They want to take part in a "human challenge trial," an ethically controversial vaccine test that infects people with a virus does not yet have a cure.
1 / 4Imagine being told to inhale a nasal spray full of coronavirus. More than 14,000 people in the U.S. and elsewhere are putting their names forward to do so.
The problem is that vaccines take time to develop and test — often, upwards of a decade. The final phase of vaccine testing usually requires tracking up to tens of thousands of people to see who becomes infected in their daily lives, sometimes over several years. "I definitely think it's going to be pursued," said Dr. Matthew Memoli, director of the Clinical Studies Unit at the National Institute of Health's Laboratory of Infectious Diseases."So many things could change, but I think it's likely we could see one at some point in the future."
"Challenge trials may end up pushing the envelope when it comes to reasonable research risks," said Dr. David Magnus, director of the Stanford Center for Biomedical Ethics."I don't know how far that will be pushed before people say no." Wildfire heads the"Infectious Disease and Human Challenge Unit" at SGS, a multinational testing company worth nearly $20 billion, which runs studies across sectors from cybersecurity to agriculture. They've done influenza and malaria challenge studies, and Wildfire is now working on a proposal for COVID-19.
No company has publicly pursued a COVID-19 human challenge proposal in the U.S., though they have increased over the past decade for diseases like cholera, influenza and malaria. The ethical framework for what passes comes largely from a 2001 paper by NIH experts than emphasizes"minimal risk," an area where COVID-19 pushes the boundaries.
The FDA said development of safe and effective vaccines will need to be"carefully conceived and rapidly executed," and formal determinations on human challenge trials will be made on a case-by-case basis. Memoli has infected more than 500 people with the flu. He knows what it's like to sit in a hospital with sickened volunteers and does not take the responsibility lightly.
"The expected value is even having a vaccine one day faster," Morrison said."We want people to see that there are people enthusiastic about this." Related: A Trump administration official said the U.S. is already a leader in the fight against the virus with over $2.4 billion committed to global health, aid."We must continue to ask the question, are we there yet?" said Dr. James Giordano, professor of neurology and biochemistry and bioethicist at Georgetown University Medical Center.
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