STANFORD, CA — At least two Stanford graduates have signed up for a medical study that in normal times would be unthinkable.
Sophie Rose, 22, and Carson Poltorack, 23, are among 3,300 worldwide who’ve signed up for a “human challenge study” that aims to accelerate the vaccine testing process by deliberately exposing subjects to the new coronavirus, The San Jose Mercury News reports.
To say the idea of infecting healthy subjects with a deadly virus for which there is no approved treatment pushes the medical ethics envelope would be an understatement.
The double-blind subjects would be given either a vaccine or a placebo, meaning it would be expected that some of those enrolled would become sickened.
The COVID-19 death rate for those in their 20s is approximately 0.03% and about 0.085% among those in their 30s according to the report, which cites data from China.
Human challenge studies for COVID-19 have not yet been approved.
Rose and Poltorack, who signed up for the study through 1DaySooner, a group that’s advocating for the study and recruiting potential subjects, believe the “challenge study” is worth the risk.
“The widespread suffering and loss of life we’re seeing, as well as the sustained damage to national economies, international relations, and societal stability — it’s severe enough that any meaningful reduction in that damage could drastically improve the health and well-being of so many people,” Rose told the Mercury.
“I’m in a position to be able to take on that risk — why not me?”
Poltorack acknowledged that he’s not signing up without some trepidations.
“Yes, it is a huge sacrifice. It should be honored, not discouraged. Sacrificing your time and your health is one of the most powerful things that someone can do. I’ve made peace with it,” he told the Mercury.
“I’m not stoked about it. If there is a better way to reduce fatalities, sign me up. I’d be glad to do it in a different or better way.
“If it accelerates vaccine development by a month, that prevents millions of infections globally and saves countless lives. The math works out.”
Reflecting the urgency of this pandemic, the idea of conducting such a study is gaining the support of public officials and epidemiologists, The Hill reports.
Rep. Donna Shalala (D-Fla.), a former Health and Human Services Secretary, is among 35 House lawmakers who wrote a letter advocating for the controversial study, the Hill report said.
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“Our situation in this pandemic is analogous to war, in which there is a long tradition of volunteers risking their health and lives on dangerous missions for which they understand the risks and are willing to do so in order to help save the lives of others,” they said in the letter.
Harvard University epidemiology professor Marc Lipsitch advocated the human challenge study in a Journal of Infectious Diseases article he co-authored.
“People volunteer for the military, they volunteer to become emergency medical technicians,” he told The Hill. “All of those carry medical risks for the benefit of someone else and people do it.”
Food and Drug Administration spokesman Michael Felberbaum issued a statement to The Hill expressing skepticism about the possibility of approving human challenge trials.
“The FDA is exploring all possible options to most efficiently advance the development of safe and effective vaccines that will prevent COVID-19,” Felberbaum’s statement said. “… human challenge studies used to develop a COVID-19 vaccine may present ethical and feasibility issues that can be avoided with the use of animal models.”
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