Young volunteers willing to take 'calculated risk' in human challenge vaccine trials

At 20, Abie Rohrig of New York City has already taken on one major calculated risk.

"Last summer, I donated my kidney to a stranger, and that was a very moving experience for me," Rohrig says.

Now, the Swarthmore College student is ready for another medical gamble.

So is Sunash Sharma, a 23-year-old Pasadena, California software developer.

"I'm seeing how this pandemic is really hurting a lot of people, a lot of families," Sharma says.

To fight back, Sharma and Rohrig have joined 1Day Sooner, and a grassroots organization with more than 36,000 volunteers, who are willing to be deliberately exposed to COVID-19 as part of a "human challenge" vaccine trial.

"We want to take this calculated risk," Sharma says. "I feel like I need to do what I can to get a vaccine delivered sooner."

In typical vaccine trials, participants are given a candidate vaccine or a placebo, then sent back into their regular lives, where they may or may not be exposed to the virus in their community.

In a human challenge trial, volunteers are inoculated or given a place, and then they are directly exposed to the virus in a controlled setting.

Rohrig and Sharma both are in excellent health, and they are both at lower risk of developing severe complications of COVID-19.

Still, this virus can be unpredictable, and there is no "rescue" medication, to reverse a sudden worsening of the disease.

Tuskegee University bioethicist Dr. Reuben Warren is concerned volunteers may not fully understand the risks that are relayed during the informed consent process.

"Oftentimes, we think people understand, and they don't," Dr. Warren says. "We know what we say, but we really don't know what they hear."

Rohrig says he is so confident in the idea of participating in a human challenge, he has taken a gap year off from college to work for 1Day Sooner.

"It is a little unnerving when I think about the possibility of getting COVID-19," he says.  "I mean, I certainly don't want to get COVID-19."

But, Rohrig says, he has done one of his homework and has decided this is another calculated risk he is willing to take.

"Because instead of just helping one person, like I did when I donated my kidney, I can potentially help the whole world get a vaccine," Rohrig says.

The head of the Oxford COVID-19 vaccine trial has expressed interest in human challenge trials.  Josh Morrison, the executive director of 1Day Sooner, insists this project should not be perceived as competing with more traditional COVID-19 vaccine trials.

"Human challenge trials are also a compliment to the Phase 3 studies, not a replacement," says Morrison. "because we can't necessarily assume the exact dose tested in those studies or vaccines being tested are going to be the final dose or best vaccine that's ever going to be developed."

On the organization’s website, 1Day Sooner lists 36,600 volunteers in 140 countries, who are standing by, willing to participate in a human challenge trial.