Volunteers are lining up for coronavirus infection
Human-challenge studies would hasten vaccine research, but the practice is considered controversial
When Gavriel Kleinwaks was a child, she was captivated by the story of Jonas Salk, the vaccine pioneer who tested a potential polio shot on himself, his wife and children in 1953.
Nationwide trials seen as the biggest public-health experiment ever later proved it worked.
Now, Kleinwaks is signing up to take part in another highstakes experiment.
The doctoral student at the University of Colorado is one of almost 30,000 volunteers willing to deliberately expose themselves to the novel coronavirus to test a potential vaccine, should researchers decide to proceed.
With the world desperate to end the pandemic, the idea of purposely infecting people with a dangerous pathogen that has no cure is fueling a debate over what kind of sacrifice is acceptable and the benefits such trials could bring.
Known as human-challenge studies, these tests can hasten research by placing volunteers in the path of the virus, rather than waiting for accidental exposure.
The controversial approach may become necessary at some point as the disease ebbs in some cities, making it harder to evaluate shots in the more conventional way, according to Pascal Soriot, CEO of drugmaker AstraZeneca. The company is working with the University of Oxford on one of the most advanced vaccines against the virus.
The lack of a drug to save people who are seriously ill is one of the main ethical concerns about human-challenge trials, along with limited knowledge about a virus that’s killed almost half a million people in several months.
A partnership launched by the U.S. National Institutes of Health isn’t planning to support such studies for COVID-19, the agency said in an email.
Still, the model is gaining more attention.
A project focused on human challenge studies led by the University of Antwerp and the Free University of Brussels attracted $22 million in Belgian government funding, the institutions said. The initiative to establish a facility and labs to test vaccines has drawn interest from drug companies, according to the universities.
Kleinwaks says she wrestled with doubts at first, but gradually grew more comfortable with the idea after assessing the risks.
Fueling her decision to volunteer, she says, is a lesson from the Talmud — saving one life is akin to saving the entire world — and a desire to help end the outbreak.
“We are all at risk of exposure every time we step out of our own home,” the 23-year-old engineering student said. “Nobody is guaranteed to be safe.”
The way vaccines usually are tested is by inoculating a large number of people and comparing their infection rates to those from a population of unvaccinated volunteers.
But waiting for both groups to become exposed to the illness in their regular daily lives to draw conclusions about whether the vaccine works can take months or even years.
The initiative that attracted Kleinwaks is organized by 1DaySooner, a group that advocates on behalf of people who want to join challenge studies.
The organization has held discussions with potential partners and vaccine manufacturers, said Josh Morrison, one of its founders.
Besides accelerating vaccine development, human-challenge studies ultimately could help make shots more effective, according to the World Health Organization, which has outlined the criteria that would need to be met to carry out the tests.
Proponents note the approach was used safely for diseases such as malaria, typhoid, cholera as well as the flu.
But the studies could take at least several months to start, and the NIH said there should be enough natural transmission of the virus in the U.S. to carry out tests this summer.
The agency also cited “serious ethical considerations.”