Contributor: Gabby Keb, Chapter Vice President
In response to the current SARS-CoV-2 pandemic, scientists in research and development are racing to produce an effective vaccine. The U.S. government has named this goal Operation Warp Speed and aims to deliver 300 million doses of the vaccine by January 2021. Operation Warp Speed is a partnership between multiple groups such the Center for Disease Control and Prevention (CDC), Food and Drug administration (FDA), Department of Defense (DoD), and Biomedical Advanced Research and Development Authority (BARDA).
In June, Operation Warp speed gave billions in federal funding to support vaccine candidates. As of July, the top candidates reaching Phase 2/3 trials are a nonreplicating vector from The University of Oxford/AstraZeneca and an RNA-based agent from Moderna. Both candidates have been shown to produce good immune responses, but it is still unclear whether these responses will be protective and prevent infection or keep people from falling ill while remaining infectious. Studies to answer these questions will take more time and delay vaccine distribution.
One way to determine if a vaccine is effective is to wait for enough vaccinated volunteers to encounter the virus in their daily lives then test whether they become infected. Another way is through ethically controversial “challenge studies.” For these studies, vaccinated volunteers are willingly exposed to the virus to accelerate vaccine development and presumably save lives. Challenge studies have been used against other disease agents like cholera, malaria, typhoid, and dengue fever; however, treatments were available for patients who fell ill unlike COVID-19.
It is unethical to knowingly put a volunteer at risk of illness or death without being able to ensure safety. Individuals in support of challenge studies argue that the risks leading to hospitalization and death are low in healthy, young, and fit individuals that challenge studies would be limited to and argue that it would be unethical not to accelerate development. A group of more than 100 individuals including expert scientists, Nobel Laureates, and government officials have signed an open letter in favor of challenge studies and emphasize the need for ethical discussions.
A recent article published in Science Insights nicely summarizes the ethical framework for COVID-19 controlled human infection studies (CHIs). As students in science, I think it is important for us to also engage in ethical discussions with our peers and colleagues. So, I ask you, should challenge studies be pursued?
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