recent blog post, “Realistically, if we are going to return to normal, we need to develop a safe, effective vaccine. We need to make billions of doses, we need to get them out to every part of the world, and we need all of this to happen as quickly as possible.”

Thankfully, work is progressing on multiple fronts around the world. Before a vaccine can be approved, it has to go through three stages of human trials. The first stage is to determine whether the vaccine is safe. The second stage determines whether it actually triggers an immune response. Finally, Stage 3 establishes if it actually offers broad protection against the virus.

The first stage is critical, and it couldn't take place without healthy volunteers willing to risk taking an untested vaccine that has not been proven safe in humans.

A vaccine under development by the National Institute of Allergy and Infectious Diseases and Moderna Inc. began Phase 1 testing in March with 45 volunteers. It will soon be expanding with 60 more after Moderna released promising preliminary results.

This pandemic has created many heroes, from doctors, nurses and other frontline health care workers willing to risk themselves to treat their patients to the essential workers who also take risks to keep food on grocery store shelves, keep the power on and otherwise keep society functioning as the rest of us hunker down or work from home.

People who volunteer for vaccine trials are heroes, too - doubly so because they are brave enough to volunteer before the normal testing on animals is complete.

“We may not be able to minimize the risks as much as we would hope to, because we have the time pressure of the outbreak,” Holly Fernandez Lynch, an assistant professor of medical ethics at the University of Pennsylvania, told STAT News.

Amazingly, more than 25,000 people in more than 100 countries have volunteered to undergo something even riskier to speed the development of a coronavirus vaccine: human challenge trials.

Ordinarily, the third phase of vaccine trials studies the outcome of a large number of participants, some of whom are inoculated and some of whom receive placebos to see whether there is any difference in their infection rate as they go about their daily lives.

But because of social distancing and other precautions, it could take months to develop the data necessary to determine whether a vaccine is effective. In a challenge trial, volunteers who have been inoculated are intentionally exposed to the virus under controlled conditions to see if they are protected.

This is an intriguing idea given the urgency of finding an effective vaccine. But given the substantial risks to volunteers, it should only be considered for the most promising vaccines - and only after ensuring that volunteers are fully informed of the dangers they are exposing themselves to.

A vaccine against the coronavirus will help the world get back to something resembling normal. Those helping get us there more quickly deserve our gratitude.

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